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NCT02132403 · ClinicalTrials.gov registry record · Phase 1
(PM-01) IMPRIME PGG® With BTH1704 and Gemcitabine for Advanced Pancreatic Cancer
A Phase 1 study, sponsored by University of Illinois at Chicago.
- Terminated
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT02132403: Clinical Trial Phase 1 study, sponsored by University of Illinois at Chicago.
NCT02132403 is a Phase 1 study that was terminated before completion, run by University of Illinois at Chicago. The registered enrollment target is 3 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02132403, a Phase 1 study, was terminated before completion, sponsored by University of Illinois at Chicago.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
This Phase Ib dose escalation study will evaluate BTH1704, a monoclonal antibody that targets an aberrantly glycosylated antigen Mucin 1, and Imprime PGG, a glucan contained in yeast that is essential in triggering a leukocyte-mediated cytotoxic response towards tumor cells, in combination with gemcitabine in patients with advanced PDAC. The three intravenous drugs are taken in tandem 4 times in a 28-day cycle. The MAD of BTH1704 (BTH, 3 dose levels) in combination with gemcitabine (Gem) and Imprime PGG (I) will be determined using a standard "3+3" design. Treatment continues until disease progression, unacceptable toxicity, physician discretion, or patient refusal.
Primary Outcome
The primary objective of this Phase 1b study is to determine the maximal administered dose (MAD) of BTH1704 (Mucin-1 targeted antibody) in combination with gemcitabine and Imprime PGG (beta 1,3/1,6 glucan) when given to patients with advanced and previously treated pancreatic ductal adenocarcinoma (PDAC).
Interventions
- DRUG Gemcitabine
- DRUG BTH1704
- DRUG IMPRIME PGG
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2014-08 |
| Est. Completion | 2015-04 |
| Phase | Phase 1 |
Why NCT02132403 stopped before completion
NCT02132403 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 3 interventions - of which Gemcitabine is the first listed.
NCT02132403 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02132403 about?
NCT02132403 is a clinical study titled "(PM-01) IMPRIME PGG® With BTH1704 and Gemcitabine for Advanced Pancreatic Cancer". This Phase Ib dose escalation study will evaluate BTH1704, a monoclonal antibody that targets an aberrantly glycosylated antigen Mucin 1, and Imprime PGG, a glucan contained in yeast that is essential in triggering a leukocyte-mediated cytotoxic response towards tumor cells, in combination with gemc...
What is the current status of trial NCT02132403?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2014-08. Estimated completion is 2015-04.
What interventions are being tested in trial NCT02132403?
The interventions under investigation include: Gemcitabine (DRUG), BTH1704 (DRUG), IMPRIME PGG (DRUG).
Who is sponsoring clinical trial NCT02132403?
This trial is sponsored by University of Illinois at Chicago, which has 430 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02132403's enrollment target sits among peer trials
3 1999th of 2000 higher than 1 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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
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