A Phase 2 Efficacy and Safety, Open-label, Multicenter Study of Imprime PGG® Injection in Combination With Cetuximab in Subjects With Stage IV KRAS-Mutated Colorectal Cancer
Study BT-CL-PGG-CRC0821 is a Phase 2, open-label, multicenter, efficacy and safety study. It
will be conducted using a two-stage design with the intention of determining the initial
efficacy of Imprime PGG in combination with a monoclonal antibody (MAb; cetuximab) in the
treatment of KRAS-mutant colorectal cancer (CRC). Both stages will be conducted in subjects
with Stage IV CRC demonstrating the KRAS gene mutation. All subjects will receive Imprime
PGG at 4 mg/kg and standard doses of cetuximab; Imprime PGG and cetuximab will be
administered in 6-week cycles. Subjects will dose until progression of disease or
discontinuation from the study for other reasons; e.g., safety, non-compliance. The initial
cetuximab dose will be 400 mg/m2 on Cycle 1/Day1 and subsequent doses of cetuximab will be
250 mg/m2 weekly. Imprime PGG will be dosed weekly at 4 mg/kg. Tumor measurements and
determination of tumor responses for this study will be performed according to RECIST.
Approximately 56 subjects will be enrolled at three participating centers (17 into Stage 1
and 39 into Stage 2). Final results will be determined from combined Stage 1 and Stage 2
data.
Observational
Observational Model: Cohort, Time Perspective: Prospective
Objective response rate (ORR)
Assessed after 17 subjects complete 1 treatment cycle and at completion of study.
No
Leonard Saltz, MD
Principal Investigator
Memorial Sloane-Kettering Cancer Center
United States: Food and Drug Administration
BT-CL-PGG-CRC0821
NCT00912327
June 2009
February 2012
Name | Location |
---|---|
University of Minnesota | Minneapolis, Minnesota 55455 |
Mary Crowley Medical Research Center | Dallas, Texas 75246 |
Memorial Sloane-Kettering Cancer Research Center | New York, New York |