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

Roche

Status and phase: Completed; Phase 2

Conditions: Malignant Melanoma

Treatments: Drug: RO5185426

Study type: Interventional

Funder types: Industry

Identifiers

NCT01253564

MO25653

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Single Arm

Experimental group

Treatment:

Drug: RO5185426