Conditions: Multiple Myeloma, Neoplasms
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 208
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Participants with NSCLC will be treated with vemurafenib monotherapy. arm 2: Participants with ovarian cancer will be treated with vemurafenib monotherapy. arm 3: Participants with colorectal cancer will be treated with vemurafenib monotherapy. arm 4: Participants with colorectal cancer will be treated with vemurafenib and cetuximab combination therapy. arm 5: Participants with cholangiocarcinoma will be treated with vemurafenib monotherapy. arm 6: Participants with multiple myeloma will be treated with vemurafenib monotherapy. arm 7: Participants with Erdheim-Chester disease (ECD), Langerhans cell histiocytosis (LCH), anaplastic thyroid cancer, advanced stage astrocytoma, early stage astrocytoma and other BRAF V600-positive tumors will be treated with vemurafenib monotherapy. Subcohorts will be analyzed separately if 7 or more participants are enrolled for each indication.

Interventions: intervention 1: cetuximab intervention 2: vemurafenib intervention 3: vemurafenib
Intervention descriptions: intervention 1: Escalating doses administered on Day 1 and then once weekly by intravenous infusion. intervention 2: Escalating doses given orally twice a day starting on Day 2 intervention 3: 960 mg vemurafenib orally twice a day until disease progression, unacceptable toxicity, or withdrawal of consent.

Protocol document: