Pacritinib w/ Talazoparib in Pts w/ Myeloproliferative Neoplasms Unresponsive to JAK2 Inhibition

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Fox Chase Cancer Center
Study ID
NCT06218628
Phase
PHASE1
Status
Recruiting
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Conditions

  • Chronic Myelomonocytic Leukemia
  • Essential Thrombocytosis
  • Polycythemia Vera
  • Post-essential Thrombocythemia Myelofibrosis
  • Post-polycythemia Vera Myelofibrosis
  • Primary Myelofibrosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Talazoparib — DRUG
    pacritinib in combination with talazoparib
  • pacritinib — DRUG
    pacritinib in combination with talazoparib

Study Details

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.

Key Dates

Start date
Apr 5, 2024
Status verified
May 2024
Primary completion
Aug 22, 2029
Completion
Aug 27, 2030

Study Design

Enrollment
24 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Level -1
    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)
  • Experimental: 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)
  • Experimental: 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)
  • Experimental: 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)
  • Experimental: 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)

Primary Outcome Measure

Maximum Tolerated Dose (MTD) [ Time Frame: 6 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Fox Chase Cancer Center - PhiladelphiaPhiladelphiaPennsylvania19111-2497
Abigail Protocol Development Coordinator
[email protected]
215-728-2451

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By research site
Fox Chase Cancer Center - Philadelphia· Philadelphia, PA

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