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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 24 participants in total. It began in 2024-04-05 with a primary completion date of 2029-08-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria: * 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.
Contact & Investigator
Peter Abdelmessieh, DO, MSc
PRINCIPAL INVESTIGATOR
Fox Chase Cancer Center
Frequently Asked Questions
Who can join the NCT06218628 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Primary Myelofibrosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06218628 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06218628 currently recruiting?
Yes, NCT06218628 is actively recruiting participants. Contact the research team at abigail.okeefe@fccc.edu for enrollment information.
Where is the NCT06218628 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT06218628 clinical trial?
NCT06218628 is sponsored by Fox Chase Cancer Center. The principal investigator is Peter Abdelmessieh, DO, MSc at Fox Chase Cancer Center. The trial plans to enroll 24 participants.