A Study of RO5185426 in Patients With Metastatic Melanoma

Inclusion Criteria:

• Histologically confirmed metastatic melanoma with documented BRAF V600E mutation, determined by the cobas BRAF V600 mutation test
• Patients with clinical evidence of disease progression during or after at least one prior systemic therapy for metastatic melanoma
• Patients with either measurable or non-measurable disease
• Adequate recovery from most recent systemic or local treatment for metastatic melanoma
• Adequate organ funcion
• For women of childbearing potential, agreement to the use of two acceptable methods of contraception, including one barrier method, during the study and for 6 months after discontinuation of RO5185426
• For men with female partners of childbearing potential, agreement to use a latex condom, and to advise their female partner to use an additional method of contraception during the study and for 6 months after discontinuation of RO5185426
• Negative serum or urine pregnancy test within 7 days of commencement of treatment in premenopausal women. Women who are either surgically sterile or have been post-menopausal for at least 1 year are eligible to participate in this study
• Agreement not to donate blood or blood products during the study and for at least 6 months after disconinuation of RO5185426; for male patients, agreement not to donate sperm during the study and for at least 6 months after discontinuation of RO5185426

Exclusion Criteria:

• Evidence of symptomatic CNS lesions as determined by investigator
• Patients with a previous malignancy within the past 2 years are excluded except for patients with basal or squamous cell carcinoma (SCC) of the skin or carcinoma in-situ of the cervix. Isolated elevation in PSA in absence of radiographic evidence of metastatic prostate cancer is allowed
• Pregnant or breast-feeding
• Concurrent anti-tumor therapy
• Any of the following within 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, hypertension not adequately controlled by current medications
• Uncontrolled medical illness