Titre A Phase 1/2 Study of EPI-7386 in Combination With Enzalutamide Compared With Enzalutamide Alone in Subjects With Metastatic Castration-Resistant Prostate Cancer
Protocole ID EPI-7386-CS-010
ClinicalTrials.gov ID NCT05075577
Type(s) de cancer Prostate
Phase Phase I-II
Stade Résistant à la castration - métastatique
Type étude Clinique
Médicament EPI-7386 en association avec enzalutamide comparé à enzalutamide seul
Institution CENTRE HOSPITALIER DE L'UNIVERSITE DE MONTREAL  
Ville Montréal
Investigateur(trice) principal(e) Dr Fred Saad
Coordonnateur(trice) Amal Nadiri
 514-890-8000 poste 26074
Statut Actif en recrutement
Date d'activation 20-06-2023
Critètes d'éligibilité
  • Males ≥18 years.
  • Histologically, pathologically, or cytologically confirmed prostate adenocarcinoma.
  • Evidence of castration-resistant prostate cancer (CRPC).
  • Presence of metastatic disease at study entry documented by 1 or more bone lesions on bone scan or by soft tissue disease observed by CT/MRI.
  • Naïve to second generation anti-androgens.
  • Evidence of progressive disease defined as 1 or more Prostate Cancer Working Group 3 (PCWG3) criteria.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Ongoing ADT with luteinizing hormone-releasing hormone (LHRH) agonist/antagonist therapy or history of bilateral orchiectomy, with castrate level testosterone.
  • Serum testosterone ≤1.73 nmol/L (50 ng/dL).
  • Subjects receiving bisphosphonates or other approved bone-targeting therapy (e.g., denosumab) must be on a stable dose for at least 28 days prior to the start of study treatment.
  • Demonstrate adequate organ function.
Critètes d'exclusion
  • Biologic anti-cancer therapy within 28 days prior to the start of study treatment.
  • Use of hormonal agents with anti-tumor activity against prostate cancer within 28 days prior to the start of study treatment.
  • Use of herbal products or alternative therapies that may decrease PSA levels or that may have hormonal anti-prostate cancer activity within 28 days prior to the start of study treatment or plans to initiate during the study.
  • Intervention with any chemotherapy, investigational agents, or other anti-cancer drugs within 28 days of the first dose of study treatment.
  • Use of radium-223 dichloride or other radioligand/radiopharmaceutical within 28 days prior to the start of study treatment.
  • Received limited-field palliative bone radiotherapy >5 fractions and/or any radiotherapy within 2 weeks prior to the start of study treatment.
  • Received a blood transfusion within 28 days of hematologic screening labs.
  • Known intra-cerebral disease or brain metastasis unless adequately treated and stable for the last 28 days before signing of informed consent.
  • Spinal cord compression.
  • Diagnosis of another clinically significant malignancy within the previous 3 years other than curatively treated non-melanomatous skin cancer or superficial urothelial carcinoma and other in situ or non-invasive malignancies.
  • Gastrointestinal issues affecting absorption.
  • Significant cardiovascular disease.
  • Known history of seizure or conditions that may pre-dispose them to seizure, including brain injury with loss of consciousness, transient ischemic attack within the past 12 months, cerebral vascular accident, brain metastases, and brain arteriovenous malformation.
  • Concurrent disease or any clinically significant abnormality.
  • Known or suspected hypersensitivity to any components of the formulation used for EPI-7386 or enzalutamide.
  • Use of strong inhibitors of CYP2C8.
  • Use of strong inducers of CYP3A.
  • Use of narrow therapeutic index sensitive CYP2C8 or sensitive substrates for CYP3A and CYP2B6.
  • Use of granulocyte colony stimulating factor within 7 days prior to screening laboratories.
  • Not a candidate for enzalutamide treatment.
  • Patients with rare hereditary problems of fructose intolerance.