EUCTR2010-023526-21-BG
Active, not recruiting
Phase 1
An open-label, multicenter study to assess the safety ofRO5185426 in patients with metastatic melanoma
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- F. Hoffmann-La Roche Ltd.
- Enrollment
- 3300
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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