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.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Centre d' Oncologie de Gentilly, Nancy 54000, France; Active, not recruiting
Medizinisches Versorgungszentrum Ãrzteforum Seestrabe, Berlin 13347, Germany; Recruiting
Nick Niles, Phone: (908)453-3317, Email: nniles@cmedresearch.com
Alexander Schmittel, MD, Principal Investigator
Ãrzteforum Henningsdorf Darmzentrum Oberhavel, Hennigsdorf 16761, Germany; Recruiting
Nick Niles, Phone: (908)453-3317, Email: nniles@cmedresearch.com
Andrea Speidel, MD, Principal Investigator
Klinikum Kassel GmbH Medizinische Klinik IV Onkologie, Hämatologie, Immunologie, Kassel, Hessen 34125, Germany; Recruiting
Nick Niles, Phone: (908)453-3317, Email: nniles@cmedresearch.com
Martin Wolf, Prof, MD, Principal Investigator
Universitätsklinikum Köln - Studienzentrum der Klinik I für Innere Medizin, Koeln, Nordrhein Westfalen 50937, Germany; Recruiting
Nick Niles, Phone: (908)453-3317, Email: nniles@cmedresearch.com
Thomas Zander, MD, Principal Investigator
Schwerpunktpraxis für Hämatologie und Onkologie, Magdeburg 39104, Germany; Recruiting
Nick Niles, Phone: (908)453-3317, Email: nniles@cmedresearch.com
Hendrik Kroening, MD, Principal Investigator
Universitaetsklinikum Ulm, Ulm 89081, Germany; Recruiting
Nick Niles, Phone: (908)453-3317, Email: nniles@cmedresearch.com
Thomas Ettrich, MD, Principal Investigator
Petruskrankenhaus Wuppertal, Klinik fuer Innere Medizin II- Gastroenterologie, Hepatologie und Diabetologie, Wuppertal 42283, Germany; Recruiting
Nick Niles, Phone: (908)453-3317, Email: nniles@cmedresearch.com
Andreas Erhardt, MD, Principal Investigator
Fundacion de Investigacion de Diego, San Juan 00927, Puerto Rico; Active, not recruiting
Northwest Alabama Cancer Center, Florence, Alabama 35630, United States; Recruiting
Nick Niles, Email: nniles@cmedresearch.com
Hemant Patel, MD, Principal Investigator
Highlands Oncology Group, Bentonville, Arkansas 72703, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
J. Thaddeus Beck, MD, Principal Investigator
Pacific Medical Center, Anaheim, California 92801, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Veena Charu, MD, Principal Investigator
Comprehensive Blood and Cancer Center, Bakersfield, California 93309, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Ravi Patel, MD, Principal Investigator
Providence St. Joseph Medical Center, Burbank, California 91505, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Gregg Olsen, MD, Principal Investigator
UCSD Moores Cancer Center, La Jolla, California 92903, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Tony Reid, MD, PhD, Principal Investigator
Kenmar Research Institute, Los Angeles, California 90057, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Merrill Shum, MD, Principal Investigator
AMPM Research Clinic, Miami Gardens, Florida 33169, United States; Recruiting
Nick Niles, Email: nniles@cmedresearch.com
Luis Villa Jr., MD, Principal Investigator
MD Anderson Cancer Center, Orlando, Florida 32806, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Sajeve Thomas, MD, Principal Investigator
University of Hawaii Cancer Center, Honolulu, Hawaii 96813, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Jared Acoba, MD, Principal Investigator
Medical and Surgical Specialists, Galesburg, Illinois 61401, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Diane Prager, MD, Principal Investigator
Illinois Cancer Specialists, Niles, Illinois 60714, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Leonard Klein, MD, Principal Investigator
Indiana University Cancer Center, Beech Grove, Indiana 46237, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Nadeem Ikhlaque, MD, Principal Investigator
University of Louisville/James Brown Cancer Center, Louisville, Kentucky 40202, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Vivek Sharma, MD, Principal Investigator
Ochsner Clinic Foundation, New Orleans, Louisiana 70121, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Jyotsna Fuloria, MD, Principal Investigator
Dana Farber Cancer Institute, Boston, Massachusetts 02115, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Jeffrey Meyerhardt, MD, MPH, Principal Investigator
Massachusetts General Hospital, Boston, Massachusetts 02114, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Jeffrey Meyerhardt, MD, MPH, Principal Investigator
Henry Ford Health System, Detroit, Michigan 48202, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Ira Wollner, MD, Principal Investigator
University of Minnesota, Minneapolis, Minnesota 55455, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Anne Blaes, MD, Principal Investigator
Ellis Fischel Cancer Center at University of Missouri- Columbia, Columbia, Missouri 65203, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Akm Mosharraf Hossain, MD, MPH, Principal Investigator
Oncology Hematology West PC dba Nebraska Cancer Specialists, Omaha, Nebraska 68130, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Ralph Hauke, MD, Principal Investigator
Hematology and Oncology Associates of Central NY, East Syracuse, New York 13057, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Benny Wong, MD, Principal Investigator
New York Oncology, Hematology, P.C., Hudson, New York 12534, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Linda DeMarco, MD, Principal Investigator
Signal Point Hematology/Oncology, Middletown, Ohio 45042, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Nandagopal Vrindavanam, MD, Principal Investigator
Toledo Community Oncology Program- Toledo Community Hospital, Toledo, Ohio 43623, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Rex B Mowat, MD, Principal Investigator
Willamette Valley Cancer Institute and Research Center, Eugene, Oregon 97401, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Glenn Buchanan, MD, Principal Investigator
Providence Portland Medical Center, Portland, Oregon 97213, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Todd Crocenzi, MD, Principal Investigator
Cancer Centers of the Carolinas, Spartanburg, South Carolina 29307, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Ki Y Chung, MD, Principal Investigator
The Jones Clinic, Germantown, Tennessee 38138, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Michael Jones, MD, Principal Investigator
Tennessee Cancer Specialists, Knoxville, Tennessee 37915, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Tracy Dobbs, MD, Principal Investigator
Texas Oncology-Amarillo, Amarillo, Texas 79106, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Leonardo Forero, MD, Principal Investigator
Mary Crowley Cancer Research Center, Dallas, Texas 75201, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
John Nemunaitis, MD, Principal Investigator
Texas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas, Texas 75246, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Andrew McCollum, MD, Principal Investigator
Texas Oncology - Dallas Presbyterian Hospital, Dallas, Texas 75231, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Kristi McIntyre, MD, Principal Investigator
Texas Oncology Denton South, Denton, Texas 76210, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Sharad Jain, MD, Principal Investigator
Texas Oncology - Fort Worth, Fort Worth, Texas 76104, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Robert Ruxer, Jr., MD, Principal Investigator
Texas Oncology - Lewisville, Lewisville, Texas 75067, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Derrick Nguyen, MD, Principal Investigator
Texas Oncology-Seton Williamson, Round Rock, Texas 78665, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Vivian Cline-Burkhardt, MD, Principal Investigator
Cancer Care Centers of South Texas, San Antonio, Texas 78217, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Allyson Harroff, MD, Principal Investigator
Texas Oncology - Sherman, Sherman, Texas 75090, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Tammy Roque, MD, Principal Investigator
Texas Oncology - Tyler, Tyler, Texas 75702, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Donald Richards, MD, Principal Investigator
Northern Utah Associates, Ogden, Utah 84403, United States; Active, not recruiting
Virginia Oncology Associates, Newport News, Virginia 23606, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
David Chang, MD, Principal Investigator
Oncology and Hematology Associates of Southwest Virginia, Inc., dba Blue Ridge Cancer Care, Roanoke, Virginia 24014, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Mark Kochenderfer, MD, Principal Investigator