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

Phase 2
18 Years
Open (Enrolling)
Multiple Myeloma, Neoplasms

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Trial Information

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

Inclusion Criteria:

- Adult patients, >/=18 years of age

- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

- Must have recovered from all side effects of their most recent systemic or local

- 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

- Patients must have received at least one prior systemic therapy for the treatment of
multiple myeloma

- Patients treated with local radiotherapy

- Patients must have relapsed and/or refractory multiple myeloma with measurable

Exclusion Criteria:

- Melanoma, papillary thyroid cancer or hematological malignancies (with the exception
of multiple myeloma)

- Uncontrolled concurrent malignancy

- Active or untreated CNS metastases

- History of or known carcinomatous meningitis

- Concurrent administration of any anti-cancer therapies other than those administered
in this study

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor Response Rate

Outcome Time Frame:

Week 8

Safety Issue:


Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche


United States: Food and Drug Administration

Study ID:




Start Date:

April 2012

Completion Date:

December 2015

Related Keywords:

  • Multiple Myeloma, Neoplasms
  • Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



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