Enzalutamide Plus Everolimus in Men With Metastatic Castrate-Resistant Prostate Cancer
Completed · Phase 1
Conditions studied: Prostate Cancer
In brief
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.
Key facts
- Study ID
- NCT02125084
- Run by
- SCRI Development Innovations, LLC
- People needed
- 38
- Starts
- 2014-10-01
- Expected to finish
- 2021-05-03
- Last updated by the study team
- 2021-05-04
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- KEY POINTS:
- Adenocarcinoma of the prostate confirmed histologically.
- Metastatic disease confirmed by biopsy or imaging studies.
- 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.
- Chemotherapy-naive or previously treated with docetaxel for metastatic prostate cancer.
- ECOG of 0 to 2.
- 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.
- Adequate hematologic, hepatic and renal function.
- Adequate coagulation parameters and serum chemistries.
- Ability to swallow and retain oral medication.
- Life expectancy of 6 months or greater.
- Ability to understand the nature of the study and give written informed consent.
You may not qualify if…
- Treatment with more than 2 prior chemotherapy regimens.
- Previous treatment with enzalutamide or other investigational androgen receptor inhibitors.
- Previous treatment with PI3K/mTOR inhibitors.
- Known hypersensitivity to everolimus or other rapamycins (sirolimus, temsirolimus) or its excipients.
- 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.
- 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.
- CNS metastases.
Where it is running
- Florida Cancer Specialists — Fort Myers, Florida, United States
- Florida Cancer Center — St. Petersburg, Florida, United States
- Oncology Hematology Care Inc. — Cincinnati, Ohio, United States
- Tennessee Oncology — Chattanooga, Tennessee, United States
- Tennessee Oncology PLLC — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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