[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629954":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":25,"locations":35,"responsibleParty":65,"collaborators":24,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":24,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":24,"enrollmentInfo":76,"targetDuration":24,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":38,"whyStopped":24,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Continuity Biosciences, LLC","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1: ACT-IOP-003 Once Weekly","EXPERIMENTAL","Gemcitabine treatment delivered via the ACT-IOP-003 study device once weekly for 8 weeks",[13],"Combination Product: ACT Implantable Iontophoresis Chemotherapy Delivery Device with Gemcitabine (ACT-IOP-003)",{"label":15,"type":10,"description":16,"interventionNames":17},"Cohort 2: ACT-IOP-003 Twice Weekly","Gemcitabine treatment delivered via the ACT-IOP-003 study device twice weekly for 8 weeks",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"COMBINATION_PRODUCT","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.",[9,15],null,[26,31],{"name":27,"role":28,"phone":29,"phoneExt":24,"email":30},"Nancy A Sacco, PhD","CONTACT","847-345-3931","nsacco@continuitybiosciences.com",{"name":32,"role":28,"phone":33,"phoneExt":24,"email":34},"Allison Marquette","619-341-2232","allison@continuitybiosciences.com",[36,53],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"University of Michigan Health","RECRUITING","Ann Arbor","Michigan","48109","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-83.74088,42.27756,{"lat":48,"lon":47},[51],{"name":52,"role":28,"phone":24,"phoneExt":24,"email":24},"Study Coordinator",{"facility":54,"status":38,"city":55,"state":56,"zip":57,"country":42,"countryCode":43,"cosmosGeoPoint":58,"geoPoint":62,"contacts":63},"West Virginia University","Morgantown","West Virginia","26506",{"type":45,"coordinates":59},[60,61],-79.9559,39.62953,{"lat":61,"lon":60},[64],{"name":52,"role":28,"phone":24,"phoneExt":24,"email":24},{"type":66,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","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":77,"type":78},12,"ESTIMATED","INTERVENTIONAL",[81],"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.",[84],"Pancreatic Adenocarcinoma Non-resectable",[86,87,88],"Pancreatic Cancer","Non-resectable Tumor","Solid Tumor","2026-04-29",{"date":91,"type":92},"2026-05-01","ACTUAL",{"date":94,"type":92},"2026-03-11",{"date":96,"type":78},"2027-11-01",{"name":5,"class":6},2]