A Phase IB, Open-Label, Dose-Escalation Study Evaluating the Safety, Tolerability and Pharmacokinetics of Vemurafenib in Combination With GDC-0973 When Administered in BRAFV600E Mutation-Positive Patients Previously Treated (But Without Prior Exposure to BRAF or MEK Inhibitor Therapy) or Previously Untreated for Locally- Advanced/Unresectable or Metastatic Melanoma or Those Who Have Progressed After Treatment With Vemurafenib
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Dose-limiting toxicity of vemurafenib in combination with GDC-0973
Cycle 1: Day 28
Yes
Clinical Trials
Study Director
Hoffmann-La Roche
United States: Food and Drug Administration
NO25395
NCT01271803
February 2011
October 2014
Name | Location |
---|---|
Hinsdale, Illinois 60521 | |
Fountain Valley, California 92708 | |
Albany, New York 12208 | |
Nashville, Tennessee 37203-1632 | |
Flint, Michigan 48532 | |
Denver, Colorado | |
Indianapolis, Indiana |