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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
5 + 1 (modified 3 +3 design)
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cohort 1: ACT-IOP-003 Once Weekly 		Gemcitabine treatment delivered via the ACT-IOP-003 study device once weekly for 8 weeks
  • Combination Product: ACT Implantable Iontophoresis Chemotherapy Delivery Device with Gemcitabine (ACT-IOP-003)
    The investigational product, ACT-IOP-003, is an ACT implantable iontophoresis chemotherapy delivery device that delivers gemcitabine directly to the pancreas instead of through intravenous (IV) infusion into the blood stream.
Experimental
Cohort 2: ACT-IOP-003 Twice Weekly 		Gemcitabine treatment delivered via the ACT-IOP-003 study device twice weekly for 8 weeks
  • Combination Product: ACT Implantable Iontophoresis Chemotherapy Delivery Device with Gemcitabine (ACT-IOP-003)
    The investigational product, ACT-IOP-003, is an ACT implantable iontophoresis chemotherapy delivery device that delivers gemcitabine directly to the pancreas instead of through intravenous (IV) infusion into the blood stream.

Recruiting Locations

University of Michigan Health
Ann Arbor, Michigan 48109
Contact:
Study Coordinator

West Virginia University
Morgantown, West Virginia 26506
Contact:
Study Coordinator

More Details

Status
Recruiting
Sponsor
Continuity Biosciences, LLC

Study Contact

Nancy A Sacco, PhD
847-345-3931
nsacco@continuitybiosciences.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.