This open-label, single-arm, multicenter study will assess the safety and efficacy of Zelboraf (vemurafenib) in patients with Braf V600 mutation positive metastatic melanoma. Patients will receive Zelboraf 960 mg twice a day until progressive disease, unacceptable toxicity, consent withdrawal, death, reasons deemed by the treating physician or study termination.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Vemurafenib 960 mg twice a day until progressive disease, unacceptable toxicity, consent withdrawal, death, reasons deemed by the treating physician or study termination.
National Hospital; Oncotherapy Dept
Bloemfontein, South Africa
Groote Schuur Hospital ( Uni of Capetown ); Oncology Dept
Cape Town, South Africa
Cape Town Oncology Trials
Cape Town, South Africa
Cancercare
Cape Town, South Africa
Safety: Incidence of adverse events
Time frame: 12 months
Overall response rate according to Response evaluation criteria in solid tumors (RECIST v1.1)
Time frame: 12 months
Progression free survival
Time frame: 12 months
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Cancercare
George, South Africa
Mary Potter Oncology Centre
Groenkloof, South Africa
Medical Oncology Centre of Rosebank; Oncology
Johannesburg, South Africa
University of Pretoria; Department of Medical Oncology
Pretoria, South Africa
Sandton Oncology Medical Group
Sandton, South Africa