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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.


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer

Thank you

Trial Information

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.


Inclusion Criteria:



- Metastatic Colorectal Carcinoma with KRAS mutation.

- Received first line therapy and discontinued part or all of first line therapy.

- Estimated life expectancy > 3 months.

- Stage IV disease.

- ECOG 0-2.

- Adequate hepatic and hematologic function

- No major operations within 4 weeks prior to treatment start.

Exclusion Criteria:

- More than 1 prior chemotherapy regimen for stage 4 colorectal cancer.

- Experimental medical treatment within 30 days prior to study entry.

- Known or suspected cerebral metastases.

- History or presence of any form of cancer, other that colorectal cancer, within the 3
years prior to enrollment.

- Known dihydropyrimidine dehydrogenase-deficiency (special screening not required).

- Subjects with angina pectoris, poorly controlled ventricular arrhythmias (does not
include asymptomatic, occasional premature ventricular contractions), history of
clinically significant coronary heart disease or cardiomyopathy, or ECG abnormalities
consistent with ischemia.

- Uncontrolled hypertension (seated systolic blood pressure > 180 mmHg or diastolic
blood pressure > 110 mmHg) at Screening.

- Clinically active liver disease, including active hepatitis (any etiology) or
cirrhosis.

- Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy,
retinoid therapy, hormonal therapy) within 21 days prior to randomization

- Prior irinotecan therapy for metastatic disease is not permitted.

- Systemic fungal, bacterial, viral, or other infection.

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:

Progression Free Survival

Outcome Time Frame:

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.

Safety Issue:

Yes

Principal Investigator

Mike Hawkins, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Gilead Sciences

Authority:

United States: Food and Drug Administration

Study ID:

GS-US-295-0203

NCT ID:

NCT01479465

Start Date:

November 2011

Completion Date:

June 2014

Related Keywords:

  • Colorectal Cancer
  • GSI
  • Gilead
  • Gilead Sciences
  • GS-6624
  • Colorectal Cancer
  • KRAS
  • Oncology
  • monoclonal antibody
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Colorectal Neoplasms

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