Vemurafenib + Fotemustine to Treat Advanced Melanoma Patients With V600BRAF Mutation Recurred While on Vemurafenib

Exclusion Criteria

• •Female subjects who are pregnant or nursing
• •Female subjects of childbearing potential or males not using or not willing to use two forms of effective contraception
• •Any of the following within the 6 months prior to randomization: myocardial infarction, severe/unstable angina, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, hypertension not adequately controlled by current medications
• •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
• •History of congenital long QT syndrome, history or presence of clinically significant ventricular or atrial dysrhythmias ≥ Grade 2 (NCI Common Toxicity Criteria for Adverse Effects (CTCAE) Version 4.0
• •Corrected QT (QTc) interval ≥ 500 msec at baseline
• •Uncontrolled medical illness (such as infection requiring treatment with intravenous (IV) antibiotics)
• •Has had surgery within 2 weeks (1 week for minor surgery, eg, procedures requiring only local anesthetics) prior to the first dose of study medication