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 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.
Interventional
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Survival (OS)
18 months
No
United States: Food and Drug Administration
BT-CL-PGG-CRC1031
NCT01309126
April 2011
September 2014
Name | Location |
---|---|
Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |
Virginia Oncology Associates | Newport News, Virginia 23606 |
Cancer Centers of the Carolinas | Greenville, South Carolina 29605 |
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
Carle Cancer Center | Urbana, Illinois 61801 |
Comprehensive Blood and Cancer Center | Bakersfield, California 93309 |
University of Minnesota | Minneapolis, Minnesota 55455 |
Highlands Oncology Group | Springdale, Arkansas 72764 |
Tennessee Cancer Specialists | Knoxville, Tennessee 37920 |
Kenmar Research Institute | Los Angeles, California 90057 |
Northern Utah Associates | Ogden, Utah 84403 |
Henry Ford Health System | Detroit, Michigan 48202 |
Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
Providence Portland Medical Center | Portland, Oregon 97213-3635 |
Providence St. Joseph Medical Center | Burbank, California 91505 |
UCSD Moores Cancer Center | La Jolla, California 93093 |
The Jones Clinic | Germantown, Tennessee 38138 |
Medical and Surgical Specialists | Galesburg, Illinois 61401 |
Puget Sound Cancer Centers | Edmonds, Washington 98026 |
Cancer Care Centers of South Texas | San Antonio, Texas 78229 |
Signal Point Hematology/Oncology | Middletown, Ohio 45042 |
Texas Oncology-Seton Williamson | Round Rock, Texas 78665 |
Mary Crowley Cancer Research Center | Dallas, Texas 75246 |
Willamette Valley Cancer Institute and Research Center | Springfield, Oregon 97477 |
Texas Oncology - Tyler | Tyler, Texas 75702 |
University of Hawaii Cancer Center | Honolulu, Hawaii 96813 |
Illinois Cancer Specialists | Niles, Illinois 60714 |
Texas Oncology - Fort Worth | Fort Worth, Texas 76104 |
Texas Oncology - Lewisville | Lewisville, Texas 75067 |
Texas Oncology - Dallas Presbyterian Hospital | Dallas, Texas 75231 |
Texas Oncology - Baylor Charles A. Sammons Cancer Center | Dallas, Texas 75246 |
Texas Oncology - Sherman | Sherman, Texas 75090-0504 |
Pacific Medical Center | San Francisco, California |
National Institute of Clinical Research (Lalita Pandit, MN Inc.) | Fountain Valley, California 92708 |
University of Louisville/James Brown Cancer Center | Louisville, Kentucky 40202 |
Ellis Fischel Cancer Center at University of Missouri- Columbia | Columbia, Missouri 65203 |
Gabrail Cancer Centr Research | Canton, Ohio 44718 |
Toledo Community Oncology Program- Toledo Community Hospital | Toledo, Ohio 43623 |
Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care | Salem, Virginia 24153 |
Oncology Hematology West PC dba Nebraska Cancer Specialists | Omaha, Nebraska 68130 |
New York Oncology, Hematology, P.C. | Hudson, New York 12534 |
Texas Oncology-Amarillo | Amarillo, Texas 79106 |