drugset / Trial / NCT01767623

A Study of The Impact of Severe Hepatic Impairment on the Pharmacokinetics and Safety of Vemurafenib in BRAF V600 Mutation-Positive Cancer Participants

NCT01767623

Phase 1 Completed 8 enrolled Hoffmann-La Roche
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This open-label, Phase I study will evaluate the impact of severe hepatic impairment on the pharmacokinetics and safety of vemurafenib in participants with BRAF V600 mutation positive cancer. Participants will receive vemurafenib 960 milligrams (mg) (normal hepatic function) or 720 mg (severe hepatic impairment) orally twice daily (BID) on Days 1 to 20 (morning dose) and from Day 27 onward until disease progression or unacceptable toxicity occurs.

Timeline

Start
2013-08-20
Primary completion
2017-04-20
Completion
2017-04-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Vemurafenib Small molecule 720 mg Oral
Subject Vemurafenib Small molecule 960 mg Oral

Indications