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Tyrosine kinase inhibitor

Dose Level -1 for Myelofibrosis

Phase 1

Waitlist Available

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum Tolerated Dose (MTD)

Secondary outcome measures

Disease control rate

Overall survival

Progression free survival

+2 more

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

~2770

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Fox Chase Cancer CenterLead Sponsor

227 Previous Clinical Trials

37,485 Total Patients Enrolled

Peter Abdelmessieh, DO, MScPrincipal InvestigatorFox Chase Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals still eligible to participate in this ongoing research?

"According to the information provided by clinicaltrials.gov, this trial is currently not accepting new participants. The study was first posted on April 1st, 2024 and last updated on January 12th, 2024. However, it's worth noting that there are currently numerous other studies actively recruiting participants—specifically, a total of 2,682 trials."

Answered by AI

What is the safety profile of Dose Level -1 in individuals?

"Based on the assessment by our team at Power, Dose Level -1 is rated as a 1 for safety. This rating aligns with it being a Phase 1 trial, where there is limited available data supporting both safety and efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Pacritinib w/ Talazoparib in Pts w/ Myeloproliferative Neoplasms Unresponsive to JAK2 Inhibition". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06218628.

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