At a glance
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An Open-label, Phase II Study of Vemurafenib in Patients With BRAF V600 Mutation-positive Cancers
In Brief
A Phase 2 clinical trial evaluating cetuximab and vemurafenib for Multiple Myeloma, Neoplasms. Completed, enrolled 208 participants across 34 sites in 6 countries.
Detailed 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.
Study Details
Timeline
Interventions
Escalating doses administered on Day 1 and then once weekly by intravenous infusion.
Escalating doses given orally twice a day starting on Day 2
960 mg vemurafenib orally twice a day until disease progression, unacceptable toxicity, or withdrawal of consent.