Clinical trialNCT00912327CompletedObservational

Efficacy and Safety Study of Imprime PGG With Cetuximab in Subjects With Stage IV KRAS-Mutated Colorectal Cancer

SponsorHiberCell, Inc.Enrollment18Colorectal Cancer

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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).

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Leonard Saltz, MD
Memorial Sloane-Kettering Cancer Center
Principal InvestigatorKOL profile →
clinicaltrials.gov ↗
Neil H. Segal, MD, PhD
Memorial Sloane-Kettering Cancer Center
Principal Investigator
clinicaltrials.gov ↗
Neil Senzer, MD
Mary Crowley Medical Research Center
Principal Investigator
clinicaltrials.gov ↗
Purvi Gada, MD
University of Minnesota
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

3 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

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

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Odetiglucan

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 30 Jun 2009
Primary completion: 29 Feb 2012
Completion: 29 Feb 2012
Last update posted: 15 Feb 2012
Registered enrollment: 18
Registry id: NCT00912327

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.