Relationship Between Pharmacokinetics and Safety of Vismodegib - OPTIVISMO-1

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.

Timeline

Start

2018-09-03

Primary completion

2021-05-12

Completion

2021-05-12

Drugs

Indications