24 Participants Needed

Pacritinib + Talazoparib for Myeloproliferative Disorders

AP
Overseen ByAbigail Protocol Development Coordinator
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Fox Chase Cancer Center
Must be taking: JAK2 inhibitors
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot be on other investigational drugs. It's best to discuss your specific medications with the trial team.

Is the combination of Pacritinib and Talazoparib safe for humans?

Talazoparib has been studied in patients with advanced breast cancer and other solid tumors, showing some side effects like fatigue, low blood cell counts, and anemia. These studies suggest that while Talazoparib can be effective, it may also cause significant side effects, especially in people with certain genetic mutations.12345

How is the drug combination of Pacritinib and Talazoparib unique for treating myeloproliferative disorders?

This drug combination is unique because it combines Pacritinib, which is a kinase inhibitor, with Talazoparib, a PARP inhibitor that helps prevent cancer cells from repairing their DNA, potentially offering a novel approach to treating myeloproliferative disorders by targeting different pathways involved in cancer cell survival.46789

What data supports the effectiveness of the drug Talazoparib?

Talazoparib has shown effectiveness in treating advanced breast cancer with specific genetic mutations, improving progression-free survival compared to chemotherapy. It also demonstrated antitumor activity in prostate cancer with certain DNA repair alterations.146710

Who Is on the Research Team?

PA

Peter Abdelmessieh, DO, MSc

Principal Investigator

Fox Chase Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I can take care of myself and am up and about more than half of my waking hours.
My organs are functioning normally.
My myelofibrosis is classified as intermediate-2 or high-risk.
See 6 more

Exclusion Criteria

Pregnant or breast-feeding
My side effects from previous treatments are mild, except for possible nerve pain, hair loss, and tiredness.
I don't have any serious illnesses or conditions that would stop me from following the study's requirements.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Lead-in Phase

Pacritinib is initiated on day -7 with a standard of care dose of 200mg twice daily

1 week
1 visit (in-person)

Treatment

Talazoparib is administered in combination with pacritinib, with dose escalation to determine the maximum tolerated dose

28 days per cycle
4 visits (in-person) per cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Pacritinib
  • Talazoparib
Trial Overview 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.
How Is the Trial Designed?
5Treatment groups
Experimental Treatment
Group I: Dose Level 4Experimental Treatment2 Interventions
Group II: Dose Level 3Experimental Treatment2 Interventions
Group III: Dose Level 2Experimental Treatment2 Interventions
Group IV: Dose Level 1Experimental Treatment2 Interventions
Group V: Dose Level -1Experimental Treatment2 Interventions

Pacritinib is already approved in United States for the following indications:

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Approved in United States as Vonjo for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Fox Chase Cancer Center

Lead Sponsor

Trials
236
Recruited
39,300+

Published Research Related to This Trial

Talazoparib is an oral PARP inhibitor recently approved in the USA for treating adults with specific types of breast cancer, particularly those with BRCA mutations, highlighting its targeted efficacy in a defined patient population.
The drug is also being explored for use in other cancers, including metastatic castration-resistant prostate cancer and early triple negative breast cancer, indicating its potential versatility in cancer treatment.
Talazoparib: First Global Approval.Hoy, SM.[2020]
In a phase Ib trial involving 22 patients with metastatic pancreatic ductal adenocarcinoma, combinations of avelumab or talazoparib with binimetinib showed higher-than-expected rates of dose-limiting toxicity (DLT), particularly at the 45 mg dose, leading to dose adjustments.
Despite the safety concerns, the overall safety profiles of the combinations were consistent with those of the individual drugs, but no objective tumor responses were observed in the study.
Avelumab or talazoparib in combination with binimetinib in metastatic pancreatic ductal adenocarcinoma: dose-finding results from phase Ib of the JAVELIN PARP MEKi trial.Rodon Ahnert, J., Tan, DS., Garrido-Laguna, I., et al.[2023]
In the TALAPRO-1 study involving 97 men with metastatic castration-resistant prostate cancer (mCRPC), talazoparib significantly improved health-related quality of life (HRQoL) and reduced pain levels, particularly in patients with BRCA1/2 mutations.
The study found that 84% of all patients and 83% of those with BRCA1/2 mutations did not experience a deterioration in worst pain after 12 months of treatment, indicating a high probability of maintaining pain relief while receiving talazoparib.
Patient-reported Outcomes in Men with Metastatic Castration-resistant Prostate Cancer Harboring DNA Damage Response Alterations Treated with Talazoparib: Results from TALAPRO-1.Saad, F., de Bono, J., Barthélémy, P., et al.[2023]

Citations

Talazoparib: First Global Approval. [2020]
Avelumab or talazoparib in combination with binimetinib in metastatic pancreatic ductal adenocarcinoma: dose-finding results from phase Ib of the JAVELIN PARP MEKi trial. [2023]
Patient-reported Outcomes in Men with Metastatic Castration-resistant Prostate Cancer Harboring DNA Damage Response Alterations Treated with Talazoparib: Results from TALAPRO-1. [2023]
Quality of life with talazoparib after platinum or multiple cytotoxic non-platinum regimens in patients with advanced breast cancer and germline BRCA1/2 mutations: patient-reported outcomes from the ABRAZO phase 2 trial. [2021]
Talazoparib versus chemotherapy in patients with germline BRCA1/2-mutated HER2-negative advanced breast cancer: final overall survival results from the EMBRACA trial. [2023]
Differential Toxicity in Patients with and without DNA Repair Mutations: Phase I Study of Carboplatin and Talazoparib in Advanced Solid Tumors. [2018]
Outcomes in Clinically Relevant Patient Subgroups From the EMBRACA Study: Talazoparib vs Physician's Choice Standard-of-Care Chemotherapy. [2022]
Talazoparib in Patients with Advanced Breast Cancer and a Germline BRCA Mutation. [2023]
A Phase I trial of talazoparib in patients with advanced hematologic malignancies. [2022]
PARP inhibitors combined with ionizing radiation induce different effects in melanoma cells and healthy fibroblasts. [2021]
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