A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-6624 Combined With FOLFIRI as Second Line Treatment for Metastatic KRAS Mutant Colorectal Adenocarcinoma That Has Progressed Following a First Line Oxaliplatin- and Fluoropyrimidine-Containing Regimen.
This randomized Phase 2 study compares the additive efficacy of GS-6624 versus placebo in
combination with FOLFIRI in subjects with metastatic KRAS or BRAF mutant colorectal cancer.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Progression Free Survival
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.
Yes
Mike Hawkins, M.D.
Study Director
Gilead Sciences
United States: Food and Drug Administration
GS-US-295-0203
NCT01479465
November 2011
June 2014
Name | Location |
---|---|
Stanford University Medical Center | Stanford, California 94305-5408 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Joe Arrington Cancer Research and Treatment Center | Lubbock, Texas 79410-1894 |
Virginia Piper Cancer Institute | Minneapolis, Minnesota 55407 |
Florida Hospital Cancer Institute | Orlando, Florida 32804 |
Comprehensive Cancer Centers of Nevada | Las Vegas, Nevada 89109 |
University of Texas Southwestern Medical Center at Dallas | Dallas, Texas 75235-8897 |
Wilshire Oncology Medical Group, Inc. | Rancho Cucamonga, California 91730 |
Florida Cancer Specialists | Fort Myers, Florida 33901 |
Center for Biomedical Research | Knoxville, Tennessee 37909 |
Comprehensive Blood and Cancer Center | Bakersfield, California 93309 |
Seattle Cancer Care Alliance | Seattle, Washington 98109 |
Pacific Shores Medical Group | Long Beach, California 90813 |
Cancer Care Associates Medical Group | Torrance, California 90505 |
South Carolina Oncology Associates | Columbia, South Carolina 29201 |
Georgetown University | Washington, District of Columbia 20007-2197 |
Northwestern University | Chicago, Illinois 60611 |
The University of Chicago Medical Center | Chicago, Illinois 60637-1470 |
Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
Louisiana State University Health Sciences Center | Shreveport, Louisiana 71130 |
Oncology Hematology Care, Inc. | Cincinnati, Ohio 45219 |
Virginia Cancer Institute | Richmond, Virginia 23230 |
Tufts Medical Center | Boston, Massachusetts 02111 |
The Center for Cancer and Blood Disorders | Fort Worth, Texas 76104 |
Utah Cancer Specialists | Salt Lake City, Utah 84106 |
Compassionate Cancer Care medical Group, Inc. | Fountain Valley, California 92708 |
Sharp Health Care | San Diego, California 92123 |
University of Wisconsin | Madison,, Wisconsin 53792-5666 |
Desert Hematology Oncology Medical Group, Inc. | Rancho Mirage, California 92270 |
Birmingham Hematology and Oncology Associates, LLC | Birmingham, Alabama 35235 |
Southeast Nebraska Cancer Center | Lincoln, Nebraska 68510 |
Tennessee Oncology, PLLC | Clarksville, Tennessee 37043 |
Peachtree Hematology Oncology Consultants, PC | Atlanta, Georgia 30309 |
Central Hematology Oncology Medical Group, Inc. | Alhambra, California 91801 |
Providence Medical Group | Terre Haute, Indiana 47802 |
South Texas Oncology and Hematology, PA | San Antonio, Texas 78229 |
Beth Israel Comprehensive Cancer Center | New York, New York |
Pacific Cancer Medical Center, Inc. | Anaheim, California 92801 |
Indiana University Simon Cancer Center | Indianapolis, Indiana 46202 |
Signal Point Clinical Research Center, LLC | Middletown, Ohio 45042 |
Charleston Hematology Oncology Associates | Charleston, South Carolina 29403 |
University of California San Diego Medical Center | San Diego, California 92103-8409 |
Arizona Center for Cancer Care | Glendale, Arizona 85306 |
Owsley Brown Frazier Cancer Center | Louisville, Kentucky 40245 |
Kaiser Permanente Northwest Region Oncology Hematology | Portland, Oregon 97227 |
Hematology Oncology Associates | Oakland, California 94609 |
White Memorial Medical Center | Los Angeles, California 90033 |
Hematology and Oncology Associates at BridgePoint | Tupelo, Mississippi 38801 |
Emerywood Hematology and Oncology | High Point, North Carolina 27262 |
Pinnacle Health | Harrisburg, Pennsylvania 17110 |
UCLA Community Oncology Practice | Los Angeles, California |
Saint Mary's Regional Cancer Center | Grand Junction, Colorado |
Anne Arundel Medical Center, Annapolis Oncology Center | Annapolis, Maryland |
Saint Joseph Oncology, Inc. | Saint Joseph, Missouri |
Center for Cancer and Blood Disorders, PC | Fort Worth, Texas |
Saint Jude Heritage Healthcare | Fullerton, California |
Central Coast Medical Oncology Corp | Santa Maria, California |
Suburban Hematology Oncology Associates, PC | Lawrenceville, Georgia |
Research Foundation of State University of New York | Syracuse, New York |
The Stamford Hospital | Stamford, Connecticut 06902 |
San Jose Medical Group | San Jose, California 95116 |
PinnacleHealth | Harrisburg, Pennsylvania 17109 |
San Antonio Military Medical Center | Fort Sam Houston, Texas 78234 |
Providence Saint Joseph Medical Center-Disney Family Cancer Center | Burbank, California |
TORI Network (Translational Oncology Research Intl) | Los Angeles, California |
Comprehensive Hematology Oncology Centers, Inc. | Los Angeles, California |
North County Oncology Medical Clinical Inc. | Oceanside, California |
Hematology Oncology Medical Group of Orange County | Orange, California |
Yale University Smilow Cancer Hospital | New Haven, Connecticut 06520 |
New York University Clincial Cancer Center | New York, New York 10016 |
University of Pittsburgh Medical Center, Cancer Centers | Pittsburgh, Pennsylvania |