Melanoma Clinical Trial
A Study of Vemurafenib in Metastatic Melanoma Participants With Brain Metastases
Summary
This open-label, single-arm, multicenter study will evaluate the efficacy and safety in participants with metastatic melanoma who developed brain metastases. Participants may or may not have received prior systemic treatment for metastatic melanoma [except treatment with v-raf murine sarcoma viral oncogene homolog B (BRAF) or mitogen-activated protein kinase (MEK) inhibitors]. Participants will receive oral doses of 960 mg vemurafenib twice daily until disease progression, unacceptable toxicity or consent withdrawal.
Eligibility Criteria
Inclusion Criteria:
Adult participants, >/= 18 years of age
Histologically confirmed metastatic melanoma (Stage IV, American Joint Committee on Cancer) with BRAF V600 mutation (cobas 4800 BRAF V600 Mutation Test)
Measurable brain metastases, defined as lesions that were accurately measured in at least one dimension (longest diameter to be recorded) as ≥0.5 cm in the brain MRI with contrast, treated or untreated
Participants 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
Participants may or may not have symptoms related to their brain metastases
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Participants 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 in participants with no prior treatment for brain metastases
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 ≤1 week prior to first administration of vemurafenib; and stereotactic radiotherapy ≤1 day prior to prior to first administration of vemurafenib
Prior treatment with BRAF or MEK inhibitors
Clinically significant cardiovascular disease or event within the 6 months prior to first dose of study drug
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There are 33 Locations for this study
Los Angeles California, 90025, United States
Aurora Colorado, 80045, United States
Tampa Florida, 33612, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02215, United States
Detroit Michigan, 48201, United States
Rochester Minnesota, 55905, United States
Saint Louis Missouri, 63110, United States
Charlotte North Carolina, 28204, United States
Dallas Texas, 75246, United States
Seattle Washington, 98195, United States
Wentworthville New South Wales, 2145, Australia
Melbourne Victoria, 3002, Australia
Toronto Ontario, M4N 3, Canada
Bordeaux , 33075, France
Nice , 06202, France
Paris , 75006, France
Paris , 75475, France
Essen , 45122, Germany
Frankfurt , 60596, Germany
Kiel , 24105, Germany
Mannheim , 68167, Germany
Münster , 48157, Germany
Tübingen , 72076, Germany
Tel-Hashomer , 52621, Israel
Milano Lombardia, 20133, Italy
Siena Toscana, 53100, Italy
Amsterdam , 1066 , Netherlands
Groningen , 9713 , Netherlands
Pamplona Navarra, 31008, Spain
Barcelona , 08036, Spain
Madrid , 28046, Spain
Northwood , HA6 2, United Kingdom
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