[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Kartos Therapeutics, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":102},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,52,78],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100552903","phase-3-study-of-navtemadlin-add-on-to-ruxolitinib-in-jak-inhibitor-nave-patients-with-myelofibrosis-who-have-a-suboptimal-response-to-ruxolitinib-100552903",false,"NCT06479135","Study of Navtemadlin add-on to Ruxolitinib in JAK Inhibitor-Naïve Patients With Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib","A Phase 3, Randomized, Double-blind, Add-on Study Evaluating the Safety and Efficacy of Navtemadlin Plus Ruxolitinib vs Placebo Plus Ruxolitinib in JAK Inhibitor-Naïve Patients With Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib","POIESIS","Inclusion Criteria for Ruxolitinib Alone Period:\n\n* Confirmed diagnosis of PMF, post-PV MF, or post-ET MF, as assessed by the treating physician according to the World Health Organization (WHO) criteria\n* High, Intermediate-1, Intermediate-2 risk category International Prognosis System Score (IPSS)\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2\n* JAK-inhibitor treatment naive\n\nExclusion Criteria for Ruxolitinib Alone Period:\n\n* Prior Splenectomy\n* Splenic irradiation within 3 months prior to the first dose\n* Prior BCL-XL, BET, MDM2, PI3K, PIM, or XPO1 inhibitors therapy or p53-directed therapy\n* Eligible for Bone Marrow Transplant\n* Peripheral blood or bone marrow blast count ≥ 10 percent\n\nInclusion Criteria for Randomized Period:\n\n* PMF, post-PV MF, or post-ET MF that is TP53WT as assessed by central testing\n* ECOG performance status of 0 to 2\n* Treatment with a stable dose of ruxolitinib\n* Suboptimal response to run-in ruxolitinib treatment\n\nExclusion Criteria for Randomized Period:\n\n* Elevated white blood cell count that doubles (or more) during ruxolitinib treatment and exceeds 50 × 10\\^9\u002FL\n* Peripheral blood or bone marrow blast count ≥ 10 percent","ALL","18 Years",{"count":20,"type":21},600,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This clinical trial is evaluating whether addition of navtemadlin to ruxolitinib treatment will provide more clinical benefit than ruxolitinib alone for patients with Myelofibrosis who have a suboptimal response to ruxolitinib treatment alone.\n\nSubjects will start by receiving ruxolitinib alone in the run-in period. Those who demostrate a suboptimal response from ruxolitinib alone will then be randomized 2:1 to receive navtemadlin or navtemadlin placebo as add-on treatment to their ongoing ruxolitinib. Randomized means that subjects will be assigned to a group by chance, like a flip of a coin. The study is blinded, meaning the subjects, doctors, central endpoint assessors and sponsor will not know which add on treatment (navtemadlin or navtemadlin placebo) the subject is receiving.",[27,28,29,30,31],"Myelofibrosis","Post-PV MF","Post-ET Myelofibrosis","Primary Myelofibrosis","MF",[33,34,35,15,36,37,38],"Navtemadlin","KRT-232","Ruxolitinib","TP53","Suboptimal response","Sub-optimal response","RECRUITING","2025-09-22",{"date":42,"type":43},"2025-09-25","ACTUAL",{"date":45,"type":43},"2024-06-03",{"date":47,"type":21},"2028-12-31",{"name":49,"class":50},"Kartos Therapeutics, Inc.","INDUSTRY",215,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":59,"minAge":18,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":22,"phases":62,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},"100500559","phase-2-study-of-navtemadlin-as-maintenance-therapy-in-tp53wt-advanced-or-recurrent-endometrial-cancer-100500559","NCT05797831","Study of Navtemadlin as Maintenance Therapy in TP53WT Advanced or Recurrent Endometrial Cancer","A Phase 2\u002F3 Study of Navtemadlin as Maintenance Therapy in Subjects With TP53WT Advanced or Recurrent Endometrial Cancer Who Responded to Chemotherapy","Inclusion Criteria:\n\n* ECOG 0-1\n* Histologically or cytologically confirmed diagnosis of endometrial cancer documented as TP53WT\n* Subjects with advanced or recurrent disease must have completed a single line of up to 6 cycles of taxane-platinum based chemo and achieved a CR or PR per RECIST V1.1\n* Adequate hematologic, hepatic and renal function (within 14 days)\n\nExclusion Criteria:\n\n* Has any sarcomas or small-cell carcinomas with neuroendocrine differentiation\n* Prior immune therapy, cytokine therapy, or any investigational therapy (within 28 days)\n* Indwelling surgical drains\n* Grade 2 or higher QTc prolongation\n* History of major organ transplant\n* History of bleeding diathesis; major hemorrhage or intracranial hemorrhage (within 24 weeks)","FEMALE",{"count":61,"type":21},268,[63,24],"PHASE2","This study evaluates navtemadlin as maintenance treatment for patients with advanced or recurrent endometrial cancer (EC) who have achieved complete response or partial response on chemotherapy.\n\nThe study will be conducted in 2 parts. Part 1 will evaluate safety and efficacy of two different doses of navtemadlin alongside an observational control arm to determine the Phase 3 navtemadlin dose. Part 2 will evaluate the efficacy and safety of navtemadlin Phase 3 dose compared to placebo.",[66],"Endometrial Cancer",[68],"navtemadlin","2024-04-30",{"date":71,"type":43},"2024-05-02",{"date":73,"type":43},"2023-07-17",{"date":75,"type":21},"2027-07",{"name":49,"class":50},83,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":22,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},"100426636","phase-1-krt-232-and-tki-study-in-chronic-myeloid-leukemia-100426636","NCT04835584","KRT-232 and TKI Study in Chronic Myeloid Leukemia","An Open-Label, Multicenter, Phase 1b\u002F2 Study of the Safety and Efficacy of KRT-232 Combined With a Tyrosine Kinase Inhibitor (TKI) in Patients With Relapsed or Refractory Ph+ Chronic Myeloid Leukemia (CML)","Inclusion Criteria:\n\n* Phase 1b and Phase 2 Arms A and B: Documented TP53wt, Ph+, BCR-ABL+ CML-CP\n* Phase 2 Arm C ONLY: Documented TP53wt, Ph+, BCR-ABL+ CML-AP\n* Subject is resistant (relapsed or refractory) and\u002For intolerant to at least 1 prior TKI.\n* Adults ≥ 18 years of age.\n* ECOG performance status of 0 to 2\n* Adequate hematologic, hepatic, and renal functions\n\nExclusion Criteria:\n\n* Phase 1b and Phase 2 Arms A and B: Documented Ph+, BCR-ABL+ CML-AP\n* Documented Ph+, BCR-ABL+ CML-BC\n* Known T315I mutation.\n* Prior treatment with MDM2 antagonist therapies.\n* Intolerance to current TKI therapy.",{"count":86,"type":21},109,[88,63],"PHASE1","This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with Ph+ Chronic Myeloid Leukemia (CML) who have relapsed or are refractory or intolerant to a Tyrosine Kinase Inhibitor (TKI).\n\nThis study is a global, open label Phase 1b\u002F2 to determine the efficacy and safety of KRT-232 in patients with chronic phase CML (CML-CP) and accelerated phase (CML-AP) who have failed TKI treatments.",[91],"Chronic Myeloid Leukemia",[68],"2022-03-04",{"date":95,"type":43},"2022-03-21",{"date":97,"type":43},"2021-05-07",{"date":99,"type":21},"2026-06-30",{"name":49,"class":50},26,""]