Efficacy and Safety of GS-6624 With FOLFIRI as Second Line Treatment in Colorectal Adenocarcinoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01479465
First received: November 9, 2011
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

This randomized study compares the efficacy of GS-6624 versus placebo in combination with FOLFIRI (fluorouracil, leucovorin, and irinotecan) chemotherapy regimen in participants with metastatic KRAS or BRAF mutant colorectal cancer.


Condition Intervention Phase
Colorectal Cancer
Drug: GS-6624
Drug: FOLFIRI
Drug: Placebo to match GS-6624
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: Baseline to Month 20 ] [ Designated as safety issue: No ]
    Progression free survival (PFS) is measured as the time from date of randomization to the earliest (event) time of either death regardless of cause or first indication of disease progression.


Secondary Outcome Measures:
  • Overall survival [ Time Frame: Baseline to Month 20 ] [ Designated as safety issue: No ]
    Overall survival (OS) is measured as time from date of randomization to death regardless of cause.

  • Objective response rate [ Time Frame: Baseline to Month 20 ] [ Designated as safety issue: No ]
    Objective response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria (version 1.1) as Complete Response, Partial Response, Stable Disease, or Progressive Disease.


Estimated Enrollment: 265
Study Start Date: December 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GS-6624 700 mg and FOLFIRI (open-label)
Open-label, 28-day treatment period performed to assess the safety and tolerability prior to beginning the randomized part of the study; Participants will receive GS-6624 700 mg followed by FOLFIRI for one cycle and continue with 28-day treatment cycles during their entire participation.
Drug: GS-6624
GS-6624 200 mg or 700 mg administered intravenously biweekly
Drug: FOLFIRI
FOLFIRI administered intravenously biweekly
Experimental: GS-6624 200 mg and FORFIRI (randomized)
Randomized, double blind, placebo-controlled portion; Participants will receive 28-day treatment cycles of 200 mg GS-6624 followed by FOLFIRI for approximately 20 months.
Drug: GS-6624
GS-6624 200 mg or 700 mg administered intravenously biweekly
Drug: FOLFIRI
FOLFIRI administered intravenously biweekly
Experimental: GS-6624 700 mg and FOLFIRI (randomized)
Randomized, double blind, placebo-controlled portion; Participants will receive 28-day treatment cycles of 700 mg GS-6624 followed by FOLFIRI for approximately 20 months.
Drug: GS-6624
GS-6624 200 mg or 700 mg administered intravenously biweekly
Drug: FOLFIRI
FOLFIRI administered intravenously biweekly
Experimental: Placebo and FOLFIRI (randomized)
Randomized, double blind, placebo-controlled portion; Participants will receive 28-day treatment cycles of placebo to match GS-6624 followed by FOLFIRI for approximately 20 months.
Drug: FOLFIRI
FOLFIRI administered intravenously biweekly
Drug: Placebo to match GS-6624
Placebo to match GS-6624 administered intravenously biweekly

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  • Eastern Cooperative Oncology Group (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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01479465

  Hide Study Locations
Locations
United States, Alabama
Clearview Cancer Institute
Huntsville, Alabama, United States, 35801
United States, Arizona
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
United States, California
Central Hematology Oncology Medical Group, Inc.
Alhambra, California, United States
Comprehensive Blood and Cancer Center
Bakersfield, California, United States
Providence Saint Joseph Medical Center-Disney Family Cancer Center
Burbank, California, United States
Wilshire Oncology Medical Group, Inc.
Corona, California, United States
Saint Jude Heritage Healthcare
Fullerton, California, United States
University of California San Diego Medical Center
La Jolla, California, United States
Pacific Shores Medical Group
Long Beach, California, United States
UCLA Community Oncology Practice
Los Angeles, California, United States
TORI Network (Translational Oncology Research Intl)
Los Angeles, California, United States
Comprehensive Hematology Oncology Centers, Inc.
Los Angeles, California, United States
Stanford University Medical Center
Palo Alto, California, United States
Wilshire Oncology Medical Group, Inc.
Pomona, California, United States
Pacific Shores Medical Group
Redondo Beach, California, United States
Cancer Care Associates Medical Group
Redondo Beach, California, United States
Sharp Health Care
San Diego, California, United States
San Jose Medical Group
San Jose, California, United States
Central Coast Medical Oncology Corp
Santa Maria, California, United States
United States, Connecticut
Yale University Smilow Cancer Hospital
New Haven, Connecticut, United States, 06520
United States, District of Columbia
Georgetown University
Washington, District of Columbia, United States
United States, Florida
Florida Cancer Specialists
Gainesville, Florida, United States
MD Anderson Cancer Center
Orlando, Florida, United States
Florida Cancer Specialists
St. Petersburg, Florida, United States
United States, Georgia
Peachtree Hematology Oncology Consultants, PC
Atlanta, Georgia, United States
Suburban Hematology Oncology Associates, PC
Lawrenceville, Georgia, United States
United States, Illinois
Northwestern University
Chicago, Illinois, United States
United States, Indiana
Indiana University Simon Cancer Center
Indianapolis, Indiana, United States
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Tufts Medical Center
Boston, Massachusetts, United States, 02111
United States, Michigan
West Michigan Cancer Center
Kalamazoo, Michigan, United States
United States, Mississippi
Hematology and Oncology Associates at BridgePoint
Tupelo, Mississippi, United States
United States, Missouri
Saint Joseph Oncology, Inc.
Saint Joseph, Missouri, United States
United States, Montana
Montana Cancer Institute
Missoula, Montana, United States, 59802
United States, Nebraska
Southeast Nebraska Cancer Center
Lincoln, Nebraska, United States
United States, Nevada
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
United States, New York
New York University Clinical Cancer Center
New York, New York, United States, 10016
United States, Ohio
Oncology Hematology Care, Inc.
Cincinatti, Ohio, United States
Signal Point Clinical Research Center, LLC
Middletown, Ohio, United States
Oncology Hematology Care, Inc.
Wilmington, Ohio, United States
United States, Oregon
Kaiser Permanente Northwest Region Oncology Hematology
Portland, Oregon, United States
United States, South Carolina
South Carolina Oncology Associates
Columbia, South Carolina, United States
United States, Tennessee
Tennessee Oncology, PLLC
Nashville, Tennessee, United States
United States, Texas
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States
Center for Cancer and Blood Disorders, PC
Fort Worth, Texas, United States
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, United States
Scott & White Memorial
Temple, Texas, United States, 76508
The Center for Cancer and Blood Disorders
Weatherford, Texas, United States
United States, Utah
Utah Cancer Specialists
Salt Lake City, Utah, United States
Intermountain Healthcare
St. George, Utah, United States
United States, Virginia
Virginal Cancer Specialists, PC
Fairfax, Virginia, United States, 22033
Virginia Cancer Institute
Midlothian, Virginia, United States
Virginia Cancer Institute
Richmond, Virginia, United States
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States
France
Centre Hospitalier Universitaire Estaing
Clermont Ferrand, Auvergne, France, 63003
Centre Eugène Marquis
Rennes Cedex, Bretagne, France, 35042
Centre Georges François Leclerc
Dijon, France
Centre Oscar Lambret, Dept. de Cancerologie Digestive et Urologique
Lille Cedex, France
Centre Hospitalier Régional Universitaire Hôpital Saint Eloi
Montpellier Cedex 5, France
Centre Antoine Lacassagne
Nice Cedex 2, France
Institut Paoli Calmettes Centre Régional de Lutte Contre le Cancer
Rennes Cedex, France
Hôpital Trousseau - Service de Gastroenterologie
Tours, France
Germany
Universitätsklinikum Ulm
Ulm, Baden-Wuerttemberg, Germany, 89081
Universitätsklinikums Mannheim
Mannheim, Baden-Wuerttenberg, Germany, 68167
Ludwig-Maximilians-Universität München Klinikum Großhadern
München, Bayern, Germany, 81377
Universitätsklinikum Rostock
Rostock, Mecklenburg-Vorpommern, Germany, 18055
Klinikum Region Hannover GmbH, Krankenhaus Siloah
Hannover, Niedersachsen, Germany, 30449
Medizinische Universitätsklinik Bochum
Bochum, Nordrhein-Westfalen, Germany, 44892
Universitätsklinikum Essen
Essen, Nordrhein-Westfalen, Germany, 45122
Krankenanstalt Mutterhaus der Borromäerinnen e.V.
Trier, Rheinland-Pfalz, Germany, 54290
Universitätsklinikum Dresden
Dresden, Sachsen, Germany, 01307
Universitätsklinikum der Friedrich-Schiller-Universität Jena
Jena, Thuringen, Germany, 07747
Städtisches Klinikum Frankfurt-Höchst
Frankfurt, Germany
Katholisches Marienkrankenhaus gGmbH
Hamburg, Germany, 22045
University Magdeburg
Magdeburg, Germany
Italy
Ospedale Unico Versilia
Lido di Camaiore, Lucca, Italy, 55043
Azienda Ospedaliera San Gerardo di Monza
Monza, Monza e Brianza, Italy, 20052
Arcispedale Santa Maria Nuova IRCCS
Reggio Emilia, Reggio Nella Emilia, Italy, 42100
Ospedale Niguarda Cà Granda
Milano, Italy, 20162
Istituto Europeo di Oncologia
Milano, Italy, 20141
Ospedale Civile SS Annunziata ASL 1
Sassari, Italy, 07100
Poland
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie, Spólka z o. o.
Kraków, Malopolskie, Poland, 31-826
Uniwersyteckie Centrum Kliniczne
Gdansk, Pomorskie, Poland, 80-952
Olsztynski Osrodek Onkologiczny "Kopernik" sp. z o. o.
Olsztyn, Warminsko-Mazurskie, Poland, 10-513
Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy
Bydgoszcz, Poland
Centralny Szpital Kliniczny MSWiA
Warszawa, Poland
Centrum Onkologii - Instytut im Marii Sklodowskiej-Curie
Warszawa, Poland
Russian Federation
State Institution of Healthcare "Arkhangelsk Regional Clinical Oncology Dispensary"
Arkhangelsk, Russian Federation
Republican Clinical Oncologic Dispensary of Ministry of health of Republic Tatarstan
Kazan, Russian Federation
Kursk Regional Oncologic Dispensary
Kursk, Russian Federation
Cancer Research Center n.a. Blokhin, Chemotherapy Dept.
Moscow, Russian Federation
State Institution "Blokhin Cancer Research Centre RAMS"
Moscow, Russian Federation
Non-State Institution of healthcare "Central Clinical Hospital #1 OAO RZD"
Moscow, Russian Federation
Nizhny Novgorod City Oncology Dispensary
Nizhny Novgorod, Russian Federation
State Healthcare Institution of Omsk Region "Clinical Oncologic Dispensary"
Omsk, Russian Federation
N.N.Petrov Research Institute of Oncology
Saint Petersburg, Russian Federation
Spain
Centro Oncológico Regional de Galicia
A Coruña, La Coruna, Spain, 15009
Hospital Nuestra Señora de Sonsoles
Avila, Spain, 05004
Hospital Universitario Vall d'Hebron
Barcelona, Spain, 08035
Hospital Universitario de Girona Doctor Josep Trueta
Gerona, Spain, 17007
Hospital Universitario La Paz
Madrid, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034
Instituto de Investigación Sanitaria
Madrid, Spain
Hospital Clinico Universitario San Carlos
Madrid, Spain, 28040
Centro Integral Oncológico Clara Campal, Hospital de Madrid Norte-San Chinarro
Madrid, Spain, 28050
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Hospital Clinico Universitario de Valencia
Valencia, Spain, 46010
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Zung Thai, MD Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01479465     History of Changes
Other Study ID Numbers: GS-US-295-0203, 2011-003754-61
Study First Received: November 9, 2011
Last Updated: March 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
GSI
Gilead
Gilead Sciences
GS-6624
Colorectal Cancer
KRAS
Oncology
monoclonal antibody

Additional relevant MeSH terms:
Adenocarcinoma
Colorectal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on July 20, 2014