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NCT01309126 · ClinicalTrials.gov registry record · Phase 3
Study of Imprime PGG® in Combination With Cetuximab in Subjects With Recurrent or Progressive KRAS Wild Type Colorectal Cancer
A Phase 3 study, sponsored by HiberCell.
- Terminated
- Registry status
- Phase 3
- Development phase
- 217
- Enrollment target
NCT01309126 is a Phase 3 study that was terminated before completion, run by HiberCell. The registered enrollment target is 217 participants.
The verdict
NCT01309126, a Phase 3 study, was terminated before completion, sponsored by HiberCell.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 217 participants
- Enrollment target
Study Summary
Study BT-CL-PGG-CRC1031 is a Phase 3, open-label, randomized, multi-center study. Qualified subjects, who have KRAS wild type (WT) colorectal cancer will be randomized in a 2:1 ratio to treatment with either Imprime PGG and cetuximab or cetuximab alone. Subjects will be dosed until progression or discontinuation for some other reason. Efficacy will be assessed via Response Evaluation Criteria in Early Tumors 1.1 (RECIST 1.1); computed tomography (CT) scans will be conducted every 6 weeks. Safety, pharmacokinetics (PK), quality of life, and biomarker parameters will also be assessed.
Interventions
- DRUG Cetuximab
- BIOLOGICAL Imprime PGG + cetuximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 217 participants |
| Start Date | 2011-04 |
| Est. Completion | 2017-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01309126
The ClinicalTrials.gov registry entry for NCT01309126 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 217 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 2 interventions - of which Cetuximab is the first listed.
NCT01309126 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01309126 about?
NCT01309126 is a clinical study titled "Study of Imprime PGG® in Combination With Cetuximab in Subjects With Recurrent or Progressive KRAS Wild Type Colorectal Cancer". Study BT-CL-PGG-CRC1031 is a Phase 3, open-label, randomized, multi-center study. Qualified subjects, who have KRAS wild type (WT) colorectal cancer will be randomized in a 2:1 ratio to treatment with either Imprime PGG and cetuximab or cetuximab alone. Subjects will be dosed until progression or di...
What is the current status of trial NCT01309126?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 217 participants. The study started on 2011-04. Estimated completion is 2017-02.
What interventions are being tested in trial NCT01309126?
The interventions under investigation include: Cetuximab (DRUG), Imprime PGG + cetuximab (BIOLOGICAL).
Who is sponsoring clinical trial NCT01309126?
This trial is sponsored by HiberCell, which has 11 total clinical trials registered on ClinicalTrials.gov.
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