[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633858":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":32,"centralContacts":37,"locations":41,"responsibleParty":43,"collaborators":41,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":41,"eligibilityCriteria":51,"healthyVolunteers":47,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":41,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":41,"overallStatus":64,"whyStopped":41,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":41},{"fullName":5,"class":6},"Chong Kun Dang Pharmaceutical","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental group 1","EXPERIMENTAL","Period 1: Test drug(CKD-215) Period 2: Reference drug(D215)",[13,14],"Drug: CKD-215","Drug: D215",{"label":16,"type":10,"description":17,"interventionNames":18},"Experimental group 2","Period 1: Reference drug(D215) Period 2: Test drug(CKD-215)",[13,14],[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","CKD-215","2 tablets BID at 12-hour intervals for 7 days",[9,16],[26],"TEST drug",{"type":21,"name":28,"description":23,"armGroupLabels":29,"otherNames":30},"D215",[9,16],[31],"Reference drug",[33],{"name":34,"affiliation":35,"role":36},"Jeong-Yeol Park, Ph.D","Asan Medical Center","STUDY_CHAIR",[38],{"name":34,"role":39,"phone":40,"phoneExt":41,"email":42},"CONTACT","82-2-3010-3646",null,"catgut1-0@hanmail.net",{"type":44,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR","100633858","phase-1-study-of-ckd-215-and-d215-in-adults-with-brca-mutated-advanced-ovarian-fallopian-tube-or-primary-peritoneal-cancer-100633858",false,"NCT07532148","Study of CKD-215 and D215 in Adults With BRCA-mutated Advanced Ovarian, Fallopian Tube, or Primary Peritoneal Cancer","A Multicenter, Randomized, Open-Label, 2-Period Crossover Study to Evaluate Pharmacokinetics, Safety, and Tolerability of CKD-215 and D215 in Adults With Advanced BRCA-Mutated Ovarian, Fallopian Tube, or Primary Peritoneal Cancer","Inclusion Criteria:\n\n* Between 19 aged and 75 aged in patients with advanced BRCA-mutated high-grade epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer\n* 18.0kg\u002Fm2≤body mass index(BMI)≤28.0kg\u002Fm2\n\nExclusion Criteria:\n\n* Have a gastrointestinal disease(Crohn's disease, ulcer etc.) history that can effect drug absorption or surgery\n* Patients with central nervous system metastases, unless clinically stable after treatment\n* CTCAE Grade 3 or higher adverse events(e.g., anemia, neutropenia, dysgeusia, cough, leukopenia, thrombocytopenia) related to D215\n* Subjects who are unable to participate in this clinical trial at the discretion of the investigator","FEMALE","19 Years","75 Years",{"count":56,"type":57},24,"ESTIMATED","INTERVENTIONAL",[60],"PHASE1","Clinical Trial to evaluate the pharmacokinetic Characteristics, safety and Tolerability among CKD-215 and D215",[63],"Ovarian Cancer","NOT_YET_RECRUITING","2026-04-09",{"date":67,"type":68},"2026-04-15","ACTUAL",{"date":70,"type":57},"2026-06",{"date":72,"type":57},"2027-08",{"name":5,"class":6}]