BRIM-P: A Study of Vemurafenib in Pediatric Patients With Stage IIIC or Stage IV Melanoma Harboring BRAFV600 Mutations
Status:
Terminated
Trial end date:
2015-12-01
Target enrollment:
Participant gender:
Summary
This open-label, multicenter. single arm Phase I dose-escalation study with efficacy tail
extension will evaluate the maximum tolerated dose/recommended dose, the safety and efficacy
of vemurafenib (RO5185426) in pediatric participants (aged 12 through 17) with newly
diagnosed or recurrent surgically incurable and unresectable Stage IIIC or Stage IV melanoma
harboring BRAFV600 mutations. Participants will receive vemurafenib orally twice daily until
disease progression or unacceptable toxicity occurs.