Actively Recruiting
Pacritinib w/ Talazoparib in Pts w/ Myeloproliferative Neoplasms Unresponsive to JAK2 Inhibition
Led by Fox Chase Cancer Center · Updated on 2024-05-03
24
Participants Needed
1
Research Sites
333 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pacritinib w/ Talazoparib in Pts w/ Myeloproliferative Neoplasms Unresponsive to JAK2 Inhibition
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have confirmed diagnosis of primary myelofibrosis, post-polycythemia vera myelofibrosis, post-essential thrombocythemia myelofibrosis, chronic myelomonocytic leukemia, polycythemia vera, or essential thrombocytosis according to WHO 2008 criteria
- Patient has at least 2 symptoms with a score of 3 or higher or a total symptom score of 12 or more using the Myelofibrosis Symptom Assessment Form v4.0
- Classified as intermediate-2 or high-risk myelofibrosis by the Dynamic International Prognostic Scoring System Plus (DIPSS+70)
- Age over 18 years
- ECOG performance status between 0 and 2
- Prior treatment with a single JAK2 inhibitor for at least 12 weeks with disease progression OR new palpable splenomegaly of at least 5 cm below left costal margin if no prior splenomegaly
- Baseline corrected QT interval less than 0.47 seconds (Bazett formula)
- Normal organ function as defined in the protocol
- Ability to understand and sign informed consent and HIPAA documents
You will not qualify if you...
- Receiving any other investigational agents
- Unresolved toxicity greater than Grade 1 from prior therapy, except sensory neuropathy, alopecia, or fatigue
- Transformation to acute myeloid leukemia with more than 20% blasts in blood or bone marrow
- Uncontrolled illnesses such as other active cancers (except certain cancers in remission), ongoing infections, symptomatic heart failure, unstable angina, uncontrolled arrhythmias, or psychiatric/social issues limiting study compliance
- History of hemorrhagic stroke or uncontrolled bleeding disorders
- Known HIV positive and on combination antiretroviral therapy
- Pregnant or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States, 19111-2497
Actively Recruiting
Research Team
A
Abigail Protocol Development Coordinator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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