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NCT07481383 · ClinicalTrials.gov registry record · Phase 1
A First-in-Human Study to Evaluate Implantable Iontophoresis Chemotherapy Delivery Device With Gemcitabine Once Weekly or Twice Weekly in Participants With Pancreatic Cancer
A Phase 1 study of Pancreatic Adenocarcinoma Non-resectable, sponsored by Continuity Biosciences.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT07481383: Recruiting Phase 1 study of Pancreatic Adenocarcinoma Non-resectable, sponsored by Continuity Biosciences.
NCT07481383 is a Phase 1 study of Pancreatic Adenocarcinoma Non-resectable that is actively recruiting participants, run by Continuity Biosciences. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07481383, a Phase 1 study of Pancreatic Adenocarcinoma Non-resectable, is actively recruiting participants, sponsored by Continuity Biosciences.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is being done to find out if delivering gemcitabine using the ACT-IOP-003 device directly to the area where the tumor is in the pancreas is safe and tolerable. The main questions the study aims to answer are: * Is ACT-IOP-003 safe and tolerable when given to patients with nonmetastatic, locally advanced, nonresectable pancreatic cancer. * How much study drug (gemcitabine) is found in the blood before and after treatment. * If the tumor responds to treatment. * If the gemcitabine side effects are less than seen when delivered intravenously (IV). Study participants will: * Have the study device surgically placed on the pancreas at the beginning of the study. * Complete 8 weeks of treatment with a 4 week screening period and 12 weeks of follow-up for a total of 24 weeks of participation in the study. * Give blood, urine, and stool samples to monitor safety and determine how much of the study drug (gemcitabine) is in the blood. * Have imaging (CT) done at least three times during the study.
Primary Outcome
Incidence of adverse events (AEs), serious adverse events (SAEs), drug- or device-related AEs, and dose-limiting toxicities (DLTs)
Conditions Studied
Interventions
- COMBINATION_PRODUCT ACT Implantable Iontophoresis Chemotherapy Delivery Device with Gemcitabine (ACT-IOP-003)
Study Locations (1)
West Virginia
- West Virginia University - Morgantown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2026-03-11 |
| Est. Completion | 2027-11-01 |
| Phase | Phase 1 |
What NCT07481383 shows while recruiting
NCT07481383 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 1 condition, with Pancreatic Adenocarcinoma Non-resectable appearing as the primary indexed condition, and to 1 intervention - of which ACT Implantable Iontophoresis Chemotherapy Delivery Device with Gemcitabine (ACT-IOP-003) is the first listed.
NCT07481383 reports a single indexed study location in West Virginia.
Frequently Asked Questions
What is clinical trial NCT07481383 about?
NCT07481383 is a clinical study titled "A First-in-Human Study to Evaluate Implantable Iontophoresis Chemotherapy Delivery Device With Gemcitabine Once Weekly or Twice Weekly in Participants With Pancreatic Cancer". This study is being done to find out if delivering gemcitabine using the ACT-IOP-003 device directly to the area where the tumor is in the pancreas is safe and tolerable. The main questions the study aims to answer are: * Is ACT-IOP-003 safe and tolerable when given to patients with nonmetastatic,...
What is the current status of trial NCT07481383?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2026-03-11. Estimated completion is 2027-11-01.
What conditions does trial NCT07481383 study?
This clinical trial studies the following conditions: Pancreatic Adenocarcinoma Non-resectable.
What interventions are being tested in trial NCT07481383?
The interventions under investigation include: ACT Implantable Iontophoresis Chemotherapy Delivery Device with Gemcitabine (ACT-IOP-003) (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT07481383?
This trial is sponsored by Continuity Biosciences, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07481383 being conducted?
This trial has 1 study location across West Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07481383's enrollment target sits among peer trials
12 1853rd of 2000 higher than 90 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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