[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Ajax Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":46},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100542510","phase-1-a-phase-1-study-of-aj1-11095-in-patients-with-primary-myelofibrosis-pmf-post-polycythemia-vera-myelofibrosis-ppv-mf-or-post-essential-thrombocythemia-myelofibrosis-pet-mf-who-have-been-failed-by-a-type-i-jak2-inhibitor-jak2i-100542510",false,"NCT06343805","A Phase 1 Study of LY5830966 in Participants With Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (PPV-MF), or Post-Essential Thrombocythemia Myelofibrosis (PET-MF) Who Have Been Failed by a Type I JAK2 Inhibitor (JAK2i)","A Phase 1, Open-Label Study of LY5830966, a Type II JAK2 Inhibitor, in Patients With Myelofibrosis Previously Treated With a Type I JAK2 Inhibitor, JAK2 Inhibitor-Naïve Myelofibrosis, or High-risk Relapsed\u002FRefractory Polycythemia Vera","Inclusion Criteria:\n\n* Diagnosis of PMF, post-PV MF, or post-ET MF.\n* Dynamic International Prognostic Scoring System (DIPSS) Intermediate-1, Intermediate-2 or High-risk MF with less than or equal to (≤)10% blasts, regardless of JAK2 mutation status.\n* Estimated spleen volume greater than or equal to (≥)450 cubic centimeter (cm ³)\n* Myelofibrosis Symptom Assessment Form, version 4.0 (MFSAF v.4.0) TSS ≥10, or at least 2 of 7 MFSAF-assessed symptoms with scores ≥3.\n* Eastern Cooperative Oncology Group performance score (ECOG PS) of 0, 1, 2, or 3.\n* Prior therapy with at least 1 type I JAK2 inhibitor, and either failed to achieve a response or relapsed after achieving a response.\n* Absolute neutrophil count greater than or equal to 1,000 per microliter of blood (ANC ≥1.0×10\\^9\u002FL).\n* Platelet count ≥75×10\\^9\u002FL.\n* Estimated glomerular filtration rate greater than or equal to 45 milliliters per minute per 1.73 square meters (eGFR ≥45 mL\u002Fmin\u002F1.73m²).\n* Serum total bilirubin ≤2.0 × upper limit of normal (ULN).\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 × upper limit normal (ULN).\n* QTcF ≤470 msec.\n\nPolycythemia vera (PV) Only\n\n* Confirmed diagnosis of PV\n* Participants must have high-risk disease as defined by 60 years of age or older and\u002For have prior history of thrombotic event\n* R\u002FR or intolerant to at least one line of prior therapy including but not limited to interferon-based therapies, ruxolitinib, or hydroxyurea (HU) as defined by European LeukemiaNet (ELN) criteria\n\nExclusion Criteria:\n\n* Prior splenectomy or splenic irradiation within 3 months.\n* Ongoing use of systemic corticosteroids at dose equivalent to greater than (\\>) 20 milligrams per day (mg\u002Fday) of prednisone.\n* Active, uncontrolled systemic infection or active Hepatitis B or C\n* Chemotherapy in the previous 4 weeks or prior JAK2 inhibitor not discontinued per required washout prior to first dose\n* Peripheral neuropathy ≥ Grade 2 (NCI CTCAE v 5.0).\n* Pregnant or breastfeeding: males planning to father a child during treatment and for 3 months after last dose.\n* Requirement for therapy with a medication that is a strong Cytochrome P450 3A4 CYP3A4 inhibitor as a concomitant medication.\n* Currently on an interventional therapeutic trial in the treatment phase.\n* Significant cardiovascular disease\n* Active second primary malignancy (or diagnosed within 2 years) at high risk of progression, with standard exceptions (treated skin cancer, in situ cervical cancer, curatively treated localized breast\u002Fprostate cancer)\n* Prolongation of the corrected QTcF ≥470 millisecond during screening\n* Individual with a history of (noninfectious) pneumonitis\u002Finterstitial lung disease.\n\nFirst line (1L) MF only:\n\n* Prior treatment with JAK2 inhibitors\n\nHigh-risk R\u002FR PV only:\n\n* Prior PV-directed therapy without required washout\n* Active or chronic bleeding within 2 months prior to enrollment\n* Clinically significant thrombosis (e.g., pulmonary embolism, deep vein thrombosis, or splenic vein thrombosis) within 2 months prior to enrollment\n* Requires phlebotomy at hematocrit levels \\\u003C45%.","ALL","18 Years",{"count":19,"type":20},256,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","J8G-MC-JDIA (AJX-101) is a first-in-human (FIH), phase 1, non-randomized, multi-center, open-label clinical trial designed to investigate the safety, tolerability, pharmacokinetics (PK), clinical activity and changes in biomarkers of an orally administered type II Janus Kinase 2 (JAK2) inhibitor, LY5830966, in participants with primary or secondary myelofibrosis previously treated with at least one type I JAK2 inhibitor.",[26],"Primary Myelofibrosis",[28,29,30,31,32],"Post-Essential Thrombocythemia Myelofibrosis","Post-Polycythemia Vera Myelofibrosis","PMF","PPV-MF","PET-MF","RECRUITING","2026-10-06",{"date":36,"type":37},"2026-10-09","ACTUAL",{"date":39,"type":37},"2024-10-03",{"date":41,"type":20},"2028-12",{"name":43,"class":44},"Ajax Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company","INDUSTRY",21,""]