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

NCT00912327 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 18

Last updated 2012-02-15

No results posted yet for this study

Summary

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).

Conditions

Interventions

BIOLOGICAL

Imprime PGG

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

Sponsors & Collaborators

  • HiberCell, Inc.

    lead INDUSTRY

Principal Investigators

  • 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

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00912327 on ClinicalTrials.gov