Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Clinical Trial Phase 3 study, sponsored by HiberCell.
NCT01309126 is a Phase 3 study that was terminated before completion, run by HiberCell. The registered enrollment target is 217 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
Why NCT01309126 stopped before completion
NCT01309126 is an interventional study that assigns participants to a tested intervention. The registered 217 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 2 interventions - of which Cetuximab is the first listed.
NCT01309126 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01309126's enrollment target sits among peer trials
217 1332nd of 2000 higher than 669 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05079282 · 217 participants · Phase 1
Study of ONO-4685 in Patients With Relapsed or Refractory T Cell Lymphoma
- NCT05470439 · 217 participants · NA
My Interprofessional Care Team for Adherence and Research Engagement Disparities
- NCT05981703 · 217 participants · Phase 1
A Study Investigating BGB-26808 Alone or in Combination With Tislelizumab in Participants With Advanced Solid Tumors
- NCT06342258 · 217 participants · Phase 1
COES: Curing Order Effects on Sealants
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia