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

Stage III or Stage IV Metastatic Melanoma That Has Not Been Previously Treated With a Selective BRAF Inhibitor Clinical Trial

Official title: A Phase 1b Open Label, Dose Escalation Study to Assess Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of PLX3397 in Combination With Vemurafenib in V600-mutated BRAF Unresectable or Metastatic Melanoma

Status Terminated

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Melanoma
• Stage III or Stage IV Metastatic Melanoma That Has Not Been Previously Treated With a Selective BRAF Inhibitor
• V600-mutated BRAF Metastatic Melanoma
• V600-mutated BRAF Unresectable Melanoma

• NCT number: NCT01826448
• Study type: Interventional
• Source: Daiichi Sankyo, Inc.
• Status: Terminated
• Phase: Phase 1
• Start date: November 5, 2013
• Completion date: September 22, 2014