Study on Pacritinib for Metastatic Castrate-Resistant Prostate Cancer After Androgen Receptor Treatment

Sponsor: Medical College of Wisconsin

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT07226713

This clinical trial is testing the drug pacritinib for men with metastatic castrate-resistant prostate cancer that has progressed after treatment with androgen receptor signaling inhibitors. Participants will take pacritinib twice daily, and must have a biopsy showing specific cancer cell activity to join the study.

Patient Parameters

Program Overview

This study aims to evaluate the effectiveness of pacritinib in treating men with metastatic castrate-resistant prostate cancer that has worsened after previous treatments targeting androgen receptors. Participants will take pacritinib 200 mg twice a day. To qualify, a biopsy from a metastatic site within 30 days before starting treatment must show positive STAT5 activation, indicating specific cancer cell activity.

Eligibility Criteria

Inclusion Criteria

  • Men aged 18 years or older.
  • Confirmed diagnosis of prostate adenocarcinoma.
  • Evidence of cancer spread to other parts of the body, confirmed by scans.
  • Cancer that has progressed during or after hormone therapy and treatment with at least one androgen receptor signaling inhibitor.
  • Low testosterone levels (less than 50 ng/dL).
  • Good overall health with a performance status score of 0-1.
  • No previous treatment with JAK2 inhibitors.
  • Heart function with an ejection fraction of 50% or higher.
  • Adequate organ function based on specific blood tests.
  • Willingness to use effective birth control methods during the study and for 30 days after the last dose.
  • Ability to understand and sign a consent form.
  • Provide a tumor sample from a recent biopsy showing high STAT5 activation levels.

Exclusion Criteria

  • No positive STAT5 activation in cancer cell biopsies.
  • Previous treatment with pacritinib.
  • Use of experimental drugs within 28 days before starting the study.
  • Use of certain medications within seven days before starting the study.
  • Uncontrolled high blood pressure.
  • Severe liver problems.
  • Uncontrolled illnesses or conditions that could interfere with the study.
  • Recent significant bleeding issues.
  • Use of medications that increase bleeding risk or affect heart rhythm within 14 days before starting the study.
  • History of serious heart conditions within six months before starting the study.
  • Heart rhythm issues or heart failure.
  • Conditions affecting the absorption of oral medication.
  • Other cancers within three years, except for certain skin cancers.
  • Active infections like HIV or hepatitis.

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