[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100532885":3},{"organization":4,"armGroups":7,"interventions":31,"overallOfficials":44,"centralContacts":48,"locations":55,"responsibleParty":72,"collaborators":53,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":53,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":53,"enrollmentInfo":83,"targetDuration":53,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":97,"overallStatus":58,"whyStopped":53,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Fox Chase Cancer Center","OTHER",[8,15,19,23,27],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose Level -1","EXPERIMENTAL","0.25 mg (PO, QD) Talazoparib (Days 1-7) 200 mg (PO, BID) Pacritinib (Day 1-28, Lead in dosing of Pacritinib day -7 for the first cycle of treatment)",[13,14],"Drug: Talazoparib","Drug: pacritinib",{"label":16,"type":10,"description":17,"interventionNames":18},"Dose Level 1","0.25 mg (PO, QD) Talazoparib (Days 1-14) 200 mg (PO, BID) Pacritinib (Day 1-28, Lead in dosing of Pacritinib day -7 for the first cycle of treatment)",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"Dose Level 2","0.5 mg (PO, QD) Talazoparib (Days 1-14) 200 mg (PO, BID) Pacritinib (Day 1-28, Lead in dosing of Pacritinib day -7 for the first cycle of treatment)",[13,14],{"label":24,"type":10,"description":25,"interventionNames":26},"Dose Level 3","0.75 mg (PO, QD) Talazoparib (Days 1-14) 200 mg (PO, BID) Pacritinib (Day 1-28, Lead in dosing of Pacritinib day -7 for the first cycle of treatment)",[13,14],{"label":28,"type":10,"description":29,"interventionNames":30},"Dose Level 4","1 mg (PO, QD) Talazoparib (Days 1-14) 200 mg (PO, BID) Pacritinib (Day 1-28, Lead in dosing of Pacritinib day -7 for the first cycle of treatment)",[13,14],[32,39],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"DRUG","Talazoparib","pacritinib in combination with talazoparib",[9,16,20,24,28],[38],"talzenna",{"type":33,"name":40,"description":35,"armGroupLabels":41,"otherNames":42},"pacritinib",[9,16,20,24,28],[43],"vonjo",[45],{"name":46,"affiliation":5,"role":47},"Peter Abdelmessieh, DO, MSc","PRINCIPAL_INVESTIGATOR",[49],{"name":50,"role":51,"phone":52,"phoneExt":53,"email":54},"Abigail Protocol Development Coordinator","CONTACT","215-728-2451",null,"abigail.okeefe@fccc.edu",[56],{"facility":57,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"Fox Chase Cancer Center - Philadelphia","RECRUITING","Philadelphia","Pennsylvania","19111-2497","United States","US",{"type":65,"coordinates":66},"Point",[67,68],-75.16362,39.95238,{"lat":68,"lon":67},[71],{"name":50,"role":51,"phone":52,"phoneExt":53,"email":54},{"type":73,"investigatorFullName":53,"investigatorTitle":53,"investigatorAffiliation":53,"oldNameTitle":53,"oldOrganization":53},"SPONSOR","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":84,"type":85},24,"ESTIMATED","INTERVENTIONAL",[88],"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.",[91,92,93,94,95,96],"Primary Myelofibrosis","Post-polycythemia Vera Myelofibrosis","Post-essential Thrombocythemia Myelofibrosis","Chronic Myelomonocytic Leukemia","Polycythemia Vera","Essential Thrombocytosis",[34,98,99,100],"Pacritinib","JAK2 Inhibition","Myeloproliferative Neoplasm","2024-05-02",{"date":103,"type":104},"2024-05-03","ACTUAL",{"date":106,"type":104},"2024-04-05",{"date":108,"type":85},"2030-08-27",{"name":5,"class":6},1]