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Tyrosine kinase inhibitor

Pacritinib + Talazoparib for Myeloproliferative Disorders

Phase 1
Recruiting
Led By Peter Abdelmessieh, DO, MSc
Research Sponsored by Fox Chase Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG (Eastern Cooperative Oncology Group) performance status 0-2
Patients must have normal organ function as defined in protocol
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is a study to find the appropriate dosage of talazoparib when given with pacritinib, a standard treatment. The goal is to determine the maximum tolerated dosage and the recommended

Who is the study for?
This trial is for adults over 18 with certain types of blood disorders like myelofibrosis or chronic leukemia, who've had symptoms measured by the MFSAF v4.0 and are considered intermediate-2/high-risk. They must have tried a JAK2 inhibitor treatment without success and have good organ function. Pregnant women, those with uncontrolled illnesses, recent other cancers, or severe unresolved treatment side effects can't join.
What is being tested?
The study tests different doses of Talazoparib combined with standard pacritinib to find the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D). It's a phase I trial where patients receive escalating doses to assess safety and effectiveness in treating myeloproliferative neoplasms resistant to JAK2 inhibitors.
What are the potential side effects?
Possible side effects include fatigue, bleeding issues due to low platelet counts, digestive problems like nausea or diarrhea, potential heart rhythm abnormalities from QTc prolongation, increased risk of infections due to weakened immune system response from marrow-suppressive therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself and am up and about more than half of my waking hours.
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My organs are functioning normally.
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My myelofibrosis is classified as intermediate-2 or high-risk.
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I am older than 18 years.
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I've been treated with a JAK2 inhibitor for over 12 weeks without improvement, or my spleen has grown significantly.
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I have been diagnosed with a specific type of blood disorder.
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I have severe symptoms of myelofibrosis, scoring 3 or more on at least two symptoms or a total score of 12 or more.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a bleeding stroke or have a bleeding disorder that is not under control.
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I am HIV positive and not on antiretroviral therapy.
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My leukemia has progressed to AML with more than 20% blasts.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximum Tolerated Dose (MTD)
Secondary study objectives
Disease control rate
Overall survival
Progression free survival
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups
Experimental Treatment
Group I: Dose Level 4Experimental Treatment2 Interventions
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)
Group II: Dose Level 3Experimental Treatment2 Interventions
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)
Group III: Dose Level 2Experimental Treatment2 Interventions
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)
Group IV: Dose Level 1Experimental Treatment2 Interventions
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)
Group V: Dose Level -1Experimental Treatment2 Interventions
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)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Talazoparib
2021
Completed Phase 2
~2810

Find a Location

Who is running the clinical trial?

Fox Chase Cancer CenterLead Sponsor
234 Previous Clinical Trials
39,349 Total Patients Enrolled
Peter Abdelmessieh, DO, MScPrincipal InvestigatorFox Chase Cancer Center
~16 spots leftby Aug 2029
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