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NCT05254171 · ClinicalTrials.gov registry record · Phase 2
Study of Nab-Paclitaxel and Gemcitabine With or Without SBP-101 in Pancreatic Cancer
A Phase 2 study of Pancreatic Ductal Adenocarcinoma and Pancreatic Cancer Metastatic, sponsored by Panbela Therapeutics.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 600
- Enrollment target
- 20
- Study locations
NCT05254171: Recruiting Phase 2 study of Pancreatic Ductal Adenocarcinoma and Pancreatic Cancer Metastatic, sponsored by Panbela Therapeutics.
NCT05254171 is a Phase 2 study of Pancreatic Ductal Adenocarcinoma and Pancreatic Cancer Metastatic that is actively recruiting participants, run by Panbela Therapeutics. The registered enrollment target is 600 participants, roughly in line with the 594-participant average among 84 other Pancreatic Ductal Adenocarcinoma trials with a reported enrollment target. The trial reports 20 study locations across 18 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05254171, a Phase 2 study of Pancreatic Ductal Adenocarcinoma and Pancreatic Cancer Metastatic, is actively recruiting participants, sponsored by Panbela Therapeutics.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 600 participants
- Enrollment target
- 20
- Study locations
Study Summary
The study is a randomized, double-blind, placebo-controlled, multicenter study of standard treatment with nab-paclitaxel and gemcitabine with or without SBP-101 in subjects previously untreated for metastatic pancreatic ductal adenocarcinoma (PDA), including subjects who have received prior neoadjuvant or adjuvant treatment.
Primary Outcome
Compare OS between subjects who receive SBP-101 and those who do not receive SBP-101 (i.e., placebo) in combination with nab-paclitaxel and gemcitabine
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Gemcitabine
- DRUG Nab-paclitaxel
- DRUG SBP-101
Study Locations (20)
New York
- Columbia University Medical Center - New York
- University of Rochester - Rochester
Washington
- Medical Oncology Associates - Spokane - Spokane
- MultiCare Regional Cancer Center - Tacoma - Tacoma
Arkansas
- Genesis Cancer and Blood Institute (SCRI) - Hot Springs
California
- Providence Medical Foundation - Fullerton
Connecticut
- Yale Cancer Center - New Haven
District of Columbia
- MedStar Georgetown University Hospital - Washington D.C.
Michigan
- Henry Ford Health System - Detroit
Minnesota
- CentraCare Health - Saint Cloud
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2022-08-08 |
| Est. Completion | 2027-01-01 |
| Phase | Phase 2 |
What NCT05254171 shows while recruiting
NCT05254171 is an interventional study that assigns participants to a tested intervention. The registered 600 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 594-participant average among 84 other Pancreatic Ductal Adenocarcinoma trials with a reported enrollment target.
The record links to 3 conditions, with Pancreatic Ductal Adenocarcinoma appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT05254171 names 20 study sites across 18 states, led by New York, Washington, Arkansas.
Frequently Asked Questions
What is clinical trial NCT05254171 about?
NCT05254171 is a clinical study titled "Study of Nab-Paclitaxel and Gemcitabine With or Without SBP-101 in Pancreatic Cancer". The study is a randomized, double-blind, placebo-controlled, multicenter study of standard treatment with nab-paclitaxel and gemcitabine with or without SBP-101 in subjects previously untreated for metastatic pancreatic ductal adenocarcinoma (PDA), including subjects who have received prior neoadjuv...
What is the current status of trial NCT05254171?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 600 participants. The study started on 2022-08-08. Estimated completion is 2027-01-01.
What conditions does trial NCT05254171 study?
This clinical trial studies the following conditions: Pancreatic Ductal Adenocarcinoma, Pancreatic Cancer Metastatic, Pancreatic Cancer Stage IV.
What interventions are being tested in trial NCT05254171?
The interventions under investigation include: Placebo (OTHER), Gemcitabine (DRUG), Nab-paclitaxel (DRUG), SBP-101 (DRUG).
Who is sponsoring clinical trial NCT05254171?
This trial is sponsored by Panbela Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05254171 being conducted?
This trial has 20 study locations across Arkansas, California, Connecticut, District of Columbia, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05254171's enrollment target sits among peer trials
600 11th of 84 higher than 73 of 84 other Pancreatic Ductal Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pancreatic Ductal Adenocarcinoma 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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