drugset / Trial / NCT01826448

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

NCT01826448

Phase 1 Terminated 13 enrolled Daiichi Sankyo Plexxikon · collab
Non-randomizedSingle-groupOpen-labelTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Pexidartinib Small molecule 800 mg
Subject Pexidartinib Small molecule 1000 mg
Subject Vemurafenib Small molecule 720 mg
Subject Vemurafenib Small molecule 960 mg

Indications