Spots Global Cancer Trial Database for Study of Imprime PGG® in Combination With Cetuximab in Subjects With Recurrent or Progressive KRAS Wild Type Colorectal Cancer
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Study of Imprime PGG® in Combination With Cetuximab in Subjects With Recurrent or Progressive KRAS Wild Type Colorectal Cancer
Official Title: A Phase 3 Open-Label, Randomized, Multicenter Study of Imprime PGG® in Combination With Cetuximab (Erbitux®) in Subjects With Recurrent or Progressive KRAS Wild Type Colorectal Cancer
Study ID: NCT01309126
Conditions
Study Description
Brief Summary: Study BT-CL-PGG-CRC1031 is a Phase 3, open-label, randomized, multi-center study. Qualified subjects, who have KRAS wild type (WT) colorectal cancer will be randomized in a 2:1 ratio to treatment with either Imprime PGG and cetuximab or cetuximab alone. Subjects will be dosed until progression or discontinuation for some other reason. Efficacy will be assessed via Response Evaluation Criteria in Early Tumors 1.1 (RECIST 1.1); computed tomography (CT) scans will be conducted every 6 weeks. Safety, pharmacokinetics (PK), quality of life, and biomarker parameters will also be assessed.
Detailed Description: Study BT-CL-PGG-CRC1031 is a Phase 3, open-label, randomized, multi-center study. Qualified subjects, who have KRAS WT colorectal cancer will be randomized in a 2:1 ratio to either: Arm 1: Imprime PGG and cetuximab or Arm 2: Cetuximab Approximately 795 subjects will be randomized into the study. Dosing will occur in 6-week cycles. Imprime PGG will be dosed at 4 mg/kg and will be administered weekly in each cycle (Weeks 1-6/Days 1, 8, 15, 22, 29, and 36) preceding the administration of cetuximab (Arm 1 only). The initial cetuximab dose (both arms) will be 400 mg/m2 on Cycle 1/Day 1 and subsequent doses will be 250 mg/m2 administered weekly in each cycle (Weeks 1-6/Days 1, 8, 15, 22, 29, and 36). Subjects will be dosed until progressive disease (PD) per RECIST 1.1 or discontinuation of study drug for other reasons; e.g., safety. Following completion of the treatment period of the study, subjects will be monitored for survival until death or loss to follow-up. Tumor measurements and determination of tumor responses will be evaluated according to RECIST 1.1. Safety, PK, quality of life, and biomarker parameters will also be assessed.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Northwest Alabama Cancer Center, Florence, Alabama, United States
Highlands Oncology Group, Bentonville, Arkansas, United States
Pacific Medical Center, Anaheim, California, United States
Comprehensive Blood and Cancer Center, Bakersfield, California, United States
Providence St. Joseph Medical Center, Burbank, California, United States
UCSD Moores Cancer Center, La Jolla, California, United States
Kenmar Research Institute, Los Angeles, California, United States
AMPM Research Clinic, Miami Gardens, Florida, United States
MD Anderson Cancer Center, Orlando, Florida, United States
University of Hawaii Cancer Center, Honolulu, Hawaii, United States
Medical and Surgical Specialists, Galesburg, Illinois, United States
Illinois Cancer Specialists, Niles, Illinois, United States
Indiana University Cancer Center, Beech Grove, Indiana, United States
University of Louisville/James Brown Cancer Center, Louisville, Kentucky, United States
Ochsner Clinic Foundation, New Orleans, Louisiana, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Henry Ford Health System, Detroit, Michigan, United States
University of Minnesota, Minneapolis, Minnesota, United States
Ellis Fischel Cancer Center at University of Missouri- Columbia, Columbia, Missouri, United States
Oncology Hematology West PC dba Nebraska Cancer Specialists, Omaha, Nebraska, United States
Hematology and Oncology Associates of Central NY, East Syracuse, New York, United States
New York Oncology, Hematology, P.C., Hudson, New York, United States
Signal Point Hematology/Oncology, Middletown, Ohio, United States
Toledo Community Oncology Program- Toledo Community Hospital, Toledo, Ohio, United States
Willamette Valley Cancer Institute and Research Center, Eugene, Oregon, United States
Providence Portland Medical Center, Portland, Oregon, United States
Cancer Centers of the Carolinas, Spartanburg, South Carolina, United States
The Jones Clinic, Germantown, Tennessee, United States
Tennessee Cancer Specialists, Knoxville, Tennessee, United States
Texas Oncology-Amarillo, Amarillo, Texas, United States
Mary Crowley Cancer Research Center, Dallas, Texas, United States
Texas Oncology - Dallas Presbyterian Hospital, Dallas, Texas, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
Texas Oncology Denton South, Denton, Texas, United States
Texas Oncology - Fort Worth, Fort Worth, Texas, United States
Texas Oncology - Lewisville, Lewisville, Texas, United States
Texas Oncology-Seton Williamson, Round Rock, Texas, United States
Cancer Care Centers of South Texas, San Antonio, Texas, United States
Texas Oncology - Sherman, Sherman, Texas, United States
Texas Oncology - Tyler, Tyler, Texas, United States
Northern Utah Associates, Ogden, Utah, United States
Virginia Oncology Associates, Newport News, Virginia, United States
Oncology and Hematology Associates of Southwest Virginia, Inc., dba Blue Ridge Cancer Care, Roanoke, Virginia, United States
Centre d' Oncologie de Gentilly, Nancy, , France
Medizinisches Versorgungszentrum Ãrzteforum Seestrabe, Berlin, , Germany
Ãrzteforum Henningsdorf Darmzentrum Oberhavel, Hennigsdorf, , Germany
Klinikum Kassel GmbH Medizinische Klinik IV Onkologie, Hämatologie, Immunologie, Kassel, Hessen, , Germany
Universitätsklinikum Köln - Studienzentrum der Klinik I für Innere Medizin, Koeln, Nordrhein Westfalen, , Germany
Schwerpunktpraxis für Hämatologie und Onkologie, Magdeburg, , Germany
Universitaetsklinikum Ulm, Ulm, , Germany
Petruskrankenhaus Wuppertal, Klinik fuer Innere Medizin II- Gastroenterologie, Hepatologie und Diabetologie, Wuppertal, , Germany
Fundacion de Investigacion de Diego, San Juan, , Puerto Rico
Contact Details
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
