An Open-Label Study of Zelboraf (Vemurafenib) in Patients With Braf V600 Mutation Positive Metastatic Melanoma

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.

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.

Inclusion Criteria:

• Adults patients >= 18 years of age
• Patients with histologically confirmed metastatic melanoma (surgically incurable and unresectable stage IIIC or stage IV; AJCC) with documented BRAF V600 mutation determined by the cobas® BRAF V600 Mutation Test prior to administration of vemurafenib. Unresectable stage IIIC disease must have confirmation from a surgical oncologist
• Patients with either measurable or non-measurable disease (RECIST Version 1.1)
• Patients may or may not have received prior systemic therapy for metastatic melanoma
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
• Patients must have recovered from all side effects of their most recent systemic or local treatment for metastatic melanoma
• Adequate hematological, renal, and liver function
• Negative serum pregnancy test at screening
• Fertile men and women must use an effective form of contraception during the study and for at least 6 months after completion of the study

Exclusion Criteria:

• Evidence of symptomatic CNS lesions as determined by the investigator, use of steroid or anti-seizure medication for treatment of brain metastases prior to the first administration of vemurafenib
• Patients with previous malignancies (other than melanoma) within the past 2 years except patients with treated and controlled basal or squamous cell carcinoma (SCC) of the skin or carcinoma in-situ of the cervix.
• Concurrent administration of any anti-cancer therapies (e.g. chemotherapy, other targeted therapy, experimental drug, etc.) other than those administered in this study
• Known hypersensitivity to vemurafenib or another BRAF inhibitor
• Pregnant or lactating women
• Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption.
• Any of the following within the 6 months prior to the first vemurafenib administration: myocardial infarction, severe/unstable angina, symptomatic congestive heart failure, cerebrovascular accident or transient ischaemic attack, pulmonary embolism, hypertension not adequately controlled by current medications.