NCT06218628 Pacritinib w/ Talazoparib in Pts w/ Myeloproliferative Neoplasms Unresponsive to JAK2 Inhibition
| NCT ID | NCT06218628 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Fox Chase Cancer Center |
| Condition | Primary Myelofibrosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2024-04-05 |
| Primary Completion | 2029-08-22 |
Trial Parameters
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 * 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 * Subject classified as intermediate-2 or high-risk MF, as defined by the Dynamic International Prognostic Scoring System Plus (DIPSS+70). * Age \> 18 years. * ECOG (Eastern Cooperative Oncology Group) performance status 0-2 * 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