A Study of Vemurafenib in Participants With BRAF V600 Mutation-Positive Cancers
Condition: Multiple Myeloma, Neoplasms
MeSH terms: Multiple Myeloma
Intervention: cetuximab; vemurafenib; vemurafenib
Intervention description: 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.
Intervention MeSH terms: Cetuximab; Vemurafenib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 208.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

          -  Must have recovered from all side effects of their most recent systemic or local
             treatment

          -  Adequate hematological, renal and liver function

        For solid tumors only:

          -  Histologically confirmed cancers (excluding melanoma and papillary thyroid cancer)
             with a BRAF V600 mutation and that are resistant to standard therapy or for which
             standard or curative therapy does not exist

          -  Measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST)

        For multiple myeloma only:

          -  Confirmed diagnosis of multiple myeloma with a BRAF V600 mutation

          -  Must have received at least one prior systemic therapy for the treatment of multiple
             myeloma

          -  Treated with local radiotherapy

          -  Must have relapsed and/or refractory multiple myeloma with measurable disease

        Exclusion Criteria:

          -  Melanoma, papillary thyroid cancer or hematological malignancies (with the exception
             of multiple myeloma)

          -  Uncontrolled concurrent malignancy

          -  Multiple myeloma: solitary bone or solitary extramedullary plasmacytoma as the only
             evidence of plasma cell dyscrasia

          -  Active or untreated central nervous system (CNS) metastases

          -  History of or known carcinomatous meningitis

          -  Concurrent administration of any anti-cancer therapies other than those administered
             in this study

          -  Other severe, acute, or chronic medical or psychiatric condition or laboratory
             abnormality that would, in the investigator's opinion, contraindicate participation in
             this study