An open-label, multicenter study to assess the safety ofRO5185426 in patients with metastatic melanoma

Phase 1

• Conditions: Patients with histologically confirmed metastatic melanoma harboring the BRAF V600 mutation as determined by the cobas® 4800 BRAF V600 Mutation Test.; MedDRA version: 14.1Level: LLTClassification code 10027481Term: Metastatic melanomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-023526-21-BG
• Lead Sponsor: F. Hoffmann-La Roche Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02-24
• Last Update Posted: 24 October 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 3300

Inclusion Criteria

- Male or female 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 therapy for metastatic melanoma
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Adequate hematologic, renal and liver function.

Are the trial subjects under 18? yes
Number of subjects for this age range: 3
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2381
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 914

Exclusion Criteria

- Evidence of symptomatic CNS lesions
- 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
- Known hypersensitivity to RO5185426 or another BRAF inhibitor
- 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
- Evidence of symptomatic CNS lesions as determined by investigator, use of steroids or anti-seizure medications for treatment of brain metastases prior to the first administration of RO5185426

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified