Clinical trial · Observational
Post-authorization Safety Study on the Long Term Safety of Sonidegib in Patients With Locally Advanced Cell Carcinoma
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)
NCT04066504CI-TRIAL-00105779NISSOcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Basal Cell Carcinoma | Basal Cell Carcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| sonidegib | Drug | Sonidegib | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Sonidegib
- description
- Patients with laBCC undergoing sonidegib treatment in routine clinical practice
- interventionNames
- Drug: sonidegib
Primary outcomes (1)
- measure
- Proportion of patients with AEs/SAEs
- timeFrame
- 3 years
- description
- including on-treatment deaths and discontinuation due to AEs/SAEs
Secondary outcomes (1)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent or equivalent document (e.g., written information) as per country regulation * Patients aged 18 years or older with a diagnosis of laBCC who are not amenable to curative surgery or radiation therapy * Patients must be treated with sonidegib 200 mg orally taken once daily (dose modifications according to the approved local country prescribing information are permitted) * Sonidegib treatment must be started either at the first visit for this study or prior to study entry. Exclusion Criteria: * Patients treated with any hedgehog pathway inhibitor besides sonidegib within 3 months prior to study entry * Patients currently enrolled in an interventional clinical trial * Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of the Summary of Product Characteristics (SmPC) * Pregnancy and breast-feeding * 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). * 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).
References
Publications (1)
- DERIVEDGutzmer 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. PMID 39538176