Status:
COMPLETED
A Study of RO5185426 in Previously Treated Melanoma Patients With Brain Metastases
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Malignant Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 twi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 22 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 14 2012
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01253564
Start Date
November 22 2010
End Date
March 14 2012
Last Update
July 31 2017
Active Locations (2)
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1
CHUV; Departement d'Oncologie
Lausanne, Switzerland, 1011
2
Universitätsspital Zürich; Dermatologische Klinik
Zurich, Switzerland, 8091