A Study of RO5185426 in Previously Treated Melanoma Patients With Brain Metastases

• Status: Completed
• Trial end date: 2012-03-14
• Target enrollment: 0
• Participant gender: All

Summary

This open-label study will assess the safety and efficacy of RO5185426 in previously treated metastatic melanoma patients with brain metastases. Patients will receive RO5185426 at a dose of 960 mg twice daily orally until disease progression or unacceptable toxicity occurs.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche

Criteria

Inclusion Criteria:

• Adult patients, >/= 18 years of age

• Metastatic melanoma (Stage IV, American Joint Committee on Cancer) with BRAF mutation (cobas 4800 BRAF V600 Mutation Test)

• Brain metastases for which surgical resection is not a treatment option

• Patients must have failed at least one previous treatment for brain metastases

• Requiring corticosteroids for symptom control

• Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Exclusion Criteria:

• Increasing corticosteroid dose during the 7 days prior to study entry

• Previous malignancy within the past 2 years, except for basal or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix

• Concurrent administration of any anticancer therapies other than those administered in the study

• Clinically significant cardiovascular disease or event within the 6 months prior to first dose of study drug