Status:
COMPLETED
A Study of Vemurafenib in Previously Treated Patients With Metastatic Melanoma
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Malignant Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This open-label single arm study will assess the efficacy, safety and tolerability of Vemurafenib in previously treated patients with metastatic melanoma. Patients will receive oral Vemurafenib \[RG72...
Eligibility Criteria
Inclusion
- adult patients \>/=18 years of age
- histologically confirmed metastatic melanoma (Stage IV, AJCC)
- patients must have completed and failed at least one prior standard of care regimen (e.g. DTIC, temozolomide, etc.)
- BRAF V600E positive mutation (by Roche CoDx BRAF mutation assay)
- measurable disease by RECIST criteria
- negative pregnancy test and, for fertile men and women, effective contraception during treatment and for 6 months after completion
Exclusion
- active CNS metastases on CT/MRI within 28 days prior to enrollment
- history of or known carcinomatous meningitis
- previous treatment with BRAF (sorafenib allowed) or MEK inhibitor
- cardiac dysrhythmias \>2 NCI CTCAE or treatment with drugs with dysrhythmic potential
- uncontrolled hypertension(\>150/100mmHg) despite optimal medical therapy
- infectious disease including HIV, HBV and HCV
Key Trial Info
Start Date :
September 30 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 3 2014
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT00949702
Start Date
September 30 2009
End Date
June 3 2014
Last Update
July 25 2017
Active Locations (15)
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1
UCLA - School of Medicine; Division of Hematology/Oncology
Los Angeles, California, United States, 90095-6984
2
University of Colorado
Denver, Colorado, United States, 80262
3
Moffitt Cancer Center
Tampa, Florida, United States, 33612
4
Massachusetts General Hospital;Hematology/ Oncology
Boston, Massachusetts, United States, 02114