Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-01-24 @ 4:18 PM
Study NCT ID:
NCT02150967
Status:
TERMINATED
Last Update Posted:
2023-07-03
First Post:
2014-05-12
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase II, Single Arm Study of BGJ398 in Patients With Advanced Cholangiocarcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['France']}, 'conditionBrowseModule': {'meshes': [{'id': 'D018281', 'term': 'Cholangiocarcinoma'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C568950', 'term': 'infigratinib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'david.vanveenhuyzen@bridgebio.com', 'phone': '1 650 391-9740', 'title': 'David van Veenhuyzen, Vice President, Clinical Development', 'phoneExt': '103', 'organization': 'QED Therapeutics, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.', 'description': 'Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0.\n\nUnless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort 1: FGFR2 Fusions', 'description': 'Infigratinib 125 mg once daily (3 wk on/1 wk off treatment)', 'otherNumAtRisk': 108, 'deathsNumAtRisk': 108, 'otherNumAffected': 107, 'seriousNumAtRisk': 108, 'deathsNumAffected': 93, 'seriousNumAffected': 35}, {'id': 'EG001', 'title': 'Cohort 2: Other FGFR Genetic Alterations', 'description': 'Infigratinib 125 mg once daily (3 wk on/1 wk off treatment)', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 25, 'seriousNumAtRisk': 25, 'deathsNumAffected': 19, 'seriousNumAffected': 11}, {'id': 'EG002', 'title': 'Cohort 3: FGFR2 Fusions and Prior FGFR Inhibitor', 'description': 'Infigratinib 125 mg once daily (3 wk on/1 wk off treatment)', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 10, 'seriousNumAtRisk': 10, 'deathsNumAffected': 7, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Trichiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Blepharitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Chorioretinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Punctate keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Cataract nuclear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Growth of eyelashes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Ocular hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Subretinal fluid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Oral dysaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Paronychia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Amylase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Hyperphosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 83}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Hypercalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Hypertriglyceridaemia', 'stats': [{'groupId': 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Device occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Response Rate (ORR) as Assessed by Blinded Independent Central Imaging Review (BICR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: FGFR2 Fusions', 'description': 'Infigratinib 125 mg once daily (3 wk on/1 wk off treatment)'}], 'classes': [{'categories': [{'measurements': [{'value': '23.1', 'groupId': 'OG000', 'lowerLimit': '15.6', 'upperLimit': '32.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Analysis was conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021.', 'description': 'ORR is defined as the percentage (%) of subjects with a best overall response of Complete Response (CR) or Partial Response (PR), as per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1, evaluated by computed tomography (CT) or magnetic resonance imaging (MRI) scans every 28 days.\n\nRECIST (v1.1) response criteria were as follows:\n\nCR: disappearance of all target lesions. Any pathological lymph node (whether target or non-target) must have reduction in short axis to \\<10 mm.\n\nPR: at least a 30% decrease from baseline in the sum of diameters of all target lesions.\n\nNote: The primary efficacy outcome measures were prespecified only for Cohort 1 (FGFR fusions). Results were previously disclosed (22 June 2022). There are no additional efficacy endpoints to assess for Cohort 1, thus efficacy data were not re-analyzed for the final analysis.\n\nDue to early termination of the study, no formal efficacy analyses were performed for Cohorts 2 and 3.', 'unitOfMeasure': 'Percentage (%) of subjects with CR or PR', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS), defined as all subjects in Cohort 1 who had received at least one dose of infigratinib.'}, {'type': 'SECONDARY', 'title': 'Overall Response Rate (ORR) as Assessed by the Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: FGFR2 Fusion/Rearrangements', 'description': 'Infigratinib 125 mg once daily (3 wk on/1 wk off treatment)'}], 'classes': [{'categories': [{'measurements': [{'value': '32.4', 'groupId': 'OG000', 'lowerLimit': '23.7', 'upperLimit': '42.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff for the primary analysis was 01 March 2021.', 'description': 'ORR is defined as the percentage (%) of subjects with a best overall response of CR or PR, evaluated by CT or MRI scans every 28 days.\n\nRECIST (v1.1) response criteria were as follows:\n\nCR: disappearance of all target lesions. Any pathological lymph node (whether target or non-target) must have reduction in short axis to \\<10 mm.\n\nPR: at least a 30% decrease from baseline in the sum of diameters of all target lesions.\n\nNote: The primary efficacy outcome measures were prespecified only for Cohort 1 (FGFR fusions) only. These results were previously disclosed (22 June 2022).\n\nThere are no additional efficacy endpoints to assess for Cohort 1, thus efficacy data were not re-analyzed for the final analysis.\n\nDue to early termination of the study, no formal efficacy analyses were performed for Cohorts 2 and 3.', 'unitOfMeasure': 'Percentage (%) of subjects with CR or PR', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS), defined as all subjects in Cohort 1 who had received at least one dose of infigratinib.'}, {'type': 'SECONDARY', 'title': 'Best Overall Response (BOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: FGFR2 Fusion/Rearrangements', 'description': 'Infigratinib 125 mg once daily (3 wk on/1 wk off treatment)'}], 'classes': [{'title': 'BOR by BICR', 'categories': [{'title': 'Confirmed CR', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Confirmed PR', 'measurements': [{'value': '24', 'groupId': 'OG000'}]}, {'title': 'Stable Disease', 'measurements': [{'value': '66', 'groupId': 'OG000'}]}, {'title': 'Progressive Disease', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}, {'title': 'Not Done', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'BOR by Investigator', 'categories': [{'title': 'Confirmed CR', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Confirmed PR', 'measurements': [{'value': '35', 'groupId': 'OG000'}]}, {'title': 'Stable Disease', 'measurements': [{'value': '56', 'groupId': 'OG000'}]}, {'title': 'Progressive Disease', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}, {'title': 'Not Done', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021.', 'description': 'BOR is defined as the best overall response a subject achieved during the study before any subsequent antineoplastic therapy. The endpoint is summarized for the rate of BOR of CR, PR, progressive disease (PD), and stable disease (SD), evaluated by CT or MRI scans every 28 days.\n\nRECIST (v1.1) response criteria were as follows:\n\nCR: disappearance of all target lesions. Any pathological lymph node (whether target or non-target) must have reduction in short axis to \\<10 mm.\n\nPR: at least a 30% decrease from baseline in the sum of diameters of all target lesions.\n\nPD: at least a 20% increase in the sum of diameters of all target lesions from that of the smallest sum on study and an absolute increase in target lesion of at least 5mm.\n\nSD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on study.\n\nNote: The primary efficacy outcome measures were prespecified only for Cohort 1 (FGFR fusion)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS), defined as all subjects in Cohort 1 who had received at least one dose of infigratinib.'}, {'type': 'SECONDARY', 'title': 'Disease Control Rate (DCR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: FGFR2 Fusion/Rearrangements', 'description': 'Infigratinib 125 mg once daily (3 wk on/1 wk off treatment)'}], 'classes': [{'title': 'DCR by BICR', 'categories': [{'measurements': [{'value': '84.3', 'groupId': 'OG000', 'lowerLimit': '76.0', 'upperLimit': '90.6'}]}]}, {'title': 'DCR by Investigator', 'categories': [{'measurements': [{'value': '84.3', 'groupId': 'OG000', 'lowerLimit': '76.0', 'upperLimit': '90.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021.', 'description': 'DCR is the percentage (%) of subjects with a BOR of CR, PR, or SD, evaluated by CT or MRI scans every 28 days.\n\nResults are based on both BICR and on Investigator assessment.\n\nRECIST (v1.1) response criteria were as follows:\n\nCR: disappearance of all target lesions. Any pathological lymph node (whether target or non-target) must have reduction in short axis to \\<10 mm.\n\nPR: at least a 30% decrease from baseline in the sum of diameters of all target lesions.\n\nSD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on study.\n\nNote: The primary efficacy outcome measures were prespecified only for Cohort 1 (FGFR fusions) (disclosed 22 June 2022).\n\nThere are no additional efficacy endpoints to assess for Cohort 1, thus efficacy data were not re-analyzed for the final analysis.\n\nDue to early termination of the study, no formal efficacy analyses were performed for Cohorts 2 and 3.', 'unitOfMeasure': 'Percentage (%) with CR, PR, or SD', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS), defined as all subjects in Cohort 1 who had received at least one dose of infigratinib.'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: FGFR2 Fusion/Rearrangements', 'description': 'Infigratinib 125 mg once daily (3 wk on/1 wk off treatment)'}], 'classes': [{'title': 'PFS by BICR', 'categories': [{'measurements': [{'value': '7.29', 'groupId': 'OG000', 'lowerLimit': '5.59', 'upperLimit': '7.56'}]}]}, {'title': 'PFS by Investigator', 'categories': [{'measurements': [{'value': '6.74', 'groupId': 'OG000', 'lowerLimit': '5.55', 'upperLimit': '7.56'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021.', 'description': 'PFS was calculated as the number of months from the first dose of study drug to the first documented progression or death due to any cause, whichever occurred earlier. Subjects without an assessment of progression or death were censored at the last adequate tumor assessment. For subjects who had an event after ≥2 missed visits, the subject was censored at the last adequate tumor assessment before the missing visit.\n\nDisease progression was assessed per RECIST (v1.1) and defined as at least a 20% increase in the sum of diameters of all target lesions from that of the smallest sum on study and an absolute increase in target lesion of at least 5mm.\n\nResults are based on both BICR and on Investigator assessment.\n\nNote: The primary efficacy outcome measures were prespecified only for Cohort 1 (FGFR fusions) (disclosed 22 June 2022).\n\nDue to early termination of the study, no formal efficacy analyses were performed for Cohorts 2 and 3.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS), defined as all subjects in Cohort 1 who had received at least one dose of infigratinib.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: FGFR2 Fusion/Rearrangements', 'description': 'Infigratinib 125 mg once daily (3 wk on/1 wk off treatment)'}], 'classes': [{'categories': [{'measurements': [{'value': '11.86', 'groupId': 'OG000', 'lowerLimit': '10.68', 'upperLimit': '14.85'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021.', 'description': 'OS was defined as the time (months) from the date of start of treatment to the date of death due to any cause.\n\nNote: The primary efficacy outcome measures were prespecified only for Cohort 1 (FGFR fusions) (disclosed 22 June 2022).\n\nDue to early termination of the study, no formal efficacy analyses were performed for Cohorts 2 and 3.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS), defined as all subjects in Cohort 1 who had received at least one dose of infigratinib.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: FGFR2 Fusion/Rearrangements', 'description': 'Infigratinib 125 mg once daily (3 wk on/1 wk off treatment)'}], 'classes': [{'title': 'DOR by BICR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.55', 'groupId': 'OG000', 'lowerLimit': '3.78', 'upperLimit': '7.66'}]}]}, {'title': 'DOR by Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.23', 'groupId': 'OG000', 'lowerLimit': '5.16', 'upperLimit': '9.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021.', 'description': 'DOR is defined as the time (months) from the initial response to the time of the event; defined as the first documented progression or death due to any cause, whichever was earlier.\n\nNote that results are based on a subgroup of subjects with confirmed responses (CR or PR) as assessed by BICR or by the Investigator.\n\nRECIST (v1.1) response criteria was as follows:\n\nCR: disappearance of all target lesions. Any pathological lymph node (whether target or non-target) must have reduction in short axis to \\<10 mm.\n\nPR: at least a 30% decrease from baseline in the sum of diameters of all target lesions.\n\nNote: The primary efficacy outcome measures were prespecified only for Cohort 1 (FGFR fusions) (disclosed 22 June 2022).\n\nDue to early termination of the study, no formal efficacy analyses were performed for Cohorts 2 and 3.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS), defined as all subjects in Cohort 1 who had received at least one dose of infigratinib. Conducted in a subgroup of subjects who were confirmed responders (CR or PR) as assessed by BICR (N = 25) or by the Investigator (N = 35).'}, {'type': 'SECONDARY', 'title': 'Response Onset', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: FGFR2 Fusion/Rearrangements', 'description': 'Infigratinib 125 mg once daily (3 wk on/1 wk off treatment)'}], 'classes': [{'title': 'Response onset by BICR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.61', 'groupId': 'OG000', 'lowerLimit': '1.38', 'upperLimit': '7.36'}]}]}, {'title': 'Response onset by Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.94', 'groupId': 'OG000', 'lowerLimit': '1.38', 'upperLimit': '18.76'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021.', 'description': 'Response onset was defined as the time (months) from the first study treatment administration date to the initial response.\n\nNote that results are based on a subgroup of subjects with confirmed responses (CR or PR) as assessed by BICR or by the Investigator.\n\nRECIST (v1.1) response criteria was as follows:\n\nCR: disappearance of all target lesions. Any pathological lymph node (whether target or non-target) must have reduction in short axis to \\<10 mm.\n\nPR: at least a 30% decrease from baseline in the sum of diameters of all target lesions.\n\nNote: The primary efficacy outcome measures were prespecified only for Cohort 1 (FGFR fusions) (disclosed 22 June 2022).\n\nDue to early termination of the study, no formal efficacy analyses were performed for Cohorts 2 and 3.', 'unitOfMeasure': 'months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS), defined as all subjects in Cohort 1 who had received at least one dose of infigratinib. Conducted in a subgroup of subjects who were confirmed responders (CR or PR) as assessed by BICR (N = 25) or by the Investigator (N = 35).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Growth Modulation Index (GMI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: FGFR2 Fusion/Rearrangements', 'description': 'Infigratinib 125 mg once daily (3 wk on/1 wk off treatment)'}], 'classes': [{'title': 'PFS by BICR', 'categories': [{'measurements': [{'value': '1.22', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '120'}]}]}, {'title': 'PFS by Investigator', 'categories': [{'measurements': [{'value': '1.24', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '120'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021.', 'description': 'The GMI is defined as the ratio of PFS (months) during treatment with infigratinib relative to the time (months) to progression (TTP) during treatment with last prior line of therapy.\n\nSubjects served as their own control.\n\nResults are provided for both BICR and Investigator assessment.\n\nNote: The primary efficacy outcome measures were prespecified only for Cohort 1 (FGFR fusions) (disclosed 22 June 2022).\n\nDue to early termination of the study, no formal efficacy analyses were performed for Cohorts 2 and 3.', 'unitOfMeasure': 'Ratio (PFS/TTP) in Months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS), defined as all subjects in Cohort 1 who had received at least one dose of infigratinib. Conducted in a subgroup of subjects with both a PFS measure while on infigratinib and available TTP for their last prior line of therapy (N = 103).'}, {'type': 'POST_HOC', 'title': 'Retrospective Analysis of Post-second-line Antineoplastic Treatment Outcomes on ORR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: FGFR2 Fusion/Rearrangements', 'description': 'Infigratinib 125 mg once daily (3 wk on/1 wk off treatment)'}], 'classes': [{'title': 'After Second-Line Therapy (Prior to Infigratinib Treatment)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '6.1'}]}]}, {'title': 'Third or Later-Line Therapy (Infigratinib)', 'categories': [{'measurements': [{'value': '28.8', 'groupId': 'OG000', 'lowerLimit': '17.8', 'upperLimit': '42.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021.', 'description': "Post-hoc subgroup assessment of efficacy in those subjects who were receiving infigratinib as a third or later line of treatment.\n\nInvestigator-assessed ORR was obtained from subjects' medical histories to provide a baseline evaluation of their response after historical second-line antineoplastic treatment prior to infigratinib treatment. Investigator-assessed ORR was then calculated in the same subjects after third- or later-line infigratinib therapy.\n\nORR is defined as the percentage (%) of patients with CR or PR, per RECIST (v1.1).\n\nRECIST (v1.1) response criteria were as follows:\n\nCR: disappearance of all target lesions. Any pathological lymph node (whether target or non-target) must have reduction in short axis to \\<10 mm.\n\nPR: at least a 30% decrease from baseline in the sum of diameters of all target lesions.\n\nNote: The primary efficacy outcome measures were prespecified only for Cohort 1 (22 June 2022).\n\nNo formal efficacy analyses were performed for Cohorts 2 and 3.", 'unitOfMeasure': 'Percentage (%) of patients with CR or PR', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS), defined as all subjects in Cohort 1 who had received at least one dose of infigratinib Conducted in a subgroup of subjects who were receiving infigratinib as a third or later line of treatment (N = 59).'}, {'type': 'POST_HOC', 'title': 'Retrospective Analysis of Post-second-line Antineoplastic Treatment Outcomes on PFS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: FGFR2 Fusion/Rearrangements', 'description': 'Infigratinib 125 mg once daily (3 wk on/1 wk off treatment)'}], 'classes': [{'title': 'After Second-Line Therapy (Prior to Infigratinib Treatment)', 'categories': [{'measurements': [{'value': '5.36', 'groupId': 'OG000', 'lowerLimit': '3.25', 'upperLimit': '8.15'}]}]}, {'title': 'Third or Later-Line Therapy (Infigratinib)', 'categories': [{'measurements': [{'value': '6.93', 'groupId': 'OG000', 'lowerLimit': '4.76', 'upperLimit': '7.59'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021.', 'description': "Post-hoc subgroup assessment of efficacy in those subjects who were receiving infigratinib as a third or later line of treatment.\n\nInvestigator-assessed PFS was obtained from subjects' medical histories to provide a baseline evaluation of their response after historical second-line antineoplastic treatment prior to infigratinib treatment. Investigator-assessed PFS was then calculated in the same subjects after third- or later-line infigratinib therapy.\n\nNote: The primary efficacy outcome measures were prespecified only for Cohort 1 (FGFR fusions) (disclosed 22 June 2022).\n\nDue to early termination of the study, no formal efficacy analyses were performed for Cohorts 2 and 3.", 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS), defined as all subjects in Cohort 1 who had received at least one dose of infigratinib. Conducted in a subgroup of subjects who were receiving infigratinib as a third or later line of treatment (N=59).'}, {'type': 'POST_HOC', 'title': 'Retrospective Analysis of Post-second-line Antineoplastic Treatment Outcomes on BOR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: FGFR2 Fusion/Rearrangements', 'description': 'Infigratinib 125 mg once daily (3 wk on/1 wk off treatment)'}], 'classes': [{'title': 'After Second-Line Therapy (Prior to Infigratinib Treatment)', 'categories': [{'title': 'Complete response', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Partial response', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Stable disease', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}, {'title': 'Progressive disease', 'measurements': [{'value': '22', 'groupId': 'OG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '18', 'groupId': 'OG000'}]}, {'title': 'Not done', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Third or Later-Line Therapy (Infigratinib)', 'categories': [{'title': 'Complete response', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Partial response', 'measurements': [{'value': '17', 'groupId': 'OG000'}]}, {'title': 'Stable disease', 'measurements': [{'value': '31', 'groupId': 'OG000'}]}, {'title': 'Progressive disease', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Not done', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021.', 'description': "Post-hoc subgroup assessment of efficacy in those subjects who were receiving infigratinib as a third or later line of treatment.\n\nInvestigator-assessed BOR was obtained from subjects' medical histories to provide a baseline evaluation of their response after historical second-line antineoplastic treatment prior to infigratinib treatment. Investigator-assessed BOR was then calculated in the same subjects after third- or later-line infigratinib therapy.\n\nThe endpoint is summarized for the rate of BOR of PD, SD, PR, and CR.\n\nNote: The primary efficacy outcome measures were prespecified only for Cohort 1 (FGFR fusions) (disclosed 22 June 2022).\n\nDue to early termination of the study, no formal efficacy analyses were performed for Cohorts 2 and 3.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS), defined as all subjects in Cohort 1 who had received at least one dose of infigratinib Conducted in a subgroup of subjects who were receiving infigratinib as a third or later line of treatment (N=59).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort 1: FGFR2 Fusions', 'description': 'Infigratinib 125 mg once daily (3 wk on/1 wk off treatment)'}, {'id': 'FG001', 'title': 'Cohort 2: Other FGFR Alterations', 'description': 'Infigratinib 125 mg once daily (3 wk on/1 wk off treatment)'}, {'id': 'FG002', 'title': 'Cohort 3: FGFR2 Fusions and Prior FGFR Inhibitor', 'description': 'Infigratinib 125 mg once daily (3 wk on/1 wk off treatment)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '108'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'Treatment Ongoing', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Treatment Ended', 'comment': 'Per protocol, patients continue treatment until radiographical documentation of disease progression.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '108'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'comment': 'Cohort 1: completed is defined as patients who had the opportunity to be followed for at least 10 months after their initial exposure of infigratinib. This cohort supports the primary efficacy analysis of the study\n\nCohort 2 and 3: completed is defined as patients who may have had the opportunity to be followed for at least 10 months after their initial exposure of infigratinib or up to the time of study termination.\n\nThese cohorts support only the exploratory endpoints of the study', 'achievements': [{'comment': 'Cohort 1 (FGFR2 fusions): Primary efficacy outcome measures were prespecified only for this cohort.', 'groupId': 'FG000', 'numSubjects': '108'}, {'comment': 'Cohort 2 (Other FGFR Alterations): not the primary efficacy analysis population.', 'groupId': 'FG001', 'numSubjects': '25'}, {'comment': 'Cohort 3 (FGFR2 fusions and prior FGFR inhibitor): not the primary efficacy analysis population.', 'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants with a diagnosis of advanced or metastatic cholangiocarcinoma were recruited to this open-label, single-arm global study across 20 centers (9 in the US, 5 in W. Europe, 6 in Asia) based on documented evidence of FGFR gene alteration. The first participant was treated on 23 July 2014. The data cutoff for the primary analysis (Cohort 1 only) was 01 March 2021.The data cutoff for the final analysis (Cohort 2 and 3 only) was 07 February 2022.', 'preAssignmentDetails': 'Subjects meeting inclusion/exclusion criteria were enrolled into the following cohorts:\n\nCohort 1 (FGFR2 fusions): Primary analysis population (N=108). Cohort 2 (Other FGFR alterations): N=25. Cohort 3 (FGFR2 fusions and prior FGFR inhibitor): N=10.\n\nNote:\n\nPrimary efficacy outcome measures were prespecified only for Cohort 1. Cohorts 2 and 3 were added following PA 4 to support exploratory objectives only.\n\nCohorts 2 and 3 are not the primary analysis population.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '143', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort 1: FGFR2 Fusions', 'description': 'Infigratinib 125 mg once daily (3 wk on/1 wk off treatment)'}, {'id': 'BG001', 'title': 'Cohort 2: Other FGFR Genetic Alterations', 'description': 'Infigratinib 125 mg once daily (3 wk on/1 wk off treatment)'}, {'id': 'BG002', 'title': 'Cohort 3: FGFR2 Fusions and Prior FGFR Inhibitor', 'description': 'Infigratinib 125 mg once daily (3 wk on/1 wk off treatment)'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '143', 'groupId': 'BG003'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '107', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '143', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '53.4', 'spread': '13.08', 'groupId': 'BG000'}, {'value': '59.9', 'spread': '9.89', 'groupId': 'BG001'}, {'value': '51.8', 'spread': '12.07', 'groupId': 'BG002'}, {'value': '54.0', 'spread': '12.88', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '143', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '82', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '143', 'groupId': 'BG003'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '108', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'North America', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '143', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '94', 'groupId': 'BG003'}]}]}, {'title': 'Europe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '143', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}]}]}, {'title': 'South Korea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '143', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Singapore', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '143', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}, {'title': 'Taiwan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '143', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Thailand', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '143', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'ECOG PS', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '143', 'groupId': 'BG003'}]}], 'categories': [{'title': '0', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}]}, {'title': '1', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '82', 'groupId': 'BG003'}]}, {'title': '2', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Functional status was assessed at baseline using the Eastern Cooperative Oncology Group Performance Scale (ECOG PS), defined as follows:\n\n0\\. Fully active, able to carry out all pre-disease performance without restriction.\n\n1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature.\n2. Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours.\n3. Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours.\n4. Completely disabled.', 'unitOfMeasure': 'Participants'}, {'title': 'Primary site of cancer', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '143', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Bile Duct', 'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '139', 'groupId': 'BG003'}]}, {'title': 'Cholangiocarcinoma', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Liver', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Non-Liver Metastatic Site', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '143', 'groupId': 'BG003'}]}], 'categories': [{'title': 'No metastatic site', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}, {'title': 'Had metastatic site', 'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '133', 'groupId': 'BG003'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Non-Liver Metastatic Site', 'classes': [{'title': 'Bone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '143', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}]}]}, {'title': 'Lung', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '143', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '85', 'groupId': 'BG003'}]}]}, {'title': 'Node', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '143', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '143', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Data represent the number of patients in the FAS with at least one metastatic site. Note that for some patients, metastases may have been reported at more than one site.', 'unitOfMeasure': 'Participants'}, {'title': 'Time from initial diagnosis to first dose day', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '143', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '12.75', 'groupId': 'BG000', 'lowerLimit': '1.74', 'upperLimit': '152.94'}, {'value': '16.49', 'groupId': 'BG001', 'lowerLimit': '5.62', 'upperLimit': '176.59'}, {'value': '22.11', 'groupId': 'BG002', 'lowerLimit': '11.86', 'upperLimit': '61.80'}, {'value': '15', 'groupId': 'BG003', 'lowerLimit': '1.74', 'upperLimit': '176.59'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'months', 'dispersionType': 'FULL_RANGE'}, {'title': 'Time from the most recent recurrence/progression to the first dose day', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '131', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '1.40', 'groupId': 'BG000', 'lowerLimit': '0.03', 'upperLimit': '14.59'}, {'value': '1.31', 'groupId': 'BG001', 'lowerLimit': '0.30', 'upperLimit': '8.28'}, {'value': '1.36', 'groupId': 'BG002', 'lowerLimit': '0.49', 'upperLimit': '13.74'}, {'value': '1.36', 'groupId': 'BG003', 'lowerLimit': '0.03', 'upperLimit': '14.59'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'months', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'The date of most recent recurrence/progression is based on medical history which may not have been available for all patients.'}, {'title': 'Histological Grade', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '143', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Well differentiated', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}, {'title': 'Moderately differentiated', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}]}, {'title': 'Poorly differentiated', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}]}, {'title': 'Undifferentiated', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Unknown/missing', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}, {'title': 'Not Applicable', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Stage at Time of Study Entry', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '143', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Stage II', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Stage III', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Stage IV', 'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '137', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The AJCC staging manual (7th edition) for intrahepatic cholangiocarcinoma was used for cancer staging at baseline, defined as follows:\n\nStage I: solitary tumor without vascular invasion. Stage II: solitary tumor with vascular invasion or multiple tumors with or without vascular invasion.\n\nStage III: tumor perforating the visceral peritoneum or involving local hepatic structure by direct invasion.\n\nStage IV: tumor with periductal invasion, or any tumor with regional lymph node metastasis present, or any tumor with or without lymph node metastasis but metastasized to a distant site.', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full Analysis Set (FAS), defined as all subjects who had received at least 1 dose of infigratinib.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-01-15', 'size': 1352120, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-02-19T16:52', 'hasProtocol': True}, {'date': '2020-05-13', 'size': 841591, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-02-19T16:54', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 143}}, 'statusModule': {'whyStopped': 'The study was terminated early due to limited efficacy in Cohorts 2 and 3 (exploratory endpoints). Termination was not due to concerns about safety and had no impact on the primary efficacy analysis (ie, results reported for Cohort 1).', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-07-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2022-02-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-29', 'studyFirstSubmitDate': '2014-05-12', 'resultsFirstSubmitDate': '2022-02-22', 'studyFirstSubmitQcDate': '2014-05-27', 'lastUpdatePostDateStruct': {'date': '2023-07-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-06-22', 'studyFirstPostDateStruct': {'date': '2014-05-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Growth Modulation Index (GMI)', 'timeFrame': 'Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021.', 'description': 'The GMI is defined as the ratio of PFS (months) during treatment with infigratinib relative to the time (months) to progression (TTP) during treatment with last prior line of therapy.\n\nSubjects served as their own control.\n\nResults are provided for both BICR and Investigator assessment.\n\nNote: The primary efficacy outcome measures were prespecified only for Cohort 1 (FGFR fusions) (disclosed 22 June 2022).\n\nDue to early termination of the study, no formal efficacy analyses were performed for Cohorts 2 and 3.'}], 'primaryOutcomes': [{'measure': 'Overall Response Rate (ORR) as Assessed by Blinded Independent Central Imaging Review (BICR)', 'timeFrame': 'Analysis was conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021.', 'description': 'ORR is defined as the percentage (%) of subjects with a best overall response of Complete Response (CR) or Partial Response (PR), as per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1, evaluated by computed tomography (CT) or magnetic resonance imaging (MRI) scans every 28 days.\n\nRECIST (v1.1) response criteria were as follows:\n\nCR: disappearance of all target lesions. Any pathological lymph node (whether target or non-target) must have reduction in short axis to \\<10 mm.\n\nPR: at least a 30% decrease from baseline in the sum of diameters of all target lesions.\n\nNote: The primary efficacy outcome measures were prespecified only for Cohort 1 (FGFR fusions). Results were previously disclosed (22 June 2022). There are no additional efficacy endpoints to assess for Cohort 1, thus efficacy data were not re-analyzed for the final analysis.\n\nDue to early termination of the study, no formal efficacy analyses were performed for Cohorts 2 and 3.'}], 'secondaryOutcomes': [{'measure': 'Overall Response Rate (ORR) as Assessed by the Investigator', 'timeFrame': 'Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff for the primary analysis was 01 March 2021.', 'description': 'ORR is defined as the percentage (%) of subjects with a best overall response of CR or PR, evaluated by CT or MRI scans every 28 days.\n\nRECIST (v1.1) response criteria were as follows:\n\nCR: disappearance of all target lesions. Any pathological lymph node (whether target or non-target) must have reduction in short axis to \\<10 mm.\n\nPR: at least a 30% decrease from baseline in the sum of diameters of all target lesions.\n\nNote: The primary efficacy outcome measures were prespecified only for Cohort 1 (FGFR fusions) only. These results were previously disclosed (22 June 2022).\n\nThere are no additional efficacy endpoints to assess for Cohort 1, thus efficacy data were not re-analyzed for the final analysis.\n\nDue to early termination of the study, no formal efficacy analyses were performed for Cohorts 2 and 3.'}, {'measure': 'Best Overall Response (BOR)', 'timeFrame': 'Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021.', 'description': 'BOR is defined as the best overall response a subject achieved during the study before any subsequent antineoplastic therapy. The endpoint is summarized for the rate of BOR of CR, PR, progressive disease (PD), and stable disease (SD), evaluated by CT or MRI scans every 28 days.\n\nRECIST (v1.1) response criteria were as follows:\n\nCR: disappearance of all target lesions. Any pathological lymph node (whether target or non-target) must have reduction in short axis to \\<10 mm.\n\nPR: at least a 30% decrease from baseline in the sum of diameters of all target lesions.\n\nPD: at least a 20% increase in the sum of diameters of all target lesions from that of the smallest sum on study and an absolute increase in target lesion of at least 5mm.\n\nSD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on study.\n\nNote: The primary efficacy outcome measures were prespecified only for Cohort 1 (FGFR fusion)'}, {'measure': 'Disease Control Rate (DCR)', 'timeFrame': 'Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021.', 'description': 'DCR is the percentage (%) of subjects with a BOR of CR, PR, or SD, evaluated by CT or MRI scans every 28 days.\n\nResults are based on both BICR and on Investigator assessment.\n\nRECIST (v1.1) response criteria were as follows:\n\nCR: disappearance of all target lesions. Any pathological lymph node (whether target or non-target) must have reduction in short axis to \\<10 mm.\n\nPR: at least a 30% decrease from baseline in the sum of diameters of all target lesions.\n\nSD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on study.\n\nNote: The primary efficacy outcome measures were prespecified only for Cohort 1 (FGFR fusions) (disclosed 22 June 2022).\n\nThere are no additional efficacy endpoints to assess for Cohort 1, thus efficacy data were not re-analyzed for the final analysis.\n\nDue to early termination of the study, no formal efficacy analyses were performed for Cohorts 2 and 3.'}, {'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021.', 'description': 'PFS was calculated as the number of months from the first dose of study drug to the first documented progression or death due to any cause, whichever occurred earlier. Subjects without an assessment of progression or death were censored at the last adequate tumor assessment. For subjects who had an event after ≥2 missed visits, the subject was censored at the last adequate tumor assessment before the missing visit.\n\nDisease progression was assessed per RECIST (v1.1) and defined as at least a 20% increase in the sum of diameters of all target lesions from that of the smallest sum on study and an absolute increase in target lesion of at least 5mm.\n\nResults are based on both BICR and on Investigator assessment.\n\nNote: The primary efficacy outcome measures were prespecified only for Cohort 1 (FGFR fusions) (disclosed 22 June 2022).\n\nDue to early termination of the study, no formal efficacy analyses were performed for Cohorts 2 and 3.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021.', 'description': 'OS was defined as the time (months) from the date of start of treatment to the date of death due to any cause.\n\nNote: The primary efficacy outcome measures were prespecified only for Cohort 1 (FGFR fusions) (disclosed 22 June 2022).\n\nDue to early termination of the study, no formal efficacy analyses were performed for Cohorts 2 and 3.'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021.', 'description': 'DOR is defined as the time (months) from the initial response to the time of the event; defined as the first documented progression or death due to any cause, whichever was earlier.\n\nNote that results are based on a subgroup of subjects with confirmed responses (CR or PR) as assessed by BICR or by the Investigator.\n\nRECIST (v1.1) response criteria was as follows:\n\nCR: disappearance of all target lesions. Any pathological lymph node (whether target or non-target) must have reduction in short axis to \\<10 mm.\n\nPR: at least a 30% decrease from baseline in the sum of diameters of all target lesions.\n\nNote: The primary efficacy outcome measures were prespecified only for Cohort 1 (FGFR fusions) (disclosed 22 June 2022).\n\nDue to early termination of the study, no formal efficacy analyses were performed for Cohorts 2 and 3.'}, {'measure': 'Response Onset', 'timeFrame': 'Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021.', 'description': 'Response onset was defined as the time (months) from the first study treatment administration date to the initial response.\n\nNote that results are based on a subgroup of subjects with confirmed responses (CR or PR) as assessed by BICR or by the Investigator.\n\nRECIST (v1.1) response criteria was as follows:\n\nCR: disappearance of all target lesions. Any pathological lymph node (whether target or non-target) must have reduction in short axis to \\<10 mm.\n\nPR: at least a 30% decrease from baseline in the sum of diameters of all target lesions.\n\nNote: The primary efficacy outcome measures were prespecified only for Cohort 1 (FGFR fusions) (disclosed 22 June 2022).\n\nDue to early termination of the study, no formal efficacy analyses were performed for Cohorts 2 and 3.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cholangiocarcinoma,', 'FGFR2 gene fusion,', 'FGFR genetic alteration'], 'conditions': ['Advanced Cholangiocarcinoma', 'FGFR2 Gene Mutation']}, 'referencesModule': {'references': [{'pmid': '34358484', 'type': 'DERIVED', 'citation': 'Javle M, Roychowdhury S, Kelley RK, Sadeghi S, Macarulla T, Weiss KH, Waldschmidt DT, Goyal L, Borbath I, El-Khoueiry A, Borad MJ, Yong WP, Philip PA, Bitzer M, Tanasanvimon S, Li A, Pande A, Soifer HS, Shepherd SP, Moran S, Zhu AX, Bekaii-Saab TS, Abou-Alfa GK. Infigratinib (BGJ398) in previously treated patients with advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements: mature results from a multicentre, open-label, single-arm, phase 2 study. Lancet Gastroenterol Hepatol. 2021 Oct;6(10):803-815. doi: 10.1016/S2468-1253(21)00196-5. Epub 2021 Aug 3.'}, {'pmid': '29182496', 'type': 'DERIVED', 'citation': 'Javle M, Lowery M, Shroff RT, Weiss KH, Springfeld C, Borad MJ, Ramanathan RK, Goyal L, Sadeghi S, Macarulla T, El-Khoueiry A, Kelley RK, Borbath I, Choo SP, Oh DY, Philip PA, Chen LT, Reungwetwattana T, Van Cutsem E, Yeh KH, Ciombor K, Finn RS, Patel A, Sen S, Porter D, Isaacs R, Zhu AX, Abou-Alfa GK, Bekaii-Saab T. Phase II Study of BGJ398 in Patients With FGFR-Altered Advanced Cholangiocarcinoma. J Clin Oncol. 2018 Jan 20;36(3):276-282. doi: 10.1200/JCO.2017.75.5009. Epub 2017 Nov 28.'}, {'pmid': '25763789', 'type': 'DERIVED', 'citation': 'Borad MJ, Gores GJ, Roberts LR. Fibroblast growth factor receptor 2 fusions as a target for treating cholangiocarcinoma. Curr Opin Gastroenterol. 2015 May;31(3):264-8. doi: 10.1097/MOG.0000000000000171.'}]}, 'descriptionModule': {'briefSummary': 'This is a multi-center, open label, single arm phase II study evaluating BGJ398 (infigratinib) anti-tumor activity in advanced or metastatic cholangiocarcinoma patients with fibroblast growth factor receptor (FGFR) genetic alterations.', 'detailedDescription': 'Adult patients with histologically or cytologically confirmed advanced or metastatic cholangiocarcinoma with FGFR2 gene fusions or translocations or other FGFR genetic alterations have been enrolled. Subjects must have received at least one prior regimen containing gemcitabine with or without cisplatin for advanced/metastatic disease. Subjects should have had evidence of progressive disease following their prior regimen or if prior treatment was discontinued due to toxicity must have continued evidence of measurable disease. Up to approximately 160 adult patients over age 18, both male and female were planned for enrollment.\n\nThree cohorts of subjects comprise the study population:\n\nCohort 1: subjects with FGFR2 gene fusions (ie, fusions or rearrangements \\[formerly translocations\\]).\n\nCohort 2: subjects with FGFR genetic alterations other than FGFR2 gene fusions or rearrangements.\n\nCohort 3: subjects with FGFR2 gene fusions or rearrangements who have received a prior FGFR inhibitor.\n\nAll subjects received oral BGJ398 (infigratinib), once-daily, on a three weeks on (21 days), one week off (7 days) schedule. One treatment cycle consists of 28 days.\n\nNotes:\n\nCohort 1 was pre-specified as the primary analysis population. Results of these analyses were previously disclosed (posted 22 June 2022). There were no additional efficacy or safety endpoints to assess in Cohort 1 after primary completion (01 March 2021).\n\nCohorts 2 and 3 were added at protocol amendment (PA) 4 to support only exploratory efficacy objectives of the study. These cohorts were ongoing the time of primary completion (01 March 2021). After interim review of the data from these cohorts (as permitted by the protocol) only limited efficacy was observed and the sponsor terminated the study early. Therefore, a formal efficacy analysis was not performed for Cohorts 2 and 3. However, baseline characteristics and safety data were analyzed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n\\- Adult patients with histologically or cytologically confirmed cholangiocarcinoma at the time of diagnosis.\n\nPatients with cancers of the gallbladder or ampulla of Vater are not eligible.\n\n\\- Patients must have received at least one prior regimen containing gemcitabine with or without cisplatin for advanced/ metastatic disease. Patient should have evidence of progressive disease following prior regimen, or if prior treatment discontinued due to toxicity must have continued evidence of measurable or evaluable disease.\n\nExclusion criteria:\n\n* Prior or current treatment with a MEK inhibitor (all Cohorts), BGJ398 (infigratinib) (all Cohorts), or selective FGFR inhibitor (Cohorts 1 and 2 only).\n* insufficient organ function\n\n * Absolute Neutrophil Count (ANC) \\< 1,000/mm3 \\[1.0 x 10\\^9/L\\]\n * Platelets \\< 75,000/mm3 \\[75 x 10\\^9/L\\]\n * Hemoglobin \\< 109.0 g/dL\n * Total bilirubin \\> 1.5x upper limit of normal (ULN)\n * Aspartate aminotransferase/glutamic oxaloacetic transaminase (AST/SGOT) and alanine aminotransferase/glutamic pyruvic transaminase (ALT/SGPT) \\> 2.5x ULN (AST and ALT \\> 5x ULN in the presence of liver metastases)\n * Serum creatinine \\> 1.5x ULN and a calculated or measured creatinine clearance \\< 45 mL/min\n * Inorganic phosphorus outside of normal limits\n * Total and ionized serum calcium outside of normal limits\n\nOther protocol-defined inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT02150967', 'briefTitle': 'A Phase II, Single Arm Study of BGJ398 in Patients With Advanced Cholangiocarcinoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'QED Therapeutics, a BridgeBio company'}, 'officialTitle': 'A Phase II Multicenter, Single Arm Study of Oral BGJ398 in Adult Patients With Advanced or Metastatic Cholangiocarcinoma With FGFR2 Gene Fusions or Other FGFR Genetic Alterations Who Failed or Are Intolerant to Platinum-based Chemotherapy', 'orgStudyIdInfo': {'id': 'CBGJ398X2204'}, 'secondaryIdInfos': [{'id': '2013-005085-19', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BGJ398 (infigratinib)', 'description': 'To estimate the anti-tumor activity of BGJ398 (infigratinib)', 'interventionNames': ['Drug: BGJ398 (infigratinib)']}], 'interventions': [{'name': 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