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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: Completed study, sponsored by HiberCell.
NCT00912327 is a clinical trial that has completed, run by HiberCell. The registered enrollment target is 18 participants. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00912327 record still lists
NCT00912327 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 18 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Imprime PGG is the first listed.
NCT00912327 does not publish any study locations in the registry export this page uses.
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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