Actively Recruiting
A First-in-Human Study to Evaluate Safety and Pharmacokinetics of ACT Implantable Iontophoresis Device Delivering Gemcitabine Once or Twice Weekly After Chemotherapy in Nonresectable Pancreatic Cancer
Led by Continuity Biosciences, LLC · Updated on 2026-05-01
12
Participants Needed
2
Research Sites
13 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are investigating the safety and tolerability of delivering gemcitabine chemotherapy directly to the pancreas using the ACT-IOP-003 implantable iontophoresis device in patients with locally advanced, nonresectable pancreatic adenocarcinoma. The study aims to understand if this delivery method is safe, how much gemcitabine enters the bloodstream before and after treatment, how the tumor responds, and whether side effects are reduced compared to intravenous delivery. Participants will have the ACT-IOP-003 device surgically implanted on the pancreas. They will receive gemcitabine treatment either once weekly or twice weekly via the device for eight weeks. The study includes a 4-week screening period before treatment and a 12-week follow-up after treatment, totaling about 24 weeks of participation. During the study, participants will provide blood, urine, and stool samples to monitor safety and measure gemcitabine levels. Imaging scans such as CT will be performed at least three times to assess tumor status. Researchers will monitor adverse events closely from screening through week 20, focusing on safety, tolerability, and determining the maximum tolerated dose of the drug delivered by the device.
CONDITIONS
Brief 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 of 0 or 1
- Diagnosis of nonmetastatic, nonresectable pancreatic adenocarcinoma confirmed by CT or MRI within the last 12 weeks
- Initial diagnosis of borderline or locally advanced pancreatic adenocarcinoma confirmed as nonresectable during surgery
- Prior treatment with standard chemotherapy FOLFIRINOX or GEM Abraxane for current pancreatic cancer
You will not qualify if you...
- Severe or critical pancreatitis at the time of screening
- Prior radiation treatment for pancreatic cancer
- Evidence of metastatic pancreatic cancer or other cancers on screening scans
- History of cardiovascular disease related to heart function
- Presence of any metal implants in the body
- Other unspecified exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants receive gemcitabine delivered via the ACT implantable iontophoresis device once or twice weekly for 8 weeks.
Once or twice weekly visits for 8 weeks depending on cohort assignment
Duration - Up to 12 weeks after treatment
Participants are monitored for safety, tolerability, and maximum tolerated dose through adverse event reporting up to Week 20.
Regular follow-up visits up to Week 20
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
A
Allison Marquette
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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