NCT01826448

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	PLX3397
DRUG	vemurafenib

Timeline

• Start date: 2013-11-05
• Primary completion: 2014-09-22
• Completion: 2014-09-22
• First posted: 2013-04-08
• Last updated: 2020-05-28
• Results posted: 2020-05-28

Locations

6 sites across 3 countries: United States, France, Germany