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NCT02125084 · ClinicalTrials.gov registry record · Phase 1
Enzalutamide Plus Everolimus in Men With Metastatic Castrate-Resistant Prostate Cancer
A Phase 1 study, sponsored by SCRI Development Innovations.
- Completed
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
NCT02125084: Completed Phase 1 study, sponsored by SCRI Development Innovations.
NCT02125084 is a Phase 1 study that has completed, run by SCRI Development Innovations. The registered enrollment target is 38 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02125084, a Phase 1 study, has completed, sponsored by SCRI Development Innovations.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 38 participants
- Enrollment target
Study 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.
Primary Outcome
MTD will be determined by testing increasing doses of everolimus with standard dose enzalutamide in 3-patient dose escalation cohorts. The MTD is defined as the highest dose at which ≤1 of 6 patients experiences a dose-limiting toxicity (DLT) during 1 cycle (28 days) of therapy, assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
Interventions
- DRUG Everolimus
- DRUG Enzalutamide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2014-10 |
| Est. Completion | 2021-05-03 |
| Phase | Phase 1 |
What the finished NCT02125084 record still lists
NCT02125084 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower).
The record links to 0 conditions, and to 2 interventions - of which Everolimus is the first listed.
NCT02125084 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02125084 about?
NCT02125084 is a clinical study titled "Enzalutamide Plus Everolimus in Men With Metastatic Castrate-Resistant Prostate Cancer". 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 chem...
What is the current status of trial NCT02125084?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2014-10. Estimated completion is 2021-05-03.
What interventions are being tested in trial NCT02125084?
The interventions under investigation include: Everolimus (DRUG), Enzalutamide (DRUG).
Who is sponsoring clinical trial NCT02125084?
This trial is sponsored by SCRI Development Innovations, which has 146 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02125084's enrollment target sits among peer trials
38 1197th of 2000 higher than 797 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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