A Study of RO5212054 (PLX3603) in Participants With BRAF V600-Mutated Advanced Solid Tumors

An Open-Label, Multiple Ascending Dose (MAD) Study of the Selective BRAF Inhibitor RO5212054 (PLX3603) to Evaluate Safety, Tolerability and Pharmacokinetics in Patients With BRAF V600-Mutated Advanced Solid Tumours

This open-label, multi-center study will evaluate the safety, tolerability, and pharmacokinetics of RO5212054 [PLX3603] in participants with BRAF V600-mutated advanced solid tumors. Cohorts of participants will receive escalating oral doses of RO5212054. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

Inclusion Criteria:

• Advanced solid tumor
• Dose-escalation phase: Histologically confirmed, newly diagnosed or relapsed/ refractory unresectable American Joint Committee on Cancer (AJCC) Stage IIIC or IV disease
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Adequate liver, renal and bone marrow function

Exclusion Criteria:

• Participants for whom standard therapy exists and is considered appropriate by the investigator
• Prior treatment with an inhibitor of BRAF (sorafenib allowed)
• Active Central nervous system (CNS) lesions, or history of or known carcinomatous meningitis
• Treatment with any chemotherapy, radiotherapy, immunotherapy or investigational agent within 28 days prior to first dose of study drug
• Anticipated or ongoing anti-cancer therapies other than those administered in this study
• Serious cardiovascular illness within the 6 months prior to study drug administration