Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2026-02-06 @ 1:01 PM
Study NCT ID:
NCT04066504
Status:
COMPLETED
Last Update Posted:
2025-06-24
First Post:
2019-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-authorization Safety Study on the Long Term Safety of Sonidegib in Patients With Locally Advanced Cell Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['France']}, 'conditionBrowseModule': {'meshes': [{'id': 'D002280', 'term': 'Carcinoma, Basal Cell'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018295', 'term': 'Neoplasms, Basal Cell'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C561435', 'term': 'sonidegib'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 323}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-23', 'studyFirstSubmitDate': '2019-08-22', 'studyFirstSubmitQcDate': '2019-08-22', 'lastUpdatePostDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients with AEs/SAEs', 'timeFrame': '3 years', 'description': 'including on-treatment deaths and discontinuation due to AEs/SAEs'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients with AEs of special interest (AESI) or populations', 'timeFrame': '3 years', 'description': 'in patients with: relevant polymorphism, ≥65 yrs, hepatic or renal impairment, female patients with child bearing potential using anticonceptives, anemia (hemoglobin \\<9 g/dL), recent myocardial ischemia or cardiac failure, concomitant medications with known risk of creatine kinase elevation'}]}, 'conditionsModule': {'keywords': ['locally advanced basal cell carcinoma', 'laBCC'], 'conditions': ['Basal Cell Carcinoma']}, 'referencesModule': {'references': [{'pmid': '39538176', 'type': 'DERIVED', 'citation': 'Gutzmer R, Leiter U, Mohr P, Kahler KC, Ascierto PA, Scalvenzi M, Peris K, Perez-Pastor GM, Fernandez-de-Misa R, Botella-Estrada R, Hunger RE, Martelli S, Guneli N, Arntz R, Hauschild A. Interim analysis of the multinational, post-authorization safety study (NISSO) to assess the long-term safety of sonidegib in patients with locally advanced basal cell carcinoma. BMC Cancer. 2024 Nov 14;24(1):1401. doi: 10.1186/s12885-024-13101-z.'}]}, 'descriptionModule': {'briefSummary': 'Collect real world safety data on the use of sonidegib in adult patients with laBCC. Document major safety parameters such as on treatment deaths, adverse events (AEs)/ serious adverse events (SAEs) and discontinuation secondary to AEs.', 'detailedDescription': 'This is a non-interventional, multinational, multi-center post-authorization safety study (PASS), to assess the safety of sonidegib administered in routine clinical practice in patients with laBCC who are not amendable to curative surgery or radiation therapy. This study is observational in nature and does not impose a therapy protocol, diagnostic/therapeutic interventions or a specific visit schedule. For this study, each enrolled patient will be followed up for 3 years after enrollment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with laBCC undergoing treatment with sonidegib.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent or equivalent document (e.g., written information) as per country regulation\n* Patients aged 18 years or older with a diagnosis of laBCC who are not amenable to curative surgery or radiation therapy\n* Patients must be treated with sonidegib 200 mg orally taken once daily (dose modifications according to the approved local country prescribing information are permitted)\n* Sonidegib treatment must be started either at the first visit for this study or prior to study entry.\n\nExclusion Criteria:\n\n* Patients treated with any hedgehog pathway inhibitor besides sonidegib within 3 months prior to study entry\n* Patients currently enrolled in an interventional clinical trial\n* Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of the Summary of Product Characteristics (SmPC)\n* Pregnancy and breast-feeding\n* Women of childbearing potential who do not comply with the Odomzo Pregnancy Prevention Programme (as defined in sections 4.4 and 4.6 of the approved SmPC).\n* Male patients who are unable to follow or comply with the required contraception measures (as defined in sections 4.4 and 4.6 of the approved SmPC).'}, 'identificationModule': {'nctId': 'NCT04066504', 'acronym': 'NISSO', 'briefTitle': 'Post-authorization Safety Study on the Long Term Safety of Sonidegib in Patients With Locally Advanced Cell Carcinoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sun Pharmaceutical Industries Limited'}, 'officialTitle': 'A Non-interventional, Multi-national, Multi-center Post-authorization Safety Study (PASS) to Assess the Long Term Safety and Tolerability of Odomzo (Sonidegib) Administered in Patients With Locally Advanced Cell Carcinoma (laBCC)', 'orgStudyIdInfo': {'id': 'CLDE225A2404'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Sonidegib', 'description': 'Patients with laBCC undergoing sonidegib treatment in routine clinical practice', 'interventionNames': ['Drug: sonidegib']}], 'interventions': [{'name': 'sonidegib', 'type': 'DRUG', 'otherNames': ['LDE225'], 'description': 'Sonidegib 200 mg orally taken once daily (dose modifications according to the approved local country prescribing information are permitted)', 'armGroupLabels': ['Sonidegib']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bochum', 'country': 'Germany', 'facility': 'Katholisches Klinikum Bochum St. Josef-Hospital', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'city': 'Buxtehude', 'country': 'Germany', 'facility': 'Elbe Kliniken Stade - Buxtehude GmbH', 'geoPoint': {'lat': 53.46994, 'lon': 9.68968}}, {'zip': '64297', 'city': 'Darmstadt', 'country': 'Germany', 'facility': 'Klinikum Darmstadt GmbH', 'geoPoint': {'lat': 49.87167, 'lon': 8.65027}}, {'zip': '1307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Universitätsklinik Carl Gustav Carus der Technischen Universität Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '99089', 'city': 'Erfurt', 'country': 'Germany', 'facility': 'Helios Klinikum', 'geoPoint': {'lat': 50.97734, 'lon': 11.03536}}, {'city': 'Essen', 'country': 'Germany', 'facility': 'Universitaetsklinikum Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '79104', 'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': 'Universitätsklinikum Freiburg', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': '07548', 'city': 'Gera', 'country': 'Germany', 'facility': 'SRH Wald-Klinikum', 'geoPoint': {'lat': 50.88029, 'lon': 12.08187}}, {'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Universitätsklinikum Hamburg-Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': "'30625", 'city': 'Hanover', 'country': 'Germany', 'facility': 'Medizinische Hochschule Hannover', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'city': 'Kiel', 'country': 'Germany', 'facility': 'Universitaets-Hautklinik Kiel', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'city': 'Ludwigshafen', 'country': 'Germany', 'facility': 'Klinikum Ludwigshafen gGmbH', 'geoPoint': {'lat': 47.81663, 'lon': 9.06138}}, {'city': 'Lübeck', 'country': 'Germany', 'facility': 'Universitaetsklinikum Schleswig-Holstein', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}, {'zip': '39120', 'city': 'Magdeburg', 'country': 'Germany', 'facility': 'Universitätsklinik Magdeburg', 'geoPoint': {'lat': 52.13129, 'lon': 11.63189}}, {'zip': '32429', 'city': 'Minden', 'country': 'Germany', 'facility': 'Johannes Wesling Klinikum Minden', 'geoPoint': {'lat': 52.28953, 'lon': 8.91455}}, {'zip': '80802', 'city': 'München', 'country': 'Germany', 'facility': 'Klinikum rechts der Isar', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '48157', 'city': 'Münster', 'country': 'Germany', 'facility': 'Fachklinik Muenster-Hornheide', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': '46045', 'city': 'Oberhausen', 'country': 'Germany', 'facility': 'Helios St. Elisabeth Klinik', 'geoPoint': {'lat': 51.47805, 'lon': 6.8625}}, {'zip': '06484', 'city': 'Quedlinburg', 'country': 'Germany', 'facility': 'Harzklinikum Dorothea Christiane Erxleben GmbH', 'geoPoint': {'lat': 51.78843, 'lon': 11.15006}}, {'zip': '93053', 'city': 'Regensburg', 'country': 'Germany', 'facility': 'Universitätsklinikum Regensburg', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}, {'city': 'Tübingen', 'country': 'Germany', 'facility': 'Universitaetsklinikum Tuebingen', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'zip': '89081', 'city': 'Ulm', 'country': 'Germany', 'facility': 'Universitätsklinikum Ulm', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}, {'city': 'Bari', 'country': 'Italy', 'facility': 'I.R.C.C.S Istituto Tumori "Giovanni Paolo II"', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'city': 'Brescia', 'country': 'Italy', 'facility': 'ASST Spedali Civili di Brescia', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'city': 'Florence', 'country': 'Italy', 'facility': 'Azienda Toscana Centro - Università di Firenze', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '16132', 'city': 'Genova', 'country': 'Italy', 'facility': 'Ospedale Policlinico San Martino', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'city': 'L’Aquila', 'country': 'Italy', 'facility': "ASL1 Avezzano-Sulmona-L'Aquila", 'geoPoint': {'lat': 42.35055, 'lon': 13.39954}}, {'zip': '47014', 'city': 'Meldola', 'country': 'Italy', 'facility': 'Ist. Scien. Romagnolo per lo Studio e la Cura dei Tumori - IRST', 'geoPoint': {'lat': 44.12775, 'lon': 12.0626}}, {'zip': '20133', 'city': 'Milan', 'country': 'Italy', 'facility': 'Forndazione I.R.C.C.S. Istituto nazionale dei tumori', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '80131', 'city': 'Napoli', 'country': 'Italy', 'facility': 'Istituto Tumori Napoli Fondazione G. 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