A Phase 3, Double-Blind Extension Study Evaluating the Efficacy and Safety of Two Different Dose Levels of Single-Agent Idelalisib (GS-1101) as Therapy for Patients With Previously Treated Chronic Lymphocytic Leukemia
18 Years
N/A
Both
Chronic Lymphocytic Leukemia
Trial Information
A Phase 3, Double-Blind Extension Study Evaluating the Efficacy and Safety of Two Different Dose Levels of Single-Agent Idelalisib (GS-1101) as Therapy for Patients With Previously Treated Chronic Lymphocytic Leukemia
This study (GS-US-312-0117) is a multicenter, 2-arm, double-blind, parallel-group extension
study that is a companion study to Study GS-US-312-0116; in this study, compliant subjects
from GS-US-312-0116 who are tolerating primary study therapy but experience CLL progression
are eligible to receive active Idelalisib therapy.
Inclusion Criteria
Inclusion:
- Subjects in the primary Phase 3 study (Study GS-US-312-0116) who are compliant
- Tolerating primary study therapy
- Have definitive progression of CLL while receiving primary study drug therapy
(Idelalisib/placebo).
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Outcome Measure:
Overall Response Rate
Outcome Time Frame:
12 months
Safety Issue:
No
Principal Investigator
Thomas Jahn, MD
Investigator Role:
Study Director
Investigator Affiliation:
Gilead Sciences
Authority:
United States: Food and Drug Administration
Study ID:
GS-US-312-0117
NCT ID:
NCT01539291
Start Date:
March 2012
Completion Date:
March 2016
Related Keywords:
- Chronic Lymphocytic Leukemia
- CLL
- CAL-101
- CAL 101
- GS-1101
- GS 1101
- PI3K
- Leukemia
- GS-US-312-0116
- idelalisib
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
Name | Location |
|---|---|
| Memorial Sloan Kettering Cancer Center | New York, New York 10021 |
| Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
| Texas Oncology, P.A. | Dallas, Texas 75246 |
| Oncology and Hematology Associates of Southwest Virginia, Inc. | Roanoke, Virginia 24014 |
| Hackensack University Medical Center | Hackensack, New Jersey 07601 |
| Long Island Jewish Medical Center | New Hyde Park, New York 11040 |
| Rocky Mountain Cancer Center | Denver, Colorado 80218 |
| Cancer Centers of the Carolinas | Greenville, South Carolina 29605 |
| Florida Cancer Specialists | Fort Myers, Florida 33901 |
| Stanford Cancer Center | Stanford, California 94305-5824 |
| Seattle Cancer Care Alliance | Seattle, Washington 98109 |
| Northwestern University | Chicago, Illinois 60611 |
| Willamette Valley Cancer Center | Eugene, Oregon 97401-8122 |
| University of Florida | Gainesville, Florida 32610-0277 |
| Arizona Oncology Associates | Tucson, Arizona 85712-2254 |
| M.D. Anderson Cancer Center | Houston, Texas 77030 |
| Sarah Cannon Cancer Center | Nashville, Tennessee 37203 |
| UCLA | Los Angeles, California 90095 |
| Hematology Oncology Associates of Northern New Jersey | Morristown, New Jersey 07960 |
| Georgetown University Medical Center Lombardi Cancer Center | Washington, District of Columbia 20007 |
| Clearview Cancer Institute | Huntsville, Alabama 35805 |
| Cancer Care Network of South Texas | San Antonio, Texas 78229 |
| Ventura County Hematology Oncology Specialists | Oxnard, California 93030 |
| Yakima Valley Memorial Hospital/North Star Lodge | Yakima, Washington 98902 |
| Weill Cornell Medical College | New York, New York 10021 |
| Rocky Mountain Blood and Marrow Transplant Program | Denver, Colorado 80218 |
| Northwest Cancer Specialists, PC | Portland, Oregon 97225 |
| Collaborative Research Group | Boynton Beach, Florida 33435 |
| Virginia Cancer Specialists, PC | Fairfax, Virginia 22031 |
| University of California, San Diego - Moores Cancer Center | La Jolla, California 92093 |
