A Single-Arm, Open-label, Phase II Study Evaluating Pacritinib in Participants With Metastatic Castrate-Resistant Prostate Cancer That Progressed on or After Prior Treatment With Androgen Receptor Signaling Inhibitors - (POSTPONE)

Medical College of Wisconsin

Summary

This is a single-arm, open-label phase 2 study to evaluate the role of pacritinib for patients with metastatic castrate-resistant prostate cancer that have progressed on ARSI. Patients will receive pacritinib 200 mg twice daily. To be eligible, patients must have a biopsy of a metastatic site within 30 days of treatment that demonstrates positive STAT5 activation status

Eligibility

Age range: 18+ years
Sex: Male
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: I. To be eligible for screening: 1. Patients aged ≥ 18 years. 2. Histologically or cytologically confirmed prostate adenocarcinoma. 3. Have current evidence of metastatic disease documented by either bone scan, CT/MRI and/or PSMA PET scan 4. Have disease that progressed while receiving androgen deprivation therapy (ADT) (or post bilateral orchiectomy) and during or after treatment with at least one androgen receptor signaling inhibitor (ARSI) (e.g., abiraterone acetate, enzalutamide, apalutamide, darolutamide) for metastatic hormone-sensitive prostate cancer (HSPC) (mHSPC…

Interventions

Drug
Pacritinib
Pacritinib is an oral drug which will be taken daily at a dose of 200 mg twice a day (BID).

Location

Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin
dkilari@mcw.edu 414-805-4600

A Single-Arm, Open-label, Phase II Study Evaluating Pacritinib in Participants With Metastatic Castrate-Resistant Prostate Cancer That Progressed on or After Prior Treatment With Androgen Receptor Signaling Inhibitors - (POSTPONE)

Summary

Eligibility

Interventions

Location

Compensation

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Details

Conditions