A Phase 1b Open Label, Dose Escalation Study of PLX3397 in Combination With Vemurafenib in V600-mutated BRAF Melanoma

Summary

The purpose of this research study is to test the safety of an investigational new drug called PLX3397 when used in combination with Vemurafenib (Zelboraf™) at different dose levels. Vemurafenib has been approved by the United States Food and Drug Administration (FDA)/European Medicines Agency (EMA) for the treatment of a specific category of unresectable or metastatic melanoma.

Timeline

Start

2013-11-05

Primary completion

2014-09-22

Completion

2014-09-22

Outcome

Outcome not reported

Stopped: “No activity was observed. BRAFi-naïve participants should have received triple combination treatment (including MEK inhibitor). Continuation was not justified.”

Drugs

Indications