BridgeMD
New treatment option for Pancreatic Adenocarcinoma Non-resectable
Official title A First-in-Human Study to Evaluate Implantable Iontophoresis Chemotherapy Delivery Device With Gemcitabine Once Weekly or Twice Weekly in Participants With Pancreatic Cancer
ClinicalTrials.gov ID: NCT07481383
What this study is testing
What is ACT Implantable Iontophoresis Chemotherapy Delivery Device with Gemcitabine (ACT-IOP-003)?
ACT Implantable Iontophoresis Chemotherapy Delivery Device with Gemcitabine (ACT-IOP-003) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for pancreatic adenocarcinoma non-resectable.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Initial diagnosis of borderline or locally advanced pancreatic adenocarcinoma confirmed as being nonresectable at the time of exploratory...
- Previously received prior standard of care/neoadjuvant chemotherapy of FOLFIRINOX or GEM Abraxane for their current diagnosis of pancreatic cancer.
You likely can't join if
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Ann Arbor, Michigan, United States
- Morgantown, West Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ann Arbor, Michigan, United States; Morgantown, West Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.