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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Safety, Tolerability, and Maximum Tolerated Delivered Dose as Assessed by Adverse Event Reporting — Screening through Week 20
  Incidence of adverse events (AEs), serious adverse events (SAEs), drug- or device-related AEs, and dose-limiting toxicities (DLTs)
• Safety, Tolerability, and Maximum Tolerated Delivered Dose as Assessed by Adverse Event Reporting — Screening through Week 20
  Incidence of clinically significant abnormalities in physical examinations
• Safety, Tolerability, and Maximum Tolerated Delivered Dose as Assessed by Adverse Event Reporting — Screening through Week 20
  Incidence of clinically significant abnormalities in vital signs
• Safety, Tolerability, and Maximum Tolerated Delivered Dose as Assessed by Adverse Event Reporting — Screening through Week 20
  Incidence of clinically significant abnormalities in clinical laboratory tests (clinical chemistry, hematology, urinalysis)
• Safety, Tolerability, and Maximum Tolerated Delivered Dose as Assessed by Adverse Event Reporting — Screening through Week 20
  Incidence of clinically significant abnormalities in 12-lead electrocardiograms (ECGs)

Trial sites (2)