A Study of Vemurafenib in Participants With BRAF V600 Mutation-Positive Cancers
NCT ID: NCT01524978
Last Updated: 2017-11-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
208 participants
INTERVENTIONAL
2012-04-12
2016-10-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - vemurafenib
Participants with NSCLC will be treated with vemurafenib monotherapy.
vemurafenib
960 mg vemurafenib orally twice a day until disease progression, unacceptable toxicity, or withdrawal of consent.
Cohort 2: Ovarian Cancer - vemurafenib
Participants with ovarian cancer will be treated with vemurafenib monotherapy.
vemurafenib
960 mg vemurafenib orally twice a day until disease progression, unacceptable toxicity, or withdrawal of consent.
Cohort 3a: Colorectal Cancer - vemurafenib
Participants with colorectal cancer will be treated with vemurafenib monotherapy.
vemurafenib
960 mg vemurafenib orally twice a day until disease progression, unacceptable toxicity, or withdrawal of consent.
Cohort 3b: Colorectal Cancer - vemurafenib + cetuximab
Participants with colorectal cancer will be treated with vemurafenib and cetuximab combination therapy.
cetuximab
Escalating doses administered on Day 1 and then once weekly by intravenous infusion.
vemurafenib
Escalating doses given orally twice a day starting on Day 2
Cohort 4: Cholangiocarcinoma - vemurafenib
Participants with cholangiocarcinoma will be treated with vemurafenib monotherapy.
vemurafenib
960 mg vemurafenib orally twice a day until disease progression, unacceptable toxicity, or withdrawal of consent.
Cohort 6: Multiple Myeloma - vemurafenib
Participants with multiple myeloma will be treated with vemurafenib monotherapy.
vemurafenib
960 mg vemurafenib orally twice a day until disease progression, unacceptable toxicity, or withdrawal of consent.
Cohort 7: Other Solid Tumors - vemurafenib
Participants with Erdheim-Chester disease (ECD), Langerhans cell histiocytosis (LCH), anaplastic thyroid cancer, advanced stage astrocytoma, early stage astrocytoma and other BRAF V600-positive tumors will be treated with vemurafenib monotherapy. Subcohorts will be analyzed separately if 7 or more participants are enrolled for each indication.
vemurafenib
960 mg vemurafenib orally twice a day until disease progression, unacceptable toxicity, or withdrawal of consent.
Interventions
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cetuximab
Escalating doses administered on Day 1 and then once weekly by intravenous infusion.
vemurafenib
Escalating doses given orally twice a day starting on Day 2
vemurafenib
960 mg vemurafenib orally twice a day until disease progression, unacceptable toxicity, or withdrawal of consent.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
16 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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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
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Barcelona, , Spain
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
Madrid, , Spain
Fundacion Jimenez Diaz; Servicio de Oncologia
Madrid, , Spain
Centro Integral Oncologico Clara Campal (CIOCC); Dirección Médica
Madrid, , Spain
Hospital Clinico Universitario de Salamanca; Servicio de Oncologia
Salamanca, , Spain
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
Valencia, , Spain
Aberdeen Royal Infirmary
Aberdeen, , United Kingdom
The Royal Marsden Hospital; Dept of Medicine
London, , United Kingdom
The Royal Marsden Hospital
Sutton, , United Kingdom
Countries
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References
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Subbiah V, Burris HA 3rd, Kurzrock R. Revolutionizing cancer drug development: Harnessing the potential of basket trials. Cancer. 2024 Jan;130(2):186-200. doi: 10.1002/cncr.35085. Epub 2023 Nov 7.
Kaley T, Touat M, Subbiah V, Hollebecque A, Rodon J, Lockhart AC, Keedy V, Bielle F, Hofheinz RD, Joly F, Blay JY, Chau I, Puzanov I, Raje NS, Wolf J, DeAngelis LM, Makrutzki M, Riehl T, Pitcher B, Baselga J, Hyman DM. BRAF Inhibition in BRAFV600-Mutant Gliomas: Results From the VE-BASKET Study. J Clin Oncol. 2018 Dec 10;36(35):3477-3484. doi: 10.1200/JCO.2018.78.9990. Epub 2018 Oct 23.
Hyman DM, Puzanov I, Subbiah V, Faris JE, Chau I, Blay JY, Wolf J, Raje NS, Diamond EL, Hollebecque A, Gervais R, Elez-Fernandez ME, Italiano A, Hofheinz RD, Hidalgo M, Chan E, Schuler M, Lasserre SF, Makrutzki M, Sirzen F, Veronese ML, Tabernero J, Baselga J. Vemurafenib in Multiple Nonmelanoma Cancers with BRAF V600 Mutations. N Engl J Med. 2015 Aug 20;373(8):726-36. doi: 10.1056/NEJMoa1502309.
Other Identifiers
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2011-004426-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MO28072
Identifier Type: -
Identifier Source: org_study_id