A Phase 2, Open-Label Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacodynamics of GS-9973 in Combination With Idelalisib in Subjects With Relapsed or Refractory Hematologic Malignancies
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate
Objective response rate (ORR) as assessed by the Independent Review Committee (IRC), defined as the subjects' best overall response during GS-9973/idelalisib therapy and will include complete response (CR) or partial response (PR) (or very good partial response [VGPR] or minor response [MR] for subjects with LPL/WM)
up to 48 weeks
No
Michael Hawkins, M.D.
Study Director
Gilead Sciences
United States: Food and Drug Administration
GS-US-339-0103
NCT01796470
April 2013
April 2016
Name | Location |
---|---|
Cancer Center of Santa Barbara | Santa Barbara, California 93105 |
Charleston Hematology Oncology | Charleston, South Carolina 29403 |
Northwest Medical Specialties | Tacoma, Washington 98405 |
Medical and Surgical Specialists, LLC | Galesburg, Illinois 61401 |
Ventura County Hematology Oncology Specialists | Oxnard, California 93030 |
Collaborative Research Group LLC | Boynton Beach, Florida 33435 |