An Open-label, Multicenter Study to Assess the Safety of RO5185426 in Patients With Metastatic Melanoma
Inclusion Criteria:
- Adult patients, >/= 16 years of age
- Histologically confirmed metastatic melanoma (surgically incurable and unresectable
stage IIIC or stage IV; AJCC) with BRAF V600 mutation determined by Cobas 4800 BRAF
Mutation Test
- Patients may or may not have received prior systemic therapy for metastatic melanoma
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Adequate hematologic, renal and liver function
Exclusion Criteria:
- Evidence of symptomatic CNS lesions, use of steroids or anti-seizure medications for
treatment of brain metastases prior to the first administration of RO5185426
- Previous malignancy (other than melanoma) within the past 2 years, except for treated
and controlled basal or squamous cell carcinoma of the skin or carcinoma in-situ of
the cervix
- Concurrent administration of any anti-cancer therapies other than those administered
in the study
- Clinically significant cardiovascular disease or event within the 6 months prior to
first administration of study drug
- Refractory nausea or vomiting, external biliary shunt, or significant bowel resection
that would preclude adequate absorption