[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Continuity Biosciences, LLC\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":44},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100629954","phase-1-a-first-in-human-study-to-evaluate-implantable-iontophoresis-chemotherapy-delivery-device-with-gemcitabine-once-weekly-or-twice-weekly-in-participants-with-pancreatic-cancer-100629954",false,"NCT07481383","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, Phase 1b Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ACT Implantable Iontophoresis Chemotherapy Delivery Device With Gemcitabine (ACT-IOP-003) Once Weekly or Twice Weekly Following First-Line Systemic Chemotherapy in Participants With Nonresectable Pancreatic Cancer","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.\n* 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.\n* Initial diagnosis of borderline or locally advanced pancreatic adenocarcinoma confirmed as being nonresectable at the time of exploratory laparoscopic and\u002F or open surgery.\n* Previously received prior standard of care\u002Fneoadjuvant chemotherapy of FOLFIRINOX or GEM Abraxane for their current diagnosis of pancreatic cancer.\n\nExclusion Criteria:\n\n* Current pancreatitis classified as severe or critical.\n* Prior radiation treatment as part of standard of care\u002Fneoadjuvant treatment for pancreatic cancer.\n* Evidence of metastatic pancreatic cancer or any other type of cancer upon screening of through CT\u002FMRI.\n* Any medical history of past or present cardiovascular disease related to heart function.\n* Any metal implants.\n\nNote: Other inclusion\u002Fexclusion criteria apply.","ALL","18 Years",{"count":19,"type":20},12,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","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.\n\nThe main questions the study aims to answer are:\n\n* Is ACT-IOP-003 safe and tolerable when given to patients with nonmetastatic, locally advanced, nonresectable pancreatic cancer.\n* How much study drug (gemcitabine) is found in the blood before and after treatment.\n* If the tumor responds to treatment.\n* If the gemcitabine side effects are less than seen when delivered intravenously (IV).\n\nStudy participants will:\n\n* Have the study device surgically placed on the pancreas at the beginning of the study.\n* 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.\n* Give blood, urine, and stool samples to monitor safety and determine how much of the study drug (gemcitabine) is in the blood.\n* Have imaging (CT) done at least three times during the study.",[26],"Pancreatic Adenocarcinoma Non-resectable",[28,29,30],"Pancreatic Cancer","Non-resectable Tumor","Solid Tumor","RECRUITING","2026-04-29",{"date":34,"type":35},"2026-05-01","ACTUAL",{"date":37,"type":35},"2026-03-11",{"date":39,"type":20},"2027-11-01",{"name":41,"class":42},"Continuity Biosciences, LLC","INDUSTRY",2,""]