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

Launched by FOX CHASE CANCER CENTER · Jan 12, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with certain blood cancers, specifically types of myelofibrosis and other related conditions that have not responded to standard therapy involving JAK2 inhibitors. The goal is to test the combination of two drugs, pacritinib and talazoparib, to see how well they work together and to determine the best dose for patients. The trial is currently looking for participants aged 18 and older who have specific symptoms and have previously been treated with a JAK2 inhibitor for at least 12 weeks but have not seen improvement.

To be eligible for this study, participants need to have a confirmed diagnosis of one of the specified blood conditions and show significant symptoms that impact their quality of life. They should not be receiving any other experimental treatments and must have normal organ function. If you decide to participate, you can expect to receive careful monitoring and support throughout the trial. This research aims to find new options for patients who currently have limited treatment choices.

Gender

ALL

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.