[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100500315":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":53,"centralContacts":58,"locations":66,"responsibleParty":83,"collaborators":62,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":87,"sex":93,"minAge":94,"maxAge":62,"enrollmentInfo":95,"targetDuration":62,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":109,"whyStopped":62,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Aston Sci. Inc.","INDUSTRY",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"AST-301","EXPERIMENTAL","AST-201 with rhuGM-CSF (3-week interval, 3 cycles in total)\n\nStandard chemotherapy (paclitaxel\u002Fcarboplatin) (3-week interval, 6 cycles in total)\n\n\\* Both AST-201\u002FrhuGM-CSF or Placebo\u002FrhuGM-CSF will be given intradermally 2 weeks after each combination chemotherapy (on Day 15 of each cycle) for 3 cycles",[13,14,15,16],"Biological: AST-201","Drug: Paclitaxel","Drug: Carboplatin","Drug: rhuGM-CSF(Granulocyte-Macrophage Colony-Stimulating Factor)",{"label":18,"type":19,"description":20,"interventionNames":21},"Placebo","PLACEBO_COMPARATOR","Placebo with rhuGM-CSF (3-week interval, 3 cycles in total)\n\nStandard chemotherapy (paclitaxel\u002Fcarboplatin) (3-week interval, 6 cycles in total)\n\n\\*Both AST-201\u002FrhuGM-CSF or Placebo\u002FrhuGM-CSF will be given intradermally 2 weeks after each combination chemotherapy (on Day 15 of each cycle) for 3 cycles",[14,15,22,16],"Drug: Placebo",[24,31,38,43,47],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"BIOLOGICAL","AST-201","i.d. (3-week interval, 3 cycles in total)",[9],[30],"pUMVC3-hIGFBP-2 multi-epitope plasmid DNA vaccine",{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","Paclitaxel","3-week interval, 6 cycles in total",[9,18],[37],"Taxol",{"type":32,"name":39,"description":34,"armGroupLabels":40,"otherNames":41},"Carboplatin",[9,18],[42],"Paraplatin",{"type":32,"name":18,"description":27,"armGroupLabels":44,"otherNames":45},[18],[46],"Normal saline (USP)",{"type":32,"name":48,"description":27,"armGroupLabels":49,"otherNames":50},"rhuGM-CSF(Granulocyte-Macrophage Colony-Stimulating Factor)",[9,18],[51,52],"sargramostim","Leukine",[54],{"name":55,"affiliation":56,"role":57},"Hyunwon Shin, MD, PhD","hyunwon.shin@astonsci.com","STUDY_DIRECTOR",[59,63],{"name":55,"role":60,"phone":61,"phoneExt":62,"email":56},"CONTACT","+82-2-2038-2347",null,{"name":64,"role":60,"phone":61,"phoneExt":62,"email":65},"Eunkyo Joung, MD, CMO","eunkyo.joung@astonsci.com",[67],{"facility":68,"status":62,"city":69,"state":70,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"University of Washington","Seattle","Washington","98109","United States","US",{"type":75,"coordinates":76},"Point",[77,78],-122.33207,47.60621,{"lat":78,"lon":77},[81],{"name":82,"role":60,"phone":62,"phoneExt":62,"email":62},"John B. Liao, MD, PhD",{"type":84,"investigatorFullName":62,"investigatorTitle":62,"investigatorAffiliation":62,"oldNameTitle":62,"oldOrganization":62},"SPONSOR","100500315","phase-2-adjuvant-therapeutic-cancer-vaccine-ast-201-pumvc3-higfbp-2-in-patients-with-advanced-ovarian-cancer-100500315",false,"NCT05794659","Adjuvant Therapeutic Cancer Vaccine (AST-201, pUMVC3-hIGFBP-2) in Patients With Advanced Ovarian Cancer","A Randomized Phase 2 Study to Evaluate the Efficacy and Safety for Adjuvant Therapeutic Cancer Vaccine (AST-201, pUMVC3-hIGFBP-2) in Patients With Advanced Ovarian Cancer (Cornerstone-004)","Cornerstone4","Inclusion Criteria:\n\n* Newly diagnosed stage III (FIGO classification) epithelial ovarian cancer including primary peritoneal cancer, fallopian-tube cancer\n* Has received upfront surgery and optimally debulked(a residual tumor less than 1 cm)\n* Can start adjuvant therapy within 6 weeks of debulking surgery\n* Has Homologous Recombination Proficiency (HRP) tumor defined by FDA-approved testing\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Demonstrates adequate organ function.\n\nExclusion Criteria:\n\n* Has a history of hypersensitivity or other contraindications to rhuGM-CSF\n* Has a history of active malignancy ≤5 years prior to first administration of investigational drug except for adequately treated non-melanoma skin cancer or epithelial carcinoma without evidence of disease\n* Is on immune suppression therapy or has a history of immune suppression therapy ≤4 weeks prior to the first administration of investigational drugs\n* Has active or prior autoimmune disease or inflammatory disease\n* Has active infectious disease including tuberculosis, hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection\n* Is pregnant or breastfeeding or expecting to conceive children within the projected duration of the study","ALL","18 Years",{"count":96,"type":97},98,"ESTIMATED","INTERVENTIONAL",[100],"PHASE2","The purpose of this phase 2 study is to assess the efficacy and safety for adjuvant therapeutic cancer vaccine AST-201 (pUMVC3-hIGFBP-2) in patients with newly diagnosed homologous-recombination proficient(HRP) advanced ovarian cancer (Stage III) after debulking surgery. Patients will receive AST-201 with rhuGM-CSF(Colony Stimulating Factor) or placebo with rhuGM-CSF in combination with standard adjuvant chemotherapy(Paclitaxel\u002FCarboplatin).",[103],"Advanced Ovarian Cancer",[105,106,107,108],"cancer vaccine","phase 2 study","Advanced ovarian cancer","homologous-recombination proficient (HRP)","NOT_YET_RECRUITING","2023-07-18",{"date":112,"type":113},"2023-07-20","ACTUAL",{"date":115,"type":97},"2023-11-15",{"date":117,"type":97},"2027-11-15",{"name":5,"class":6},1]