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

Status: Recruiting
Diagnosis: Gastrointestinal Malignancies, GYN: Ovarian, Fallopian, Peritoneal Cancer, GYN: Cervical Cancer, GYN: Endometrial/Uterine Cancer, Colorectal Cancer
NCT ID: NCT01524978 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-097


This open-label, multi-center study will assess the efficacy and safety of vemurafenib in patients 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. Patients will receive twice daily oral doses of 960 mg vemurafenib until disease progression, unacceptable toxicity, or withdrawal of consent.


Conducting Institutions:
Massachusetts General Hospital, Beth-Israel Deaconess Medical Center, Dana-Farber Cancer Institute

Overall PI:
Jason Faris, MD, Massachusetts General Hospital

Site-responsible Investigators:
Daniel Cho, MD, Beth Israel Deaconess Medical Center
Ursula Matulonis, MD, Dana-Farber Cancer Institute

Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060
Dana-Farber Cancer Institute: Christin Whalen, 617-582-7738, cwhalen@partners.org

Eligibility Criteria

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 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 - 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 disease 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
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