Implantable iontophoresis device to deliver gemcitabine directly to pancreatic tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first-in-human, phase 1 trial tests an implantable iontophoresis device (ACT-IOP-003) that is surgically placed on the pancreas to deliver gemcitabine once or twice weekly. Participants complete 4 weeks of screening, 8 weeks of treatment, and 12 weeks of follow-up, with serial blood, urine, and stool sampling and at least three CT scans to monitor safety, drug levels, and tumor response. The primary focus is safety, tolerability, and pharmacokinetics (gemcitabine concentrations before and after treatment), with secondary interest in tumor response and whether systemic side effects are reduced compared with intravenous delivery. Enrollment targets people with nonmetastatic, locally advanced, nonresectable pancreatic adenocarcinoma who have previously received standard neoadjuvant chemotherapy.

Why it matters

Who can join: the full rules

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.
* Initial diagnosis of borderline or locally advanced pancreatic adenocarcinoma confirmed as being nonresectable at the time of exploratory laparoscopic and/ or open surgery.
* Previously received prior standard of care/neoadjuvant chemotherapy of FOLFIRINOX or GEM Abraxane for their current diagnosis of pancreatic cancer.

Exclusion Criteria:

* Current pancreatitis classified as severe or critical.
* Prior radiation treatment as part of standard of care/neoadjuvant treatment for pancreatic cancer.
* Evidence of metastatic pancreatic cancer or any other type of cancer upon screening of through CT/MRI.
* Any medical history of past or present cardiovascular disease related to heart function.
* Any metal implants.

Note: Other inclusion/exclusion criteria apply.

Where it's running

• University of Michigan Health
  Ann Arbor, Michigan, United States Recruiting
• West Virginia University
  Morgantown, West Virginia, United States Recruiting

Study contacts

• Study coordinator: Allison Marquette
• Email: allison@continuitybiosciences.com
• Phone: 619-341-2232

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.