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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 is a Phase 1 study that was terminated before completion, run by University of Illinois at Chicago. The registered enrollment target is 3 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02132403
The ClinicalTrials.gov registry entry for NCT02132403 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Illinois at Chicago, which has 430 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Gemcitabine is the first listed.
NCT02132403 reports 0 study locations.
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.
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