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Brief Title: An Open-Label Study of Zelboraf (Vemurafenib) in Patients With Braf V600 Mutation Positive Metastatic Melanoma
Official Title: An Open-Label, Single-Arm, Multicenter Study To Assess The Safety Of Vemurafenib In Patients With Braf V600 Mutation Positive Metastatic Melanoma In South Africa.
Study ID: NCT01898585
Brief Summary: 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
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
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR