Enzalutamide Plus Everolimus in Men With Metastatic Castrate-Resistant Prostate Cancer

• Status: Completed
• Trial end date: 2021-05-03
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to determine the safety and efficacy of a novel combination of agents, enzalutamide and everolimus, for the treatment of patients with metastatic castrate-resistant prostate cancer who have never received prior chemotherapy, or who have previously received docetaxel chemotherapy and have progressive disease.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SCRI Development Innovations, LLC
• Collaborator: Novartis Pharmaceuticals
• Treatments: Everolimus; Sirolimus

Criteria

Inclusion Criteria:

KEY POINTS:

1. Adenocarcinoma of the prostate confirmed histologically.

2. Metastatic disease confirmed by biopsy or imaging studies.

3. Castrate-resistant prostate cancer (i.e., progression of prostate cancer while receiving standard androgen ablation therapy, orchiectomy or luteinizing hormone-releasing hormone [LHRH] antagonist). Castrate levels of serum testosterone must be documented at progression in patients who have not had an orchiectomy.

4. Chemotherapy-naive or previously treated with docetaxel for metastatic prostate cancer.

5. ECOG of 0 to 2.

6. Patients must have progressive metastatic prostate cancer by at least 1 of the following criteria:

• Progression of measurable lesions defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

• Bone progression defined by 2 or more new lesions on bone scan.

• PSA progression is determined by a minimum of two rising PSA levels with an interval of 1 week or greater between each determination. The screening PSA measurement (documenting progression) must be greater than or equal to 2 ng/mL.

7. Adequate hematologic, hepatic and renal function.

8. Adequate coagulation parameters and serum chemistries.

9. Ability to swallow and retain oral medication.

10. Life expectancy of 6 months or greater.

11. Ability to understand the nature of the study and give written informed consent.

Exclusion Criteria:

1. Treatment with more than 2 prior chemotherapy regimens.

2. Previous treatment with enzalutamide or other investigational androgen receptor inhibitors.

3. Previous treatment with PI3K/mTOR inhibitors.

4. Known hypersensitivity to everolimus or other rapamycins (sirolimus, temsirolimus) or its excipients.

5. Use of an investigational drug within 21 days or 5 half-lives (whichever is shorter) prior to the first dose of study drug. For investigational drugs for which 5 half-lives is less than 21 days, a minimum of 10 days between termination of the investigational drug and administration of study drug is required.

6. Most recent chemotherapy ≤21 days from first dose of study treatment and/or patient did not recover from most recent chemotherapy side effects prior to study entry.

7. CNS metastases.