Pacritinib in Participants With Metastatic Castrate-Resistant Prostate Cancer That Progressed on … (NCT07226713) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Pacritinib in Participants With Metastatic Castrate-Resistant Prostate Cancer That Progressed on or After Prior Treatment With Androgen Receptor Signaling Inhibitors
United States32 participantsStarted 2026-07-01
Plain-language 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
Who can participate
Age range18 Years
SexMALE
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Inclusion criteria
✓. Patients aged ≥ 18 years.
✓. Histologically or cytologically confirmed prostate adenocarcinoma.
✓. Have current evidence of metastatic disease documented by either bone scan, CT/MRI and/or PSMA PET scan
✓. 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 or nmHSPC) or mCRPC.
✓. Screening serum testosterone \< 50 ng/dL.
✓. Eastern Cooperative Oncology Group (ECOG), Performance Status grade 0-1 or Karnofsky Performance Status ≥ 70
✓. No prior janus kinase2 (JAK2) inhibitor treatment.
✓. Left ventricular cardiac ejection fraction of ≥ 50% by echocardiogram or multigated acquisition (MUGA) scan.
Exclusion criteria
✕. Patient does not have positive STAT5 activation status in PC core biopsies.
✕. Previously treated with pacritinib.
✕. Use of investigational agents within 28 days prior to randomization.
✕. Use of other prohibited medications within seven days prior to Cycle 1, Day 1 or 5x half-life of the drug, whichever is longer.
What they're measuring
1
Progression-free Survival
Timeframe: Six months
Trial details
NCT IDNCT07226713
SponsorMedical College of Wisconsin
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2029-03-01
Contact for this trial
Medical College of Wisconsin Cancer Center Clinical Trials Office
✕. Systemic treatment with a strong CYP3A4 inhibitor or inducer within 14 days prior to the start of treatment.
✕. Uncontrolled hypertension.
✕. Baseline severe hepatic impairment (Child-Pugh Class B \& C).
✕. An intercurrent illness that is not controlled, such as active infection, psychiatric illness, or social situations that would limit compliance with study requirements.