Ignite Creation Date:
2025-12-24 @ 6:41 PM
Ignite Modification Date:
2025-12-25 @ 4:12 PM
Study NCT ID:
NCT05678257
Status:
TERMINATED
Last Update Posted:
2025-09-12
First Post:
2022-12-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of NUC-3373 in Combination With Other Agents in Patients With Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-08-24', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002955', 'term': 'Leucovorin'}, {'id': 'D000077146', 'term': 'Irinotecan'}, {'id': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'D005472', 'term': 'Fluorouracil'}], 'ancestors': [{'id': 'D005575', 'term': 'Formyltetrahydrofolates'}, {'id': 'D013763', 'term': 'Tetrahydrofolates'}, {'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'info@nucana.com', 'phone': '+44 131 357 1111', 'title': 'Medical and Scientific Affairs Department', 'organization': 'NuCana plc'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Due to the early closure of the study, many patients were censored for the efficacy endpoints and the data should therefore be interpreted with caution.'}}, 'adverseEventsModule': {'timeFrame': 'Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 months.', 'description': 'Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'NUFIRI-bev Q1W', 'description': 'Arm A: Study treatment will be administered in 28-day cycles as follows:\n\n1. Bevacizumab 5 mg/kg on Days 1 and 15:\n2. LV 400 mg/m2 (or equivalent levo-LV) over 120 minutes on Days 1, 8, 15, and 22.\n3. Irinotecan 180 mg/m2 over 90 minutes (concurrently with the LV infusion) on Days 1 and 15.\n4. NUC-3373 1500 mg/m2 over 120 minutes on Days 1, 8, 15, and 22.', 'otherNumAtRisk': 56, 'deathsNumAtRisk': 56, 'otherNumAffected': 55, 'seriousNumAtRisk': 56, 'deathsNumAffected': 18, 'seriousNumAffected': 11}, {'id': 'EG001', 'title': 'NUFIRI-bev Q2W', 'description': 'Arm B: Study treatment will be administered in 28-day cycles as follows:\n\n1. Bevacizumab 5 mg/kg on Days 1 and 15:\n2. LV 400 mg/m2 (or equivalent levo-LV) over 120 minutes on Days 1 and 15.\n3. Irinotecan 180 mg/m2 over 90 minutes (concurrently with the LV infusion) on Days 1 and 15.\n4. NUC-3373 1500 mg/m2 over 120 minutes on Days 1 and 15', 'otherNumAtRisk': 64, 'deathsNumAtRisk': 64, 'otherNumAffected': 62, 'seriousNumAtRisk': 64, 'deathsNumAffected': 14, 'seriousNumAffected': 13}, {'id': 'EG002', 'title': 'FOLFIRI-bev Q2W', 'description': 'Arm C: Study treatment will be administered in 28-day cycles as follows:\n\n1. Bevacizumab 5 mg/kg on Days 1 and 15:\n2. LV 400 mg/m2 (or equivalent levo-LV) over 120 minutes on Days 1 and 15.\n3. Irinotecan 180 mg/m2 over 90 minutes (concurrently with the LV infusion) on Days 1 and 15.\n4. 5-FU 400 mg/m2 bolus on Days 1 and 15.\n5. 5-FU 2400 mg/m2 infusion over 46 hours on Days 1 and 15.', 'otherNumAtRisk': 57, 'deathsNumAtRisk': 57, 'otherNumAffected': 57, 'seriousNumAtRisk': 57, 'deathsNumAffected': 6, 'seriousNumAffected': 17}], 'otherEvents': [{'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 12, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 12, 'numAffected': 8}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 45, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 56, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 60, 'numAffected': 26}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 14, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 23, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 18, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 13, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Influenza-like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Rhinorrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 46, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 32, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 18, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Infusion-related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 25, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Neurotoxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 28, 'numAffected': 16}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 16, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 10, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 7, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 113, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 79, 'numAffected': 33}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 76, 'numAffected': 28}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 81, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 80, 'numAffected': 37}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 51, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 40, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 41, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 30, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 30, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 22, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 21, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 14, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 19, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 10, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 23, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 11, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Gastroesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 6, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Rectal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Salivary hypersecretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Odynophagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hypertransaminasemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 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{'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Liver abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Perihepatic abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Rectal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Median Progress-free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NUFIRI-bev Q1W', 'description': 'Arm A: Study treatment will be administered in 28-day cycles as follows:\n\n1. Bevacizumab 5 mg/kg on Days 1 and 15:\n2. LV 400 mg/m2 (or equivalent levo-LV) over 120 minutes on Days 1, 8, 15, and 22.\n3. Irinotecan 180 mg/m2 over 90 minutes (concurrently with the LV infusion) on Days 1 and 15.\n4. NUC-3373 1500 mg/m2 over 120 minutes on Days 1, 8, 15, and 22.'}, {'id': 'OG001', 'title': 'NUFIRI-bev Q2W', 'description': 'Arm B: Study treatment will be administered in 28-day cycles as follows:\n\n1. Bevacizumab 5 mg/kg on Days 1 and 15:\n2. LV 400 mg/m2 (or equivalent levo-LV) over 120 minutes on Days 1 and 15.\n3. Irinotecan 180 mg/m2 over 90 minutes (concurrently with the LV infusion) on Days 1 and 15.\n4. NUC-3373 1500 mg/m2 over 120 minutes on Days 1 and 15'}, {'id': 'OG002', 'title': 'FOLFIRI-bev Q2W', 'description': 'Arm C: Study treatment will be administered in 28-day cycles as follows:\n\n1. Bevacizumab 5 mg/kg on Days 1 and 15:\n2. LV 400 mg/m2 (or equivalent levo-LV) over 120 minutes on Days 1 and 15.\n3. Irinotecan 180 mg/m2 over 90 minutes (concurrently with the LV infusion) on Days 1 and 15.\n4. 5-FU 400 mg/m2 bolus on Days 1 and 15.\n5. 5-FU 2400 mg/m2 infusion over 46 hours on Days 1 and 15.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.68', 'groupId': 'OG000', 'lowerLimit': '0.03', 'upperLimit': '11.17'}, {'value': '5.52', 'groupId': 'OG001', 'lowerLimit': '0.03', 'upperLimit': '10.84'}, {'value': '9.03', 'groupId': 'OG002', 'lowerLimit': '0.03', 'upperLimit': '15.01'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Assessed from baseline to 30 days after last dose of study drug, up to 16 months', 'description': 'PFS assessed according to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1, defined as the time from randomisation to the first observation of objective tumour progression or death from any cause. Progression was defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in non-target lesions, or the appearance of new lesions.', 'unitOfMeasure': 'Months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients Achieving a Reduction in Tumour Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NUFIRI-bev Q1W', 'description': 'Arm A: Study treatment will be administered in 28-day cycles as follows:\n\n1. Bevacizumab 5 mg/kg on Days 1 and 15:\n2. LV 400 mg/m2 (or equivalent levo-LV) over 120 minutes on Days 1, 8, 15, and 22.\n3. Irinotecan 180 mg/m2 over 90 minutes (concurrently with the LV infusion) on Days 1 and 15.\n4. NUC-3373 1500 mg/m2 over 120 minutes on Days 1, 8, 15, and 22.'}, {'id': 'OG001', 'title': 'NUFIRI-bev Q2W', 'description': 'Arm B: Study treatment will be administered in 28-day cycles as follows:\n\n1. Bevacizumab 5 mg/kg on Days 1 and 15:\n2. LV 400 mg/m2 (or equivalent levo-LV) over 120 minutes on Days 1 and 15.\n3. Irinotecan 180 mg/m2 over 90 minutes (concurrently with the LV infusion) on Days 1 and 15.\n4. NUC-3373 1500 mg/m2 over 120 minutes on Days 1 and 15'}, {'id': 'OG002', 'title': 'FOLFIRI-bev Q2W', 'description': 'Arm C: Study treatment will be administered in 28-day cycles as follows:\n\n1. Bevacizumab 5 mg/kg on Days 1 and 15:\n2. LV 400 mg/m2 (or equivalent levo-LV) over 120 minutes on Days 1 and 15.\n3. Irinotecan 180 mg/m2 over 90 minutes (concurrently with the LV infusion) on Days 1 and 15.\n4. 5-FU 400 mg/m2 bolus on Days 1 and 15.\n5. 5-FU 2400 mg/m2 infusion over 46 hours on Days 1 and 15.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed from baseline to 30 days after last dose of study drug, up to 16 months', 'description': 'Objective response rate, defined as the percentage of patients achieving a complete (CR) or partial response (PR) to treatment. Response was measured by MRI scan and assessed per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria:\n\nCR= disappearance of all target lesions PR= at least a 30% decrease in the sum of the longest diameter of target lesions', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients Achieving Disease Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NUFIRI-bev Q1W', 'description': 'Arm A: Study treatment will be administered in 28-day cycles as follows:\n\n1. Bevacizumab 5 mg/kg on Days 1 and 15:\n2. LV 400 mg/m2 (or equivalent levo-LV) over 120 minutes on Days 1, 8, 15, and 22.\n3. Irinotecan 180 mg/m2 over 90 minutes (concurrently with the LV infusion) on Days 1 and 15.\n4. NUC-3373 1500 mg/m2 over 120 minutes on Days 1, 8, 15, and 22.'}, {'id': 'OG001', 'title': 'NUFIRI-bev Q2W', 'description': 'Arm B: Study treatment will be administered in 28-day cycles as follows:\n\n1. Bevacizumab 5 mg/kg on Days 1 and 15:\n2. LV 400 mg/m2 (or equivalent levo-LV) over 120 minutes on Days 1 and 15.\n3. Irinotecan 180 mg/m2 over 90 minutes (concurrently with the LV infusion) on Days 1 and 15.\n4. NUC-3373 1500 mg/m2 over 120 minutes on Days 1 and 15'}, {'id': 'OG002', 'title': 'FOLFIRI-bev Q2W', 'description': 'Arm C: Study treatment will be administered in 28-day cycles as follows:\n\n1. Bevacizumab 5 mg/kg on Days 1 and 15:\n2. LV 400 mg/m2 (or equivalent levo-LV) over 120 minutes on Days 1 and 15.\n3. Irinotecan 180 mg/m2 over 90 minutes (concurrently with the LV infusion) on Days 1 and 15.\n4. 5-FU 400 mg/m2 bolus on Days 1 and 15.\n5. 5-FU 2400 mg/m2 infusion over 46 hours on Days 1 and 15.'}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed from baseline to 30 days after last dose of study drug, up to 16 months', 'description': 'Disease control rate, defined as the number of patients achieving a response (CR or PR) or stable disease (SD) as their best overall response. Disease control was measured by MRI scan and assessed using Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria:\n\nCR= disappearance of all target lesions PR= at least a 30% decrease in the sum of the longest diameter of target lesions SD= neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'NUFIRI-bev Q1W', 'description': 'Arm A: Study treatment will be administered in 28-day cycles as follows:\n\n1. Bevacizumab 5 mg/kg on Days 1 and 15:\n2. LV 400 mg/m2 (or equivalent levo-LV) over 120 minutes on Days 1, 8, 15, and 22.\n3. Irinotecan 180 mg/m2 over 90 minutes (concurrently with the LV infusion) on Days 1 and 15.\n4. NUC-3373 1500 mg/m2 over 120 minutes on Days 1, 8, 15, and 22.'}, {'id': 'FG001', 'title': 'NUFIRI-bev Q2W', 'description': 'Arm B: Study treatment will be administered in 28-day cycles as follows:\n\n1. Bevacizumab 5 mg/kg on Days 1 and 15:\n2. LV 400 mg/m2 (or equivalent levo-LV) over 120 minutes on Days 1 and 15.\n3. Irinotecan 180 mg/m2 over 90 minutes (concurrently with the LV infusion) on Days 1 and 15.\n4. NUC-3373 1500 mg/m2 over 120 minutes on Days 1 and 15'}, {'id': 'FG002', 'title': 'FOLFIRI-bev Q2W', 'description': 'Arm C: Study treatment will be administered in 28-day cycles as follows:\n\n1. Bevacizumab 5 mg/kg on Days 1 and 15:\n2. LV 400 mg/m2 (or equivalent levo-LV) over 120 minutes on Days 1 and 15.\n3. Irinotecan 180 mg/m2 over 90 minutes (concurrently with the LV infusion) on Days 1 and 15.\n4. 5-FU 400 mg/m2 bolus on Days 1 and 15.\n5. 5-FU 2400 mg/m2 infusion over 46 hours on Days 1 and 15.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '65'}, {'groupId': 'FG002', 'numSubjects': '58'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '32'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '26'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'No longer clinically benefitting', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Sponsor decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Patient non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'A total of 180 patients were randomized between April 2023 and August 2024'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '180', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'NUFIRI-bev Q1W', 'description': 'Arm A: Study treatment will be administered in 28-day cycles as follows:\n\n1. Bevacizumab 5 mg/kg on Days 1 and 15:\n2. LV 400 mg/m2 (or equivalent levo-LV) over 120 minutes on Days 1, 8, 15, and 22.\n3. Irinotecan 180 mg/m2 over 90 minutes (concurrently with the LV infusion) on Days 1 and 15.\n4. NUC-3373 1500 mg/m2 over 120 minutes on Days 1, 8, 15, and 22.'}, {'id': 'BG001', 'title': 'NUFIRI-bev Q2W', 'description': 'Arm B: Study treatment will be administered in 28-day cycles as follows:\n\n1. Bevacizumab 5 mg/kg on Days 1 and 15:\n2. LV 400 mg/m2 (or equivalent levo-LV) over 120 minutes on Days 1 and 15.\n3. Irinotecan 180 mg/m2 over 90 minutes (concurrently with the LV infusion) on Days 1 and 15.\n4. NUC-3373 1500 mg/m2 over 120 minutes on Days 1 and 15'}, {'id': 'BG002', 'title': 'FOLFIRI-bev Q2W', 'description': 'Arm C: Study treatment will be administered in 28-day cycles as follows:\n\n1. Bevacizumab 5 mg/kg on Days 1 and 15:\n2. LV 400 mg/m2 (or equivalent levo-LV) over 120 minutes on Days 1 and 15.\n3. Irinotecan 180 mg/m2 over 90 minutes (concurrently with the LV infusion) on Days 1 and 15.\n4. 5-FU 400 mg/m2 bolus on Days 1 and 15.\n5. 5-FU 2400 mg/m2 infusion over 46 hours on Days 1 and 15.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.0', 'groupId': 'BG000', 'lowerLimit': '38', 'upperLimit': '78'}, {'value': '64.0', 'groupId': 'BG001', 'lowerLimit': '37', 'upperLimit': '79'}, {'value': '65.0', 'groupId': 'BG002', 'lowerLimit': '27', 'upperLimit': '85'}, {'value': '64.0', 'groupId': 'BG003', 'lowerLimit': '27', 'upperLimit': '85'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '108', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'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': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', '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': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '128', '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': '9', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'ECOG performance status', 'classes': [{'categories': [{'title': '0', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '105', 'groupId': 'BG003'}]}, {'title': '1', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '71', 'groupId': 'BG003'}]}, {'title': 'Not reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "The ECOG score describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability (walking, working, etc.). The score runs from 0 to 5, with 0 denoting perfect health and 5 death. Patients with scores of 0 or 1 were eligible for this study:\n\n0 - Asymptomatic. Fully active, able to carry on all predisease activities without restriction\n\n1 - Symptomatic but completely ambulatory. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (e.g., light housework, office work).", 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Stage at initial diagnosis', 'classes': [{'categories': [{'title': 'Stage I (A-C)', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Stage II (A-C)', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}, {'title': 'Stage IIIA', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': 'Stage IIIB', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}]}, {'title': 'Stage IIIC', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}, {'title': 'Stage IV', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '82', 'groupId': 'BG003'}]}, {'title': 'Stage IVA', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}]}, {'title': 'Stage IVB', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}, {'title': 'Stage IVC', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Not reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'CRC is staged using the TNM system and grouped into Stages 0-4 (0-IV), with lower numbers indicating less advanced cancer.\n\nIn Stages 1 and 2 (I and II), the cancer is confined to the bowel and has not spread to the lymph nodes or other organs.\n\nIn Stage 3 (III), the cancer has spread to the lymph nodes but not to other organs.\n\nIn Stage 4 (IV), the cancer has spread to distant parts of the body (e.g., the liver or lungs).\n\nWithin each stage, subcategories show the extent of disease:\n\nA: Least advanced within that stage. B: More advanced than A. C: Most advanced within that stage.', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Primary tumor location', 'classes': [{'categories': [{'title': 'Colon - right side', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}]}, {'title': 'Colon - left side', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '64', 'groupId': 'BG003'}]}, {'title': 'Colon - unknown', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}, {'title': 'Rectum', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Liver metastases', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '126', 'groupId': 'BG003'}]}, {'title': 'No', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of metastatic sites', 'classes': [{'categories': [{'title': '1', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': '2', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}]}, {'title': '3', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}]}, {'title': '4 or more', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}]}, {'title': 'Not reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-02-06', 'size': 24696563, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-08-07T06:54', 'hasProtocol': True}, {'date': '2024-04-17', 'size': 10354854, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-08-07T06:55', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'whyStopped': "A pre-planned initial analysis concluded that the study was unlikely to achieve its primary objective of demonstrating superior progression-free survival. Based on the Steering Committee's recommendation, the Sponsor has closed the study.", 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-08-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-25', 'studyFirstSubmitDate': '2022-12-22', 'resultsFirstSubmitDate': '2025-08-07', 'studyFirstSubmitQcDate': '2023-01-09', 'lastUpdatePostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-08-25', 'studyFirstPostDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-08-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Median Progress-free Survival (PFS)', 'timeFrame': 'Assessed from baseline to 30 days after last dose of study drug, up to 16 months', 'description': 'PFS assessed according to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1, defined as the time from randomisation to the first observation of objective tumour progression or death from any cause. Progression was defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in non-target lesions, or the appearance of new lesions.'}], 'secondaryOutcomes': [{'measure': 'Number of Patients Achieving a Reduction in Tumour Volume', 'timeFrame': 'Assessed from baseline to 30 days after last dose of study drug, up to 16 months', 'description': 'Objective response rate, defined as the percentage of patients achieving a complete (CR) or partial response (PR) to treatment. Response was measured by MRI scan and assessed per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria:\n\nCR= disappearance of all target lesions PR= at least a 30% decrease in the sum of the longest diameter of target lesions'}, {'measure': 'Number of Patients Achieving Disease Control', 'timeFrame': 'Assessed from baseline to 30 days after last dose of study drug, up to 16 months', 'description': 'Disease control rate, defined as the number of patients achieving a response (CR or PR) or stable disease (SD) as their best overall response. Disease control was measured by MRI scan and assessed using Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria:\n\nCR= disappearance of all target lesions PR= at least a 30% decrease in the sum of the longest diameter of target lesions SD= neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Relapsed metastatic adenocarcinoma of colon/rectum', 'NUC-3373', 'Fosifloxuridine nafalbenamide', 'Leucovorin', 'Irinotecan', 'Bevacizumab', 'Antineoplastic agents', 'Chemotherapy', 'Second-line chemotherapy', 'Locally advanced cancer', 'Metastatic cancer', 'Neoplasm', '5-FU'], 'conditions': ['Colorectal Cancer', 'Colorectal Neoplasms', 'Colorectal Adenocarcinoma', 'Colorectal Cancer Metastatic', 'Neoplasm, Colorectal']}, 'descriptionModule': {'briefSummary': 'This is a randomized, open-label, dose/schedule optimization study comparing NUC-3373/leucovorin (LV)/irinotecan plus bevacizumab (NUFIRI-bev) to 5-FU/LV/irinotecan plus bevacizumab (FOLFIRI-bev) for the treatment of patients with unresectable metastatic colorectal cancer.\n\nA total of 171 patients will be randomized 1:1:1 to either NUFIRI-bev on a weekly NUC-3373 schedule, NUFIRI-bev based on an alternate weekly NUC-3373 schedule, or FOLFIRI bev on an alternate weekly schedule. The main objectives are to assess and compare the efficacy and safety of the 3 regimens. Pharmacokinetics will be assessed on the 2 NUFIRI arms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Provision of written informed consent.\n2. Histological or cytological confirmation of colorectal adenocarcinoma (excluding appendiceal and anal canal cancers, as well as signet-ring cell carcinoma) that is unresectable and metastatic.\n3. Measurable disease (as defined by RECIST v1.1).\n4. Received ≥2 months of a first-line fluoropyrimidine and oxaliplatin-containing regimen for metastatic disease or relapsed within 6 months of completing a fluoropyrimidine and oxaliplatin-containing neoadjuvant/adjuvant therapy. Previous treatment with standard of care chemotherapy regimens in combination with molecular targeted therapies (e.g., VEGF and EGFR pathway inhibitors and immuno-oncology agents) is permitted. Previous treatment with maintenance therapy (e.g., capecitabine) is also allowed. Patients who started on a fluoropyrimidine and oxaliplatin-containing regimen in any setting but must discontinue the oxaliplatin due to.toxicity or allergy (and are now unable to receive oxaliplatin) are considered eligible regardless of the number of cycles of oxaliplatin they received.\n5. Known RAS and BRAF status. Patients with wild-type RAS tumours must have received prior treatment with an EGFR inhibitor, unless this was not standard of care according to relevant region-specific treatment recommendations.\n6. Known UGT1A1 status, or patient consents to UGT1A1 status testing if unknown.\n7. Known DPD activity status, or patient consents to DPD status testing if unknown. See exclusion criterion 1.\n8. Age ≥18 years.\n9. Minimum life expectancy of ≥12 weeks.\n10. Eastern Cooperative Oncology Group (ECOG) Performance status 0 or 1.\n11. Adequate bone marrow function as defined by: absolute neutrophil count (ANC) ≥1.5 × 109/L, platelet count ≥100 × 109/L, and haemoglobin ≥9 g/dL. Patients with benign neutropenia may be discussed on a case-by-case basis with the medical monitor.\n12. Adequate liver function, as defined by: serum total bilirubin ≤1.5 × ULN), AST and ALT ≤2.5 × ULN (or ≤5 × ULN if liver metastases are present).\n13. Adequate renal function assessed as serum creatinine \\<1.5 × ULN and glomerular filtration rate ≥50 mL/min (calculated by the Cockcroft-Gault method).\n14. Serum albumin ≥3 g/dL.\n15. Ability to comply with protocol requirements.\n16. Female patients of child-bearing potential must have a negative serum pregnancy test within 7 days prior to the first study drug administration. This criterion does not apply to patients who have had a previous hysterectomy or bilateral oophorectomy. Male patients and female patients of child-bearing potential must agree to practice true abstinence (defined in Section 10.3.1) or to use two forms of contraception, one of which must be highly effective. These forms of contraception must be used from the time of signing consent, throughout the treatment period, and for 6 months following the last dose of any study medication. Oral or injectable contraceptive agents cannot be the sole method of contraception\n17. Patients must have been advised to take measures to avoid or minimize exposure of the skin and eyes to UV light, including avoiding sunbathing and solarium use, for the duration of study participation and for a period of 4 weeks following the last dose of study medication\n\nExclusion Criteria:\n\n1. History of hypersensitivity or current contra-indications to 5-FU, FUDR, or capecitabine.\n2. History of hypersensitivity or current contra-indication to any of the combination agents required for the study.\n3. History of allergic reactions attributed to components of the NUC-3373 drug product formulation.\n4. History of hypersensitivity to Chinese Hamster Ovary (CHO) cell products or other recombinant human or humanised antibodies.\n5. History of or known central nervous system or leptomeningeal metastases.\n6. Symptomatic ascites, ascites currently requiring drainage procedures or ascites requiring drainage over the prior 3 months.\n7. Mutant BRAF V600E status.\n8. MSI high or dMMR.\n9. Prior treatment with irinotecan.\n10. Chemotherapy, hormonal therapy, radiotherapy (other than a short cycle of palliative radiotherapy \\[e.g., for bone pain\\]\\*), immunotherapy, biological agents, or exposure to another investigational agent within 21 days (or four times the half-life for molecular targeted agents, whichever is shorter) of first administration of study treatment:\n11. Residual toxicities from prior chemotherapy or radiotherapy which have not regressed to Grade ≤1 severity (CTCAE v5.0), except for alopecia and residual Grade 2 neuropathy.\n12. History of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, surgically excised or potentially curatively treated ductal carcinoma in situ of the breast, or low-grade prostate cancer or patients after prostatectomy. Patients with previous invasive cancers are eligible if treatment was completed \\>3 years prior to initiating the current study treatment, and the patient has had no evidence or recurrence since then.\n13. Presence of an active bacterial or viral infection (including SARS-CoV-2, Herpes Zoster, Varicella Zoster or chickenpox), known Human Immunodeficiency Virus (HIV) positive or known active hepatitis B or C.\n14. Presence of any uncontrolled concurrent serious illness, medical condition or other medical history, including laboratory results, which, in the Investigator's opinion, would be likely to interfere with the patient's ability to participate in the study or with the interpretation of the results (refer to protocol for further details).\n15. Any condition that, in the judgment of the Investigator, may affect the patient's ability to provide informed consent and undergo study procedures.\n16. Patients with a history of haemoptysis (1/2 teaspoon or more of red blood) within 6 months prior to enrolment.\n17. Wound healing complications or surgery within 28 days of starting bevacizumab (wound healing must have been fully completed before starting bevacizumab). Investigators may allow patients to initiate treatment with the other study drugs (i.e., NUC-3373/5-FU, LV and irinotecan) on C1D1 but withhold bevacizumab for at least 15 days, but no longer than 28 days, to allow completion of wound healing in patients who would otherwise be eligible for the study, in line with standard local practice and after discussion with the Medical Monitor. Patients who have not received bevacizumab by C2D1 must be replaced.\n18. Unhealed wound, active gastric or duodenal ulcer, or bone fracture.\n19. Serious thromboembolic event in the 6 months before inclusion.\n20. Patients with a history of haemorrhage within 6 months prior to enrolment.\n21. Known inherited or acquired bleeding disorders.\n22. Red blood cell (RBC) transfusion dependence, defined as requiring more than 2 units of packed RBC transfusions during the 4-week period prior to screening.\n23. Uncontrolled hypertension.\n24. Severe proteinuria or nephrotic syndrome.\n25. Acute intestinal obstruction or sub-obstruction, history of inflammatory intestinal disease or extended resection of the small intestine. Presence of a colic prosthesis.\n26. History of abdominal fistulas, trachea-oesophageal fistulas, any other Grade 4 gastrointestinal perforations, non-gastrointestinal fistulas, or intra-abdominal abscesses 6 months prior to screening.\n27. Currently pregnant, lactating or breastfeeding.\n28. Required concomitant use of brivudine, sorivudine and analogues.\n29. Required concomitant use of St John's Wort.\n30. Required concomitant use of drugs known to prolong QT/QTc interval.\n31. Required concomitant use of strong CYP3A4 inducers or strong CYP3A4 inhibitors. The use of strong CYP3A4 inducers within 2 weeks of first receipt of study drug or the use of strong CYP3A4 inhibitors within 1 week of first receipt of study drug is also excluded."}, 'identificationModule': {'nctId': 'NCT05678257', 'briefTitle': 'A Study of NUC-3373 in Combination With Other Agents in Patients With Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'NuCana plc'}, 'officialTitle': 'A Randomised, Open-label, Phase II, Dose/Schedule Optimisation Study of NUC-3373/Leucovorin/Irinotecan Plus Bevacizumab (NUFIRI-bev) Versus 5-FU/Leucovorin/Irinotecan Plus Bevacizumab (FOLFIRI-bev) for the Treatment of Patients With Previously Treated Unresectable Metastatic Colorectal Cancer', 'orgStudyIdInfo': {'id': 'NuTide:323'}, 'secondaryIdInfos': [{'id': '2022-001459-17', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NUFIRI-bev on a Q1W NUC-3373 schedule', 'description': 'Arm A: Study treatment will be administered in 28-day cycles as follows:\n\n1. Bevacizumab 5 mg/kg on Days 1 and 15:\n\n * 90 minutes for the first dose\n * 60 minutes for the second dose (if first dose is tolerated)\n * 30 minutes for subsequent doses (if second dose is tolerated)\n2. LV 400 mg/m2 (or equivalent levo-LV) over 120 minutes on Days 1, 8, 15, and 22.\n3. Irinotecan 180 mg/m2 over 90 minutes (concurrently with the LV infusion) on Days 1 and 15.\n4. NUC-3373 1500 mg/m2 over 120 minutes on Days 1, 8, 15, and 22.', 'interventionNames': ['Drug: Fosifloxuridine Nafalbenamide', 'Drug: Leucovorin', 'Drug: Irinotecan', 'Biological: Bevacizumab']}, {'type': 'EXPERIMENTAL', 'label': 'NUFIRI-bev on a Q2W NUC-3373 schedule', 'description': 'Arm B: Study treatment will be administered in 28-day cycles as follows:\n\n1. Bevacizumab 5 mg/kg on Days 1 and 15:\n\n * 90 minutes for the first dose\n * 60 minutes for the second dose (if first dose is tolerated)\n * 30 minutes for subsequent doses (if second dose is tolerated)\n2. LV 400 mg/m2 (or equivalent levo-LV) over 120 minutes on Days 1 and 15.\n3. Irinotecan 180 mg/m2 over 90 minutes (concurrently with the LV infusion) on Days 1 and 15.\n4. NUC-3373 1500 mg/m2 over 120 minutes on Days 1 and 15.', 'interventionNames': ['Drug: Fosifloxuridine Nafalbenamide', 'Drug: Leucovorin', 'Drug: Irinotecan', 'Biological: Bevacizumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'FOLFIRI-bev on a Q2W schedule', 'description': 'Arm C: Study treatment will be administered in 28-day cycles as follows:\n\n1. Bevacizumab 5 mg/kg on Days 1 and 15:\n\n * 90 minutes for the first dose\n * 60 minutes for the second dose (if first dose is tolerated)\n * 30 minutes for subsequent doses (if second dose is tolerated)\n2. LV 400 mg/m2 (or equivalent levo-LV) over 120 minutes on Days 1 and 15.\n3. Irinotecan 180 mg/m2 over 90 minutes (concurrently with the LV infusion) on Days 1 and 15.\n4. 5-FU 400 mg/m2 bolus on Days 1 and 15.\n5. 5-FU 2400 mg/m2 infusion over 46 hours on Days 1 and 15.', 'interventionNames': ['Drug: Leucovorin', 'Drug: Irinotecan', 'Biological: Bevacizumab', 'Drug: 5-FU']}], 'interventions': [{'name': 'Fosifloxuridine Nafalbenamide', 'type': 'DRUG', 'otherNames': ['NUC-3373', 'Nucleotide analogue'], 'description': 'Intravenous infusion', 'armGroupLabels': ['NUFIRI-bev on a Q1W NUC-3373 schedule', 'NUFIRI-bev on a Q2W NUC-3373 schedule']}, {'name': 'Leucovorin', 'type': 'DRUG', 'otherNames': ['Folinic acid', 'LV'], 'description': 'Intravenous infusion', 'armGroupLabels': ['FOLFIRI-bev on a Q2W schedule', 'NUFIRI-bev on a Q1W NUC-3373 schedule', 'NUFIRI-bev on a Q2W NUC-3373 schedule']}, {'name': 'Irinotecan', 'type': 'DRUG', 'otherNames': ['Campto', 'Camptosar'], 'description': 'Intravenous infusion', 'armGroupLabels': ['FOLFIRI-bev on a Q2W schedule', 'NUFIRI-bev on a Q1W NUC-3373 schedule', 'NUFIRI-bev on a Q2W NUC-3373 schedule']}, {'name': 'Bevacizumab', 'type': 'BIOLOGICAL', 'otherNames': ['Avastin', 'Zirabev'], 'description': 'Intravenous infusion', 'armGroupLabels': ['FOLFIRI-bev on a Q2W schedule', 'NUFIRI-bev on a Q1W NUC-3373 schedule', 'NUFIRI-bev on a Q2W NUC-3373 schedule']}, {'name': '5-FU', 'type': 'DRUG', 'otherNames': ['5FU', '5-fluorouracil', 'Fluorouracil'], 'description': 'Intravenous infusion', 'armGroupLabels': ['FOLFIRI-bev on a Q2W schedule']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19713', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'Helen F. Graham Cancer Center', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown University Medical Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida Health Medical Oncology - Davis Cancer Pavilion', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa Hospitals and Clinics', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '67214', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Norton Cancer Institute', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'University of Massachusetts Worcester', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Barbara Ann Karmanos Cancer Institute', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '07960', 'city': 'Morristown', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Morristown Medical Center', 'geoPoint': {'lat': 40.79677, 'lon': -74.48154}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Christ Hospital Cancer Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology - Baylor Charles A. 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