Study on EPI-7386 and Enzalutamide Combination vs. Enzalutamide Alone for Advanced Prostate Cancer

Sponsor: ESSA Pharmaceuticals

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05075577

Provider View

This clinical trial is testing a new drug combination of EPI-7386 and enzalutamide to see if it is more effective than enzalutamide alone in treating men with advanced prostate cancer that has spread and is resistant to standard hormone therapy.

Patient Parameters

Program Overview

This study is exploring a new treatment for men with advanced prostate cancer that has spread and is resistant to standard hormone therapy. The trial is in two phases. Phase 1 will test the safety and best dose of EPI-7386 when combined with enzalutamide. Phase 2 will compare the effectiveness of the combination treatment against enzalutamide alone. About 120 participants will be involved, with most receiving the combination treatment. Participants will continue treatment as long as it is effective and well-tolerated.

Eligibility Criteria

Inclusion Criteria

  • Men aged 18 or older.
  • Confirmed diagnosis of prostate cancer.
  • Prostate cancer that is resistant to standard hormone therapy.
  • Cancer has spread to bones or soft tissues.
  • Have not used second-generation anti-androgens.
  • Showing signs of cancer progression.
  • Good overall health with an ECOG score of 0 or 1.
  • Ongoing hormone therapy or history of surgery to lower testosterone.
  • Low testosterone levels.
  • Stable use of bone-targeting therapy for at least 28 days before starting the study.
  • Adequate organ function.

Exclusion Criteria

  • Recent use of biological anti-cancer therapy.
  • Recent use of hormonal agents against prostate cancer.
  • Use of herbal or alternative therapies affecting PSA levels.
  • Recent chemotherapy or investigational drugs.
  • Recent use of certain radiotherapy treatments.
  • Recent blood transfusion.
  • Brain disease or metastasis unless stable.
  • Spinal cord compression.
  • Recent diagnosis of another significant cancer.
  • Gastrointestinal issues affecting drug absorption.
  • Significant heart disease.
  • History of seizures or conditions that increase seizure risk.
  • Other significant health issues.
  • Allergies to study drugs.
  • Use of certain medications affecting drug metabolism.
  • Not suitable for enzalutamide treatment.
  • Rare hereditary fructose intolerance.

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