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Pacritinib with Talazoparib for Myeloproliferative Neoplasms

This study is testing a new combination of two drugs, pacritinib and talazoparib, for people with certain blood cancers called myeloproliferative neoplasms (like primary myelofibrosis or polycythemia vera). These are people whose disease has not responded to or who cannot tolerate other treatments for JAK2. The main goal is to find the highest safe dose of talazoparib when given with standard pacritinib. You would first take pacritinib for a week, then add talazoparib. The study is currently recruiting about 24 participants. Success for this study means identifying the best dose of talazoparib to use in future research.

Study design
This is a Phase 1 dose-escalation study, meaning it starts with a low dose and gradually increases it. It is an interventional study, and about 24 participants are planned.
What's involved
You would need to have a bone marrow biopsy at the start of the study. You would take pacritinib daily, followed by talazoparib. If you are on a JAK2-directed therapy, you will have a one-day break before starting this study.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, Maximum Tolerated Dose, is measured at 6 years, suggesting long-term follow-up.

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NCT06218628

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Fox Chase Cancer Center
~24 participants
Updated 2024-05-03 on ClinicalTrials.gov
What's tested:Talazoparibpacritinib

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum Tolerated Dose (MTD)
Measured over 6 years

Conditions

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

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Where it's being run

1 sites across 1 states
Pennsylvania1

Study leadership

  • Peter Abdelmessieh, DO, MSc · PRINCIPAL_INVESTIGATOR · Fox Chase Cancer Center

Who to contact

Abigail Protocol Development Coordinator
[email protected]
215-728-2451
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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 evidence of splenomegaly prior to the initiation of any first line JAK2 inhibitor
Baseline QTc (corrected QT interval) \<0.47 seconds (Bazett formula)
Patients must have normal organ function as defined in protocol.
Ability to understand and willingness to sign a written informed consent and HIPAA consent document

Exclusion

Patients may not be receiving any other investigational agents
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.
Patients that have transformed to Acute Myeloid Leukemia defined by \>20% blasts count on peripheral blood smear or bone marrow biopsy evaluation
Uncontrolled inter-current illness including, but not limited to, any other malignancy (with the exception of hormonal therapy for breast cancer/prostate 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/social situations that would limit compliance with study requirements.
Patients with history of hemorrhagic stroke and evidence of uncontrolled bleeding as well as bleeding disorder
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.
Pregnant or breast-feeding.

What this trial measures

  • Maximum Tolerated Dose (MTD)6 years

    To define the maximum tolerated dose (MTD) of talazoparib in combination with standard of care dosing of pacritinib in order to establish a recommended phase II dose (RP2D).