A Study of Vemurafenib in Participants With BRAF V600 Mutation-Positive Cancers
Completed · Phase 2
Conditions studied: Multiple Myeloma, Neoplasms
In brief
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.
Key facts
- Study ID
- NCT01524978
- Run by
- Hoffmann-La Roche
- People needed
- 208
- Starts
- 2012-04-12
- Expected to finish
- 2016-10-28
- Last updated by the study team
- 2017-11-20
Who can join
Age: 16 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- 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
- Yakima Valley Memorial Hospital/North Star Lodge — Yakima, Washington, United States
- Tianjin Cancer Hospital — Tianjin, China
- Institut Bergonie; Oncologie — Bordeaux, France
- Centre Francois Baclesse; Oncologie — Caen, France
- Centre Georges François Leclerc — Dijon, France
- Centre Leon Berard; Departement Oncologie Medicale — Lyon, France
- Institut Paoli-Calmettes; Oncologie Medicale 1 — Marseille, France
- Centre Rene Gauducheau — Saint-Herblain, France
- Institut Claudius Regaud; Departement Oncologie Medicale — Toulouse, France
- Institut Gustave Roussy; Sitep — Villejuif, France
- Klinik der Uni zu Koeln; Klinik I für Innere Medizin; Onkologie — Cologne, Germany
- Universitätsklinikum Essen; Innere Klinik und Poliklinik für Tumorforschung — Essen, Germany
- Universitätsklinikum Mannheim, Tagestherapiezentrum, Interdisziplinäres Tumorzentrum — Mannheim, Germany
- Hospital Univ. Central de Asturias; Servicio de Oncologia — Oviedo, Principality of Asturias, Spain
- Hospital del Mar; Servicio de Oncologia — Barcelona, Spain
Full record on ClinicalTrials.gov
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