Actively Recruiting
A First-in-Human Study to Evaluate Implantable Iontophoresis Chemotherapy Delivery Device With Gemcitabine Once Weekly or Twice Weekly in Participants With Pancreatic Cancer
Led by Continuity Biosciences, LLC · Updated on 2026-05-01
12
Participants Needed
2
Research Sites
85 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A First-in-Human Study to Evaluate Implantable Iontophoresis Chemotherapy Delivery Device With Gemcitabine Once Weekly or Twice Weekly in Participants With Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eastern Cooperative Oncology Group (ECOG) performance status 64 1
- Diagnosis of nonmetastatic, nonresectable pancreatic adenocarcinoma confirmed by CT or MRI within the last 12 weeks
- Diagnosis of borderline or locally advanced pancreatic adenocarcinoma confirmed as nonresectable during exploratory surgery
- Prior treatment with standard of care/neoadjuvant chemotherapy including FOLFIRINOX or GEM Abraxane for current pancreatic cancer diagnosis
You will not qualify if you...
- Current severe or critical pancreatitis
- Previous radiation treatment for pancreatic cancer
- Evidence of metastatic pancreatic cancer or any other cancer on CT or MRI screening
- History of cardiovascular disease affecting heart function
- Presence of any metal implants
AI-Screening
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Trial Site Locations
Total: 2 locations
1
University of Michigan Health
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
2
West Virginia University
Morgantown, West Virginia, United States, 26506
Actively Recruiting
Research Team
N
Nancy A Sacco, PhD
CONTACT
A
Allison Marquette
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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