A Study of Vemurafenib in Metastatic Melanoma Patients With Brain Metastases



Status:Completed
Conditions:Skin Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:July 2011
End Date:July 2015

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An Open-label, Single-arm, Phase II, Multicenter Study, to Evaluate the Efficacy of Vemurafenib in Metastatic Melanoma Patients With Brain Metastases

This open-label, single-arm, multicenter study will evaluate the efficacy and safety in
patients with metastatic melanoma who developed brain metastases. Patients may or may not
have received prior treatment for metastatic melanoma with brain metastases (except
treatment with BRAF or MEK inhibitors). Patients will receive oral doses of 960 mg
vemurafenib twice daily until disease progression, unacceptable toxicity or consent
withdrawal.


Inclusion Criteria:

- Adult patients, >/= 18 years of age

- Metastatic melanoma (Stage IV, American Joint Committee on Cancer) with BRAF V600
mutation (cobas 4800 BRAF V600 Mutation Test)

- Measurable brain metastases, treated or untreated

- Patients may or may not have received prior systemic therapy for metastatic melanoma
and either a) have received no prior treatment for brain metastases or b) have
received prior treatment for brain metastases and have progressed

- Patients may or may not have symptoms related to their brain metastases

- Eastern Cooperative Oncology Group (ECOG) performance status 0-1

- Patients must have recovered from all side effects of their most recent systemic or
local treatment for metastatic melanoma

Exclusion Criteria:

- Increasing corticosteroid dose during the 7 days prior to first dose of study drug

- Leptomeningeal involvement

- Previous malignancy requiring active treatment within the past 2 years, except for
treated and controlled basal or squamous cell carcinoma of the skin, or carcinoma
in-situ of the cervix

- Concurrent administration of any anticancer therapies other than those administered
in the study

- Treatment with any cytotoxic, investigational drug or targeted therapy 4 weeks prior
to first dose of study drug. Radiation therapy 2 weeks prior to first dose of study
drug

- Prior treatment with BRAF or MEK inhibitors

- Clinically significant cardiovascular disease or event within the 6 months prior to
first dose of study drug
We found this trial at
12
sites
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Aurora, CO
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Boston, MA
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Charlotte, North Carolina 28207
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Charlotte, NC
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Dallas, TX
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Detroit, MI
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Las Vegas, NV
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Los Angeles, CA
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from
Rochester, MN
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from
Saint Louis, MO
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Seattle, WA
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Tampa, FL
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Wentworthville, New South Wales 2145
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from
Wentworthville,
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