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A First-in-Human Study to Evaluate Implantable Iontophoresis Chemotherapy Delivery Device With Gemcitabine Once Weekly or Twice Weekly in Participants With Pancreatic Cancer

RecruitingPhase 1Ages 18 Years - anyAllContinuity Biosciences, LLC
NCT07481383 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 m

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📋 Eligibility rules (as published)
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.
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What it tests

  • ACT Implantable Iontophoresis Chemotherapy Delivery Device with Gemcitabine (ACT-IOP-003)
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Where

2 sites
University of Michigan Health
Ann Arbor, United States
West Virginia University
Morgantown, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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