[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"essential-thrombocytosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:essential-thrombocytosis":31},{"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":32,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":5},"100532885","phase-1-pacritinib-w-talazoparib-in-pts-w-myeloproliferative-neoplasms-unresponsive-to-jak2-inhibition-100532885",false,"NCT06218628","Pacritinib w\u002F Talazoparib in Pts w\u002F Myeloproliferative Neoplasms Unresponsive to JAK2 Inhibition","Phase I Study Accessing the Safety of Pacritinib in Combination With Talazoparib in Patients With Myeloproliferative Neoplasms Unresponsive to Frontline JAK2 (Janus Kinase 2) Inhibition","Inclusion Criteria:\n\n* Patients must have histologically or cytologically confirmed primary myelofibrosis (PMF), post-polycythemia vera-myelofibrosis (PPV-MF), post-essential thrombocythemia-myelofibrosis (PET-MF), chronic myelomonocytic leukemia, polycythemia vera, or essential thrombocytosis according to the 2008 World Health Organization criteria\n* Subject has at least 2 symptoms with a score ≥ 3 or a total score of ≥ 12, as measured by the MFSAF(Myelofibrosis Symptom Assessment Form) v4.0\n* Subject classified as intermediate-2 or high-risk MF, as defined by the Dynamic International Prognostic Scoring System Plus (DIPSS+70).\n* Age \\> 18 years.\n* ECOG (Eastern Cooperative Oncology Group) performance status 0-2\n* Subject must have received prior treatment with a single JAK2 inhibitor 4.1.6 for at least 12 weeks with documented disease progression OR subject must have appearance of new splenomegaly that is palpable to at least 5 cm below the left costal margin (LCM) in subjects with no evidence of splenomegaly prior to the initiation of any first line JAK2 inhibitor\n* Baseline QTc (corrected QT interval) \\\u003C0.47 seconds (Bazett formula)\n* Patients must have normal organ function as defined in protocol.\n* Ability to understand and willingness to sign a written informed consent and HIPAA consent document\n\nExclusion Criteria:\n\n* Patients may not be receiving any other investigational agents\n* Subjects must not be experiencing toxicity due to prior therapy that has not resolved to ≤Grade 1 by study registration, with the exception of sensory neuropathy related to previous systemic therapy exposure, alopecia and fatigue.\n* Patients that have transformed to Acute Myeloid Leukemia defined by \\>20% blasts count on peripheral blood smear or bone marrow biopsy evaluation\n* Uncontrolled inter-current illness including, but not limited to, any other malignancy (with the exception of hormonal therapy for breast cancer\u002Fprostate cancer in remission \\>1 year and for non-hormonal therapies for other cancers in remission for \\>3 years), other ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Patients with history of hemorrhagic stroke and evidence of uncontrolled bleeding as well as bleeding disorder\n* Known HIV positive patients on combination antiretroviral therapy are ineligible because these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy.\n* Pregnant or breast-feeding.","ALL","18 Years",{"count":19,"type":20},24,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a prospective phase I dose-escalation study, with the primary objective to access the MTD and find the RP2D of talazoparib, given in combination with standard of care dosing of pacritinib.",[26,27,28,29,30,31],"Primary Myelofibrosis","Post-polycythemia Vera Myelofibrosis","Post-essential Thrombocythemia Myelofibrosis","Chronic Myelomonocytic Leukemia","Polycythemia Vera","Essential Thrombocytosis",[33,34,35,36],"Talazoparib","Pacritinib","JAK2 Inhibition","Myeloproliferative Neoplasm","RECRUITING","2024-05-02",{"date":40,"type":41},"2024-05-03","ACTUAL",{"date":43,"type":41},"2024-04-05",{"date":45,"type":20},"2030-08-27",{"name":47,"class":48},"Fox Chase Cancer Center","OTHER"]