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NCT02090114 · ClinicalTrials.gov registry record · Phase 2
RE-sensitizing With Supraphysiologic Testosterone to Overcome REsistance (The RESTORE Study)
A Phase 2 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Completed
- Registry status
- Phase 2
- Development phase
- 112
- Enrollment target
NCT02090114 is a Phase 2 study that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 112 participants.
The verdict
NCT02090114, a Phase 2 study, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 112 participants
- Enrollment target
Study Summary
Single-arm, single site, open label study of the effects of parenteral testosterone followed by enzalutamide, abiraterone or castration-only therapy in men with metastatic CRPC who previously progressed on one of these forms of therapy. The study will enroll four cohorts of patients: men with metastatic CRPC who have progressed on enzalutamide (Cohort A; n=30); men with metastatic CRPC who have progressed on abiraterone acetate (Cohort B; n=30); men with metastatic CRPC who have progressed on first line castration-only therapy (Cohort C; n=30); men with metastatic CRPC with inactivating somatic or germline mutations in ≥2 of the genes TP53, PTEN, or RB1 (Cohort D; n=20).
Interventions
- DRUG Testosterone cypionate
- DRUG Enzalutamide
- DRUG Abiraterone acetate
- DRUG Testosterone Enanthate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2014-08-25 |
| Est. Completion | 2021-11-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02090114
The ClinicalTrials.gov registry entry for NCT02090114 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 112 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Testosterone cypionate is the first listed.
NCT02090114 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02090114 about?
NCT02090114 is a clinical study titled "RE-sensitizing With Supraphysiologic Testosterone to Overcome REsistance (The RESTORE Study)". Single-arm, single site, open label study of the effects of parenteral testosterone followed by enzalutamide, abiraterone or castration-only therapy in men with metastatic CRPC who previously progressed on one of these forms of therapy. The study will enroll four cohorts of patients: men with metast...
What is the current status of trial NCT02090114?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 112 participants. The study started on 2014-08-25. Estimated completion is 2021-11-11.
What interventions are being tested in trial NCT02090114?
The interventions under investigation include: Testosterone cypionate (DRUG), Enzalutamide (DRUG), Abiraterone acetate (DRUG), Testosterone Enanthate (DRUG).
Who is sponsoring clinical trial NCT02090114?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
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