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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 CenterStanford, California  94305-5408
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Joe Arrington Cancer Research and Treatment CenterLubbock, Texas  79410-1894
Virginia Piper Cancer InstituteMinneapolis, Minnesota  55407
Florida Hospital Cancer InstituteOrlando, Florida  32804
Comprehensive Cancer Centers of NevadaLas Vegas, Nevada  89109
University of Texas Southwestern Medical Center at DallasDallas, Texas  75235-8897
Wilshire Oncology Medical Group, Inc.Rancho Cucamonga, California  91730
Florida Cancer SpecialistsFort Myers, Florida  33901
Center for Biomedical ResearchKnoxville, Tennessee  37909
Comprehensive Blood and Cancer CenterBakersfield, California  93309
Seattle Cancer Care AllianceSeattle, Washington  98109
Pacific Shores Medical GroupLong Beach, California  90813
Cancer Care Associates Medical GroupTorrance, California  90505
South Carolina Oncology AssociatesColumbia, South Carolina  29201
Georgetown UniversityWashington, District of Columbia  20007-2197
Northwestern UniversityChicago, Illinois  60611
The University of Chicago Medical CenterChicago, Illinois  60637-1470
Dana Farber Cancer InstituteBoston, Massachusetts  02115
Louisiana State University Health Sciences CenterShreveport, Louisiana  71130
Oncology Hematology Care, Inc.Cincinnati, Ohio  45219
Virginia Cancer InstituteRichmond, Virginia  23230
Tufts Medical CenterBoston, Massachusetts  02111
The Center for Cancer and Blood DisordersFort Worth, Texas  76104
Utah Cancer SpecialistsSalt Lake City, Utah  84106
Compassionate Cancer Care medical Group, Inc.Fountain Valley, California  92708
Sharp Health CareSan Diego, California  92123
University of WisconsinMadison,, Wisconsin  53792-5666
Desert Hematology Oncology Medical Group, Inc.Rancho Mirage, California  92270
Birmingham Hematology and Oncology Associates, LLCBirmingham, Alabama  35235
Southeast Nebraska Cancer CenterLincoln, Nebraska  68510
Tennessee Oncology, PLLCClarksville, Tennessee  37043
Peachtree Hematology Oncology Consultants, PCAtlanta, Georgia  30309
Central Hematology Oncology Medical Group, Inc.Alhambra, California  91801
Providence Medical GroupTerre Haute, Indiana  47802
South Texas Oncology and Hematology, PASan Antonio, Texas  78229
Beth Israel Comprehensive Cancer CenterNew York, New York  
Pacific Cancer Medical Center, Inc.Anaheim, California  92801
Indiana University Simon Cancer CenterIndianapolis, Indiana  46202
Signal Point Clinical Research Center, LLCMiddletown, Ohio  45042
Charleston Hematology Oncology AssociatesCharleston, South Carolina  29403
University of California San Diego Medical CenterSan Diego, California  92103-8409
Arizona Center for Cancer CareGlendale, Arizona  85306
Owsley Brown Frazier Cancer CenterLouisville, Kentucky  40245
Kaiser Permanente Northwest Region Oncology HematologyPortland, Oregon  97227
Hematology Oncology AssociatesOakland, California  94609
White Memorial Medical CenterLos Angeles, California  90033
Hematology and Oncology Associates at BridgePointTupelo, Mississippi  38801
Emerywood Hematology and OncologyHigh Point, North Carolina  27262
Pinnacle HealthHarrisburg, Pennsylvania  17110
UCLA Community Oncology PracticeLos Angeles, California  
Saint Mary's Regional Cancer CenterGrand Junction, Colorado  
Anne Arundel Medical Center, Annapolis Oncology CenterAnnapolis, Maryland  
Saint Joseph Oncology, Inc.Saint Joseph, Missouri  
Center for Cancer and Blood Disorders, PCFort Worth, Texas  
Saint Jude Heritage HealthcareFullerton, California  
Central Coast Medical Oncology CorpSanta Maria, California  
Suburban Hematology Oncology Associates, PCLawrenceville, Georgia  
Research Foundation of State University of New YorkSyracuse, New York  
The Stamford HospitalStamford, Connecticut  06902
San Jose Medical GroupSan Jose, California  95116
PinnacleHealthHarrisburg, Pennsylvania  17109
San Antonio Military Medical CenterFort Sam Houston, Texas  78234
Providence Saint Joseph Medical Center-Disney Family Cancer CenterBurbank, 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 CountyOrange, California  
Yale University Smilow Cancer HospitalNew Haven, Connecticut  06520
New York University Clincial Cancer CenterNew York, New York  10016
University of Pittsburgh Medical Center, Cancer CentersPittsburgh, Pennsylvania