A First-in-Human Study to Evaluate Implantable Iontophoresis Chemotherapy Delivery Device With Gemcitabine Once Weekly or Twice Weekly in Participants With Pancreatic Cancer
Recruiting
Phase 1
Interventional Study
Pancreatic Adenocarcinoma Non-resectable
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 12 (estimated)
- Sponsor
- Continuity Biosciences, LLC · Industry
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About This Trial
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 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
* Diagnosis of nonmetastatic, nonresectable pancreatic adenocarcinoma as evident on initial study. screening computed tomography (CT) or magnetic resonance imaging (MRI) or previous scan within the last 12 weeks…
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