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NCT00912327 · ClinicalTrials.gov registry record
Efficacy and Safety Study of Imprime PGG With Cetuximab in Subjects With Stage IV KRAS-Mutated Colorectal Cancer
A clinical trial, sponsored by HiberCell.
- Completed
- Registry status
- 18
- Enrollment target
NCT00912327 is a clinical trial that has completed, run by HiberCell. The registered enrollment target is 18 participants.
The verdict
NCT00912327 has completed, sponsored by HiberCell.
- COMPLETED
- Registry status
- 18 participants
- Enrollment target
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).
Interventions
- BIOLOGICAL Imprime PGG
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2009-06 |
| Est. Completion | 2012-02 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00912327
The ClinicalTrials.gov registry entry for NCT00912327 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is HiberCell, which has 11 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Imprime PGG is the first listed.
NCT00912327 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00912327 about?
NCT00912327 is a clinical study titled "Efficacy and Safety Study of Imprime PGG 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 col...
What is the current status of trial NCT00912327?
This trial is currently completed. The enrollment target is 18 participants. The study started on 2009-06. Estimated completion is 2012-02.
What interventions are being tested in trial NCT00912327?
The interventions under investigation include: Imprime PGG (BIOLOGICAL).
Who is sponsoring clinical trial NCT00912327?
This trial is sponsored by HiberCell, which has 11 total clinical trials registered on ClinicalTrials.gov.
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