[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657141":3},{"organization":4,"outcomesModule":7,"designInfo":50,"detailedDescription":38,"studyPopulation":38,"armGroups":56,"interventions":62,"overallOfficials":67,"centralContacts":71,"locations":80,"responsibleParty":94,"collaborators":38,"id":96,"slug":97,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":38,"eligibilityCriteria":102,"healthyVolunteers":98,"sex":103,"minAge":104,"maxAge":38,"enrollmentInfo":105,"targetDuration":38,"studyType":108,"phases":109,"briefSummary":111,"conditions":112,"keywords":38,"overallStatus":114,"whyStopped":38,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Ono Pharmaceutical Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":38},[9],{"measure":10,"description":11,"timeFrame":12},"ORR at Week 24","Proportion of participants with a response of CR or PR based on independent radiological review, per RECIST v1.1","at Week 24",[14,18,21,24,27,30,33,36,39,41,43,45,48],{"measure":15,"description":16,"timeFrame":17},"Adverse events","To assess the safety of DCC-3014 in Japanese patients with TGCT","through study completion, an average of 3 year",{"measure":19,"description":20,"timeFrame":12},"ORR per TVS (Tumor Volume Score) at Week 24","Tumor response will be assessed by an independent radiological reviewer per TVS.",{"measure":22,"description":23,"timeFrame":12},"Change from Baseline in Range of Motion (ROM) at Week 24","Active and passive ROM of the affected and non-affected joints will be assessed",{"measure":25,"description":26,"timeFrame":12},"Change from baseline in PROMIS Physical Function score at Week 24","PROMIS(Patient-reported Outcomes Measurement Information System) Physical Function Score",{"measure":28,"description":29,"timeFrame":12},"Change from baseline in the Worst Stiffness NRS score at Week 24","NRS（Numeric rating scale） ranges from 0 to10, 0 is equivalent to no Stiffness and 10 indicates the worst possible Stiffness.",{"measure":31,"description":32,"timeFrame":12},"Change from baseline in EQ-VAS (self-rated health scale) at Week 24","The EQ-VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. EQ-VAS ranges from 0 to 100. Higher scores indicate better perceived health.",{"measure":34,"description":35,"timeFrame":12},"Proportion of participants with at least 30% improvement in mean BPI Worst Pain NRS score, without a 30% or greater increase in narcotic analgesic use at Week 24","BPI(Brief Pain Inventory) Worst Pain NRS ranges from 0 to10, 0 is equivalent to no pain and 10 indicates the worst possible pain.",{"measure":37,"description":38,"timeFrame":17},"Best of response per RECIST v1.1",null,{"measure":40,"description":38,"timeFrame":17},"Best of response per TVS",{"measure":42,"description":38,"timeFrame":17},"Duration of response per RECIST v1.1",{"measure":44,"description":38,"timeFrame":17},"Duration of response per TVS",{"measure":46,"description":38,"timeFrame":47},"Plasma DCC-3014 concentration","from Week 0 to Week 24",{"measure":49,"description":38,"timeFrame":47},"Plasma DP-7005 concentration",{"allocation":51,"interventionModel":52,"interventionModelDescription":38,"primaryPurpose":53,"observationalModel":38,"timePerspective":38,"maskingInfo":54},"NA","SINGLE_GROUP","TREATMENT",{"masking":55,"maskingDescription":38,"whoMasked":38},"NONE",[57],{"label":58,"type":59,"description":38,"interventionNames":60},"DCC-3014","EXPERIMENTAL",[61],"Drug: DCC-3014",[63],{"type":64,"name":58,"description":65,"armGroupLabels":66,"otherNames":38},"DRUG","DCC-3014 will be orally administered at a dose of 30 mg twice weekly.",[58],[68],{"name":69,"affiliation":5,"role":70},"Project Leader","STUDY_DIRECTOR",[72,77],{"name":73,"role":74,"phone":75,"phoneExt":38,"email":76},"North America Clinical Trial Support Desk","CONTACT","+18665877745 (Toll-Free)","clinical_trial@ono-pharma.com",{"name":78,"role":74,"phone":79,"phoneExt":38,"email":76},"International Clinical Trial Support Desk","+17162141777 (Standard)",[81],{"facility":82,"status":38,"city":83,"state":84,"zip":85,"country":86,"countryCode":87,"cosmosGeoPoint":88,"geoPoint":93,"contacts":38},"Cancer Institute Hospital of JFCR","Tokyo","Koto","135-8550","Japan","JP",{"type":89,"coordinates":90},"Point",[91,92],139.69171,35.6895,{"lat":92,"lon":91},{"type":95,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR","100657141","phase-2-a-study-of-dcc-3014-to-evaluate-the-efficacy-safety-and-pharmacokinetics-in-subjects-with-tgct-100657141",false,"NCT07832747","A Study of DCC-3014 to Evaluate the Efficacy, Safety, and Pharmacokinetics in Subjects With TGCT","A Phase 2, Multicenter, Open-label, Non-controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of DCC-3014 in Japanese Subjects With Tenosynovial Giant Cell Tumor (TGCT)","Inclusion Criteria:\n\n* Histologically confirmed diagnosis of TGCT (tumor biopsy to confirm diagnosis will be required if no histology\u002Fpathology is available at screening), and a TGCT in a single joint that can be assessed for range of motion (ROM)\n* TGCT for which surgical resection will potentially cause worsening functional limitation or severe morbidity\n* Participants who have symptoms defined as at least moderate pain or at least moderate stiffness during the screening period\n* Other protocol defined inclusion criteria may apply\n\nExclusion Criteria:\n\n* Metastatic TGCT or other active malignancy that requires treatment, or history of malignancy within 5 years prior to initiation of the screening period (excluding non-metastatic squamous cell carcinoma, basal cell carcinoma, or cervix carcinoma in situ with documented cure)\n* QT interval corrected by Fridericia's formula (QTcF) \\>450 ms in males or \\>470 ms in females, or history of long QT syndrome\n* Active liver or biliary disease, including nonalcoholic steatohepatitis (NASH) or cirrhosis\n* Other protocol defined exclusion criteria may apply","ALL","18 Years",{"count":106,"type":107},18,"ESTIMATED","INTERVENTIONAL",[110],"PHASE2","To evaluate the efficacy, safety, and pharmacokinetics of DCC-3014 in subjects with Tenosynovial Giant Cell Tumor",[113],"Tenosynovial Giant Cell Tumor","NOT_YET_RECRUITING","2026-09-15",{"date":117,"type":118},"2026-09-22","ACTUAL",{"date":120,"type":107},"2026-10-31",{"date":122,"type":107},"2030-05-31",{"name":5,"class":6},1]