An Open-label, Single-arm, Phase II, Multicenter Study, to Evaluate the Efficacy of Vemurafenib in Metastatic Melanoma Patients With Brain Metastases
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Best Overall Response Rate (BORR) in previously untreated brain metastases (assessed by Independent Review Committee using Response Evaluation Criteria in Solid Tumors (RECIST))
Until disease progression, unacceptable toxicity or consent withdrawal (approximately 2 years)
No
Clinical Trials
Study Director
Hoffmann-La Roche
United States: Food and Drug Administration
MO25743
NCT01378975
July 2011
December 2013
Name | Location |
---|---|
Alexandria, Minnesota 56308 | |
Fountain Valley, California 92708 | |
Miami, Florida 33176 | |
Columbia, Missouri 65203 | |
Austin, Texas 78705 | |
Seattle, Washington 98195 | |
Flint, Michigan 48532 | |
Denver, Colorado | |
Boston, Massachusetts | |
Charlotte, North Carolina | |
Las Vegas, Nevada 89109 |