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

• Status: Completed
• Trial end date: 2017-05-02
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche

Criteria

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