| 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.
|
Groupe d'étude en oncologie du Québec