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
Sponsor study identifier
observational
18
1 country
3
Study Start
June 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2012
Actual (reported)Study Completion
February 2012
Actual (reported)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. Subjects will dose until progression of disease or discontinuation from the study for other reasons; e.g., safety, non-compliance. Approximately 56 subjects will be enrolled at three participating centers (17 into Stage 1 and 39 into Stage 2).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2012
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2009
Date type not reportedThis date has not been verified as actual or estimated.
June 1, 2009
Actual (reported)June 3, 2009
Actual (reported)February 2012
Actual (reported)February 2012
Actual (reported)Objective response rate (ORR)
Assessed after 17 subjects complete 1 treatment cycle and at completion of study.
Disease control rate (DCR) and duration of disease control
Assessed after 17 subjects complete 1 treatment cycle and at completion of study.
Complete response (CR), partial response (PR), and stable disease (SD) rates
Assessed after 17 subjects complete 1 treatment cycle and at completion of study.
Duration of objective tumor response
Assessed after 17 subjects complete 1 treatment cycle and at completion of study.
Duration of stable disease
Assessed after 17 subjects complete 1 treatment cycle and at completion of study.
Time to progression (TTP)
Assessed after 17 subjects complete 1 treatment cycle and at completion of study.
Imprime PGG, 4 mg/kg, i.v. over 2 hr, weekly in 6 week cycles and Cetuximab, initial dose will be 400 mg/m2 via i.v., and subsequent doses will be 250 mg/m2 via i.v., weekly in 6 week cycles
Approximately 56 patients with Stage IV Kras-mutated colorectal cancer.
University of Minnesota
Minneapolis, Minnesota, United States
Memorial Sloane-Kettering Cancer Research Center
New York, New York, United States
Mary Crowley Medical Research Center
Dallas, Texas, United States
Tumor tissue samples from previous biopsies and blood plasma will be collected.
Leonard Saltz, MD
Memorial Sloane-Kettering Cancer Center
Neil H. Segal, MD, PhD
Memorial Sloane-Kettering Cancer Center
Neil Senzer, MD
Mary Crowley Medical Research Center
Purvi Gada, MD
University of Minnesota
18 participants (actual enrollment reported by the registry).
First Submitted
June 1, 2009
First Posted
June 3, 2009
Study Start
June 2009
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
February 2012
Actual (reported)Study Completion
February 2012
Actual (reported)Last Updated
February 15, 2012
Record last verified: 2012-02
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Source: ClinicalTrials.gov.
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