Relationship Between Pharmacokinetics and Safety of Vismodegib - OPTIVISMO-1

• Status: Recruiting
• Trial end date: 2021-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Bordeaux

Criteria

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