Clareo Health | A First-in-Human Study to Evaluate Implantable Iontophoresis Chemotherapy Delivery Device With Gemcitabine Once Weekly or Twice Weekly in Participants With Pancreatic Cancer
A First-in-Human Study to Evaluate Implantable Iontophoresis Chemotherapy Delivery Device With Gemcitabine Once Weekly or Twice Weekly in Participants With Pancreatic Cancer
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.
You may not be 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.
