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NCT03437941 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate Exicorilant (CORT125281) in Combination With Enzalutamide in Patients With Metastatic Castration-Resistant Prostate Cancer
A Phase 1 study, sponsored by Corcept Therapeutics.
- Terminated
- Registry status
- Phase 1
- Development phase
- 39
- Enrollment target
NCT03437941: Clinical Trial Phase 1 study, sponsored by Corcept Therapeutics.
NCT03437941 is a Phase 1 study that was terminated before completion, run by Corcept Therapeutics. The registered enrollment target is 39 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03437941, a Phase 1 study, was terminated before completion, sponsored by Corcept Therapeutics.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 39 participants
- Enrollment target
Study Summary
This study consists of a dose escalation study with an expansion phase to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD), and preliminary efficacy of exicorilant (CORT125281) in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) to identify a recommended dose (RD) for Phase 2 studies.
Primary Outcome
Assess the maximum tolerated dose (MTD) and/or biologically active doses of exicorilant in combination with enzalutamide to identify the recommended dose (RD) for Phase 2 studies based on the number of patients who experienced a DLT while receiving exicorilant in combination with enzalutamide. DLTs were defined as any of the protocol-specified toxicities that the Investigator considered possibly or probably related to study drug that occurred during the DLT-evaluation period. The MTD is defined
Interventions
- DRUG Placebo
- DRUG Enzalutamide
- DRUG Exicorilant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2018-02-20 |
| Est. Completion | 2023-01-12 |
| Phase | Phase 1 |
Why NCT03437941 stopped before completion
NCT03437941 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03437941 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03437941 about?
NCT03437941 is a clinical study titled "Study to Evaluate Exicorilant (CORT125281) in Combination With Enzalutamide in Patients With Metastatic Castration-Resistant Prostate Cancer". This study consists of a dose escalation study with an expansion phase to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD), and preliminary efficacy of exicorilant (CORT125281) in combination with enzalutamide in patients with metastatic castration-resistant prosta...
What is the current status of trial NCT03437941?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2018-02-20. Estimated completion is 2023-01-12.
What interventions are being tested in trial NCT03437941?
The interventions under investigation include: Placebo (DRUG), Enzalutamide (DRUG), Exicorilant (DRUG).
Who is sponsoring clinical trial NCT03437941?
This trial is sponsored by Corcept Therapeutics, which has 54 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03437941's enrollment target sits among peer trials
39 1191st of 2000 higher than 804 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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