Overview

This trial is active, not recruiting.

Condition malignant melanoma
Treatment ro5185426
Phase phase 3
Target BRAF
Sponsor Hoffmann-La Roche
Start date March 2011
End date December 2015
Trial size 3286 participants
Trial identifier NCT01307397, MO25515

Summary

This open-label, multicenter study will evaluate the safety and efficacy of RO5185426 in patients with BRAF V600 mutation-positive, surgically incurable and unresectable stage IIIC or IV metastatic melanoma. Eligible patients will receive RO5185426 (960 mg twice daily orally) until disease progression or unacceptable toxicity occurs, with a safety follow-up of 24 months after discontinuation of the study drug.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
ro5185426
960 mg twice daily orally

Primary Outcomes

Measure
Safety: Incidence of adverse events
time frame: approximately 4 years

Secondary Outcomes

Measure
Overall Response Rate, tumor assessments according to RECIST criteria
time frame: 22 months

Eligibility Criteria

Male or female participants at least 16 years old.

Inclusion Criteria: - Adult patients, >/= 16 years of age - Histologically confirmed metastatic melanoma (surgically incurable and unresectable stage IIIC or stage IV; AJCC) with BRAF V600 mutation determined by Cobas 4800 BRAF Mutation Test - Patients may or may not have received prior systemic therapy for metastatic melanoma - Eastern Cooperative Oncology Group (ECOG) performance status 0-2 - Adequate hematologic, renal and liver function Exclusion Criteria: - Evidence of symptomatic CNS lesions, use of steroids or anti-seizure medications for treatment of brain metastases prior to the first administration of RO5185426 - Previous malignancy (other than melanoma) within the past 2 years, except for treated and controlled basal or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix - Concurrent administration of any anti-cancer therapies other than those administered in the study - Clinically significant cardiovascular disease or event within the 6 months prior to first administration of study drug - Refractory nausea or vomiting, external biliary shunt, or significant bowel resection that would preclude adequate absorption

Additional Information

Official title An Open-label, Multicenter Study to Assess the Safety of RO5185426 in Patients With Metastatic Melanoma
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.