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A Study of Vemurafenib in Participants With BRAF V600 Mutation-Positive Cancers | Clinical Trials | Clareo Health

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

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

NCT01524978•Hoffmann-La Roche

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

Age

16 - No limit years

Sex

ALL

Healthy Volunteers

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
+1 more criteria

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

Locations (34)

Arizona Oncology

Tucson, Arizona, United States

Rocky Mountain Cancer Centers, LLP

Aurora, Colorado, United States

Massachusetts General Hospital;Oncology

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Washington University

St Louis, Missouri, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Vanderbilt

Nashville, Tennessee, United States

University of Texas M.D. Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

April 12, 2012

Primary Completion Date

October 28, 2016

Completion Date

October 28, 2016

Last Updated

November 20, 2017

Enrollment

208

ACTUAL participants

Conditions

Multiple Myeloma, Neoplasms

Interventions

cetuximab

DRUG

vemurafenib

DRUG

vemurafenib

DRUG