NCT01524978

A Study of Vemurafenib in Participants With BRAF V600 Mutation-Positive Cancers

An Open-label, Phase II Study of Vemurafenib in Patients With BRAF V600 Mutation-positive Cancers

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 208 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

This open-label, multi-center study will assess the efficacy and safety of vemurafenib in participants with BRAF V600 mutation-positive cancers (solid tumors and multiple myeloma, except melanoma and papillary thyroid cancer) and for whom vemurafenib is deemed the best treatment option in the opinion of the investigator. Participants will receive twice daily oral doses of 960 mg vemurafenib until disease progression, unacceptable toxicity, or withdrawal of consent. The safety and efficacy of vemurafenib in combination with cetuximab in a subset of participants with colorectal cancer will also be assessed.

Conditions

• Multiple Myeloma, Neoplasms

Interventions

Type	Name	Description
DRUG	cetuximab	Escalating doses administered on Day 1 and then once weekly by intravenous infusion.
DRUG	vemurafenib	Escalating doses given orally twice a day starting on Day 2
DRUG	vemurafenib	960 mg vemurafenib orally twice a day until disease progression, unacceptable toxicity, or withdrawal of consent.

Timeline

• Start date: 2012-04-12
• Primary completion: 2016-10-28
• Completion: 2016-10-28
• First posted: 2012-02-02
• Last updated: 2017-11-20
• Results posted: 2017-11-20

Locations

34 sites across 6 countries: United States, China, France, Germany, Spain, United Kingdom

Regulatory

• FDA-regulated drug study