[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623921":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":27,"centralContacts":28,"locations":34,"responsibleParty":113,"collaborators":27,"id":115,"slug":116,"hasResults":117,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":27,"eligibilityCriteria":121,"healthyVolunteers":117,"sex":122,"minAge":123,"maxAge":27,"enrollmentInfo":124,"targetDuration":27,"studyType":127,"phases":128,"briefSummary":130,"conditions":131,"keywords":135,"overallStatus":62,"whyStopped":27,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":147},{"fullName":5,"class":6},"AstraZeneca","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"AZD5335\u002FAZD5335 + Itraconazole","EXPERIMENTAL","In Part A, participants will receive AZD5335 alone as an intravenous (IV) infusion, and in combination with oral itraconazole, every 3 weeks (Q3W) from cycle 1 to cycle 3. In Part B, participants will receive AZD5335 as an IV infusion Q3W, from Day 1 of Cycle 4 until progression, unacceptable toxicity or any other specified criteria for discontinuation occurs.",[13,14],"Drug: AZD5335","Drug: Itraconazole",[16,23],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","AZD5335","AZD5335 will be administered as IV infusion.",[9],[22],"AZ14170132",{"type":17,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"Itraconazole","Itraconazole capsule will be administered orally.",[9],null,[29],{"name":30,"role":31,"phone":32,"phoneExt":27,"email":33},"AstraZeneca Clinical Study Information Center","CONTACT","1-877-240-9479","information.center@astrazeneca.com",[35,48,56,61,72,82,92,100,108],{"facility":36,"status":37,"city":38,"state":27,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":27},"Research Site","NOT_YET_RECRUITING","Batumi","6010","Georgia","GE",{"type":43,"coordinates":44},"Point",[45,46],41.6306,41.64077,{"lat":46,"lon":45},{"facility":36,"status":37,"city":49,"state":27,"zip":50,"country":40,"countryCode":41,"cosmosGeoPoint":51,"geoPoint":55,"contacts":27},"Tbilisi","0114",{"type":43,"coordinates":52},[53,54],44.83412,41.69143,{"lat":54,"lon":53},{"facility":36,"status":37,"city":49,"state":27,"zip":57,"country":40,"countryCode":41,"cosmosGeoPoint":58,"geoPoint":60,"contacts":27},"112",{"type":43,"coordinates":59},[53,54],{"lat":54,"lon":53},{"facility":36,"status":62,"city":63,"state":27,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":71,"contacts":27},"RECRUITING","Dublin","D07 R2WY","Ireland","IE",{"type":43,"coordinates":68},[69,70],-6.24889,53.33306,{"lat":70,"lon":69},{"facility":36,"status":62,"city":73,"state":27,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":81,"contacts":27},"Lisbon","1250-068","Portugal","PT",{"type":43,"coordinates":78},[79,80],-9.1498,38.72509,{"lat":80,"lon":79},{"facility":36,"status":62,"city":83,"state":27,"zip":84,"country":85,"countryCode":86,"cosmosGeoPoint":87,"geoPoint":91,"contacts":27},"Barcelona","08023","Spain","ES",{"type":43,"coordinates":88},[89,90],2.15899,41.38879,{"lat":90,"lon":89},{"facility":36,"status":62,"city":93,"state":27,"zip":94,"country":85,"countryCode":86,"cosmosGeoPoint":95,"geoPoint":99,"contacts":27},"Logroño","26006",{"type":43,"coordinates":96},[97,98],-2.45115,42.46615,{"lat":98,"lon":97},{"facility":36,"status":62,"city":101,"state":27,"zip":102,"country":85,"countryCode":86,"cosmosGeoPoint":103,"geoPoint":107,"contacts":27},"Madrid","28040",{"type":43,"coordinates":104},[105,106],-3.70256,40.4165,{"lat":106,"lon":105},{"facility":36,"status":62,"city":101,"state":27,"zip":109,"country":85,"countryCode":86,"cosmosGeoPoint":110,"geoPoint":112,"contacts":27},"28050",{"type":43,"coordinates":111},[105,106],{"lat":106,"lon":105},{"type":114,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100623921","phase-1-drug-drug-interaction-study-with-azd5335-and-itraconazole-in-participants-with-ovarian-primary-peritoneal-or-fallopian-tube-cancer-100623921",false,"NCT07402915","Drug-drug Interaction Study With AZD5335 and Itraconazole in Participants With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer","An Open-label, Fixed Sequence Phase I Study to Evaluate the Effect of Itraconazole (a Strong CYP3A Inhibitor) on the Pharmacokinetics of AZ14170132, the TOP1 Inhibitor Payload of the Antibody Drug Conjugate AZD5335, in Participants With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer","Inclusion Criteria:\n\n* Participants with Platinum-resistant, relapsed, high- grade epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer and: (a) have received at least 1 prior line of platinum-containing chemotherapy and have progressed on or within 6 months after the date of the last dose of platinum; (b) must have received prior bevacizumab and\u002For Poly (ADP-ribose) polymerase (PARP) inhibitors according to local guidelines, unless ineligible.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n\nExclusion Criteria:\n\n* Spinal cord compression or a history of leptomeningeal carcinomatosis.\n* Unresolved toxicities of Grade ≥ 2 (National Cancer Institute-Common Terminology Criteria for Adverse Events v5.0) from prior therapy.\n* History of (non-infectious) interstitial lung disease (ILD)\u002Fpneumonitis that required oral or IV steroids or supplemental oxygen, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n* Uncontrolled intercurrent illness within 12 months prior to screening.\n* Any other contraindication for receiving itraconazole according to the prescribing information and the Investigator.","FEMALE","18 Years",{"count":125,"type":126},24,"ESTIMATED","INTERVENTIONAL",[129],"PHASE1","The purpose of this study is to assess the effect of itraconazole on the pharmacokinetics (PK) of AZ14170132.",[132,133,134],"Fallopian Tube Cancer","Ovarian Cancer","Primary Peritoneal",[136,137],"CYP3A inhibitor","TOP1 inhibitor payload","2026-05-19",{"date":140,"type":141},"2026-05-20","ACTUAL",{"date":143,"type":141},"2026-01-26",{"date":145,"type":126},"2027-10-15",{"name":5,"class":6},9]