Clinical trial · Interventional
Relationship Between Pharmacokinetics and Safety of Vismodegib - OPTIVISMO-1
Study of the Relationship Between the Pharmacokinetics of Vismodegib and Safety Data: a Pilot Study to Therapeutic Optimization in Patients With Basal Cell Carcinoma - OPTIVISMO-1
- 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)
Vismodegib (ERIVEDGE®) at the standard dose of 150 mg/day orally is indicated for the treatment of advanced Basal Cell Carcinoma (BCC) and is associated with many adverse effects. Cramps, alopecia, dysgeusia, weight loss and others observed in clinical practice, compromize compliance and often lead to treatment discontinuation. Currently, it is the only drug available in this indication. Our main objective is to assess the relationship between plasma concentrations of vismodegib, and the occurrence of adverse effects within 6 months of inclusion in the study.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Basal Cell Carcinoma | Basal Cell Carcinoma | CURATED_BROADER | 0.78 |
| Metastatic Basal Cell Carcinoma | Basal Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Treatment with vismodegib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients with BCC and annexial carcinoma
- description
- Patients with BCC and annexial carcinoma histologically proven under treatment or new patients under vismodegib
- interventionNames
- Drug: Treatment with vismodegib
Primary outcomes (1)
- measure
- Serious side effects (grade 2 or more) during the clinical response follow-up to vismodegib
- timeFrame
- Occurrence from inclusion to 6 months visit
- description
- Patients already on vismodegib will be monitored at inclusion and for 6 months (M0, M1, M2, M3, M4, M5). New patients will be monitored from the end of the first month after inclusion and during 6 months (M1, M2, M3, M4, M5, M6)
Secondary outcomes (2)
- measure
- Relationship between the plasma concentrations of free and/or total vismodegib, and covariates
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with BCC and annexial carcinoma histologically proven under treatment or new patients under vismodegib or patients who restarted treatment * 18 years-old or older * Complete medical record * Members or beneficiaries of a social security system, * Patients must have given informed consent, free and written. Exclusion Criteria: * Patients with or without BCC and not treated with vismodegib * BCC patients who stopped treatment with vismodegib due to non-response or progression on treatment * Patients under 18 years-old * Patients whose medical record is incomplete * Unaffiliated subjects or not beneficiaries of a security system social, * Patients who have not been informed and have not given their consent, free and written, * Pregnant and childbearing women without effective contraceptive method * Patients with confusional state
References
Publications (0)
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