Pancreatic Adenocarcinoma Non-resectable
Conditions
Keywords
Pancreatic Cancer, Non-resectable Tumor, Solid Tumor
Brief 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.
Interventions
COMBINATION_PRODUCTACT 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.
Sponsors
Continuity Biosciences, LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
5 + 1 (modified 3 +3 design)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Pharmacokinetic (PK) Concentrations Assessed by Plasma PK of Gemcitabine Pre- and Post-dose | Screening through Week 8 | Plasma PK of gemcitabine pre- and post-dose as measured by Cmax |
Countries
United States
Contacts
CONTACTAllison Marquette
Outcome results
None listed