drugset / Trial / NCT01781026

Phase 2 Study of Neoadjuvant Vemurafenib in Melanoma Patients With Untreated Brain Metastases

NCT01781026

Phase 2 Completed 2 enrolled Yale University Genentech, Inc. · collab
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this trial is to study the activity of vemurafenib in untreated melanoma brain metastases harboring B-Raf proto-oncogene, serine/threonine kinase (BRAF) mutations that are not amenable to stereotactic radiosurgery based on size, number of lesions or location, to measure cerebrospinal fluid (CSF) levels of vemurafenib as an indicator of central nervous system penetrance and to measure levels of vemurafenib in normal brain tissue and brain metastases in those in whom surgical management is feasible.

Timeline

Start
2013-04
Primary completion
2014-06
Completion
2014-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Vemurafenib Small molecule 960 mg Oral

Indications