A SINGLE ARM, OPEN LABEL, EXPANDED ACCESS STUDY OF RG7204 IN PREVIOUSLY TREATED 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