[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Ajax Therapeutics, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":45},{"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":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"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 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)","A Multicenter, Open-Label, Phase 1 Study of AJ1-11095 Administered as Oral Monotherapy 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)","Inclusion Criteria:\n\n1. 18 years of age or older.\n2. Diagnosis of PMF, post-PV MF, or post-ET MF.\n3. DIPSS Intermediate-2 or High-risk MF with ≤10% blasts, regardless of JAK2 mutation status.\n4. Estimated spleen volume ≥450cm3.\n5. MFSAF v.4.0 TSS ≥10, or at least 2 of 7 MFSAF-assessed symptoms with scores ≥3.\n6. ECOG PS of 0, 1, 2, or 3.\n7. Prior therapy with at least 1 type I JAK2 inhibitor, and either failed to achieve a response or relapsed after achieving a response.\n8. ANC ≥1.0×10\\^9\u002FL.\n9. Platelet count ≥75×10\\^9\u002FL.\n10. eGFR ≥45 mL\u002Fmin\u002F1.73m2.\n11. Serum total bilirubin ≤2.0 × upper limit of normal (ULN).\n12. AST and ALT ≤3.0 × ULN.\n13. QTcF ≤480 msec.\n\nExclusion Criteria:\n\n1. Prior splenectomy.\n2. Splenic irradiation within 3 months prior to first dose of study drug.\n3. Ongoing use of systemic corticosteroids at dose equivalent to \\>10mg\u002Fday of prednisone.\n4. Uncontrolled intercurrent illness such as an acute infection.\n5. Chronic active or acute hepatitis B or C infection.\n6. Chemotherapy in the previous 4 weeks prior to first dose of study drug (Hydrea is permitted until 5 days before starting protocol therapy).\n7. Use of a Type I JAK2 inhibitor must have been discontinued for at least 5 days or 5 half-lives prior to dosing (whichever is longer).\n8. Use of erythropoiesis stimulating agents (unless stable for \\>8 weeks).\n9. Peripheral neuropathy ≥ Grade 2 (NCI CTCAE v 5.0).\n10. Unable or unwilling to undergo CT or MRI for spleen size imaging.\n11. Pregnant or breastfeeding.\n12. Requirement for therapy with a medication that is a strong CYP3A4 inhibitor as a concomitant medication.","ALL","18 Years",{"count":19,"type":20},76,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","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 JAK2 inhibitor, AJ1-11095, in subjects with primary or secondary myelofibrosis previously treated with at least one type I JAK2 inhibitor.",[26,27,28,29,30,31],"Primary Myelofibrosis","Post-Essential Thrombocythemia Myelofibrosis","Post-Polycythemia Vera Myelofibrosis","PMF","PPV-MF","PET-MF","RECRUITING","2026-05-08",{"date":35,"type":36},"2026-05-12","ACTUAL",{"date":38,"type":36},"2024-10-23",{"date":40,"type":20},"2027-02-15",{"name":42,"class":43},"Ajax Therapeutics, Inc.","INDUSTRY",21,""]