A Study of Vemurafenib in Participants With BRAF V600 Mutation-Positive Cancers
Status: | Completed |
---|---|
Conditions: | Hematology |
Therapuetic Areas: | Hematology |
Healthy: | No |
Age Range: | 16 - Any |
Updated: | 11/22/2017 |
Start Date: | April 12, 2012 |
End Date: | October 28, 2016 |
An Open-label, Phase II Study of Vemurafenib in Patients With BRAF V600 Mutation-positive Cancers
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.
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.
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
- 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
- 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
We found this trial at
12
sites
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Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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