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: 19.1Level: LLTClassification code 10027481Term: Metastatic melanomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02-04
• Last Update Posted: 13 March 2017

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