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NCT05827055 · ClinicalTrials.gov registry record · Phase 2
Proglumide and Chemotherapy for Metastatic Pancreatic Cancer
A Phase 2 study of Metastatic Pancreatic Cancer, sponsored by Georgetown University.
- Active
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT05827055: Active Phase 2 study of Metastatic Pancreatic Cancer, sponsored by Georgetown University.
NCT05827055 is a Phase 2 study of Metastatic Pancreatic Cancer that is active but no longer recruiting, run by Georgetown University. The registered enrollment target is 30 participants, below the 106-participant average among 32 other Metastatic Pancreatic Cancer trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05827055, a Phase 2 study of Metastatic Pancreatic Cancer, is active but no longer recruiting, sponsored by Georgetown University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase 2 study with an open labelled lead-in study to approximately treat 30 patients \[6 subjects for Lead-in and 24 for Phase 2\] enrolled with metastatic pancreatic cancer with combination therapy using standard of care first line therapy with GEM-NAB-P (GEM 1000mg/m2 IV and NAB-P 125 mg/m2 given days 1, 8, and 15 every 28 days, and proglumide will be tested at the daily dose of 1200 mg orally given as 400 mg po TID. The lead-in study will determine the safety and tolerability of the 1200 mg daily dose of proglumide with standard of care GEM-NAB-P. If 0 or 1 of a total of 6 patients at 400mg experiences a DLT, then we will proceed to the Phase 2 randomized trial.
Primary Outcome
The number of abnormal serum chemistry values occurring in those on proglumide compared to those on placebo
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Gemcitabine
- DRUG Nab paclitaxel
- DRUG Proglumide
Study Locations (1)
District of Columbia
- Lombardi Comprehensive Cancer Center, Georgetown University - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2024-01-31 |
| Est. Completion | 2027-01 |
| Phase | Phase 2 |
What the registry record for NCT05827055 still lists
NCT05827055 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 106-participant average among 32 other Metastatic Pancreatic Cancer trials with a reported enrollment target (72% lower).
The record links to 1 condition, with Metastatic Pancreatic Cancer appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT05827055 reports a single indexed study location in District of Columbia.
Frequently Asked Questions
What is clinical trial NCT05827055 about?
NCT05827055 is a clinical study titled "Proglumide and Chemotherapy for Metastatic Pancreatic Cancer". This is a Phase 2 study with an open labelled lead-in study to approximately treat 30 patients \[6 subjects for Lead-in and 24 for Phase 2\] enrolled with metastatic pancreatic cancer with combination therapy using standard of care first line therapy with GEM-NAB-P (GEM 1000mg/m2 IV and NAB-P 125 mg...
What is the current status of trial NCT05827055?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2024-01-31. Estimated completion is 2027-01.
What conditions does trial NCT05827055 study?
This clinical trial studies the following conditions: Metastatic Pancreatic Cancer.
What interventions are being tested in trial NCT05827055?
The interventions under investigation include: Placebo (DRUG), Gemcitabine (DRUG), Nab paclitaxel (DRUG), Proglumide (DRUG).
Who is sponsoring clinical trial NCT05827055?
This trial is sponsored by Georgetown University, which has 227 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05827055 being conducted?
This trial has 1 study location across District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05827055's enrollment target sits among peer trials
30 17th of 32 higher than 10 of 32 other Metastatic Pancreatic Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Pancreatic Cancer 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.
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