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NCT03752099 · ClinicalTrials.gov registry record · Phase 1
To Evaluate Safety and Tolerability of VERU-111 in Men With Advanced Metastatic Castration Resistant Prostate Cancer
A Phase 1 study, sponsored by Veru.
- Terminated
- Registry status
- Phase 1
- Development phase
- 80
- Enrollment target
NCT03752099: Clinical Trial Phase 1 study, sponsored by Veru.
NCT03752099 is a Phase 1 study that was terminated before completion, run by Veru. The registered enrollment target is 80 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03752099, a Phase 1 study, was terminated before completion, sponsored by Veru.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 80 participants
- Enrollment target
Study Summary
Phase 1b - To assess the safety/tolerability of VERU-111 and to determine the maximum tolerated dose of VERU-111 in patients with metastatic, castration resistant prostate cancer who have failed a novel androgen blocking agent therapy (mCRPC). Phase 2 - To estimate the PSA50 response rate, defined as a decline in PSA to ≥50% of baseline level, confirmed with a second measurement at least 3 weeks apart (PCWG3).
Primary Outcome
Patients will be assessed for toxicities at each clinical evaluation. Toxicities will be graded according to CTCAE v5.0 standardized grading scales. The incidence of grade 3-5 toxicities will be reported.Toxicities will be reported as a tabulated table by type and grade.
Interventions
- DRUG VERU-111
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2019-01-18 |
| Est. Completion | 2023-03-15 |
| Phase | Phase 1 |
Why NCT03752099 stopped before completion
NCT03752099 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% higher).
The record links to 0 conditions, and to 1 intervention - of which VERU-111 is the first listed.
NCT03752099 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03752099 about?
NCT03752099 is a clinical study titled "To Evaluate Safety and Tolerability of VERU-111 in Men With Advanced Metastatic Castration Resistant Prostate Cancer". Phase 1b - To assess the safety/tolerability of VERU-111 and to determine the maximum tolerated dose of VERU-111 in patients with metastatic, castration resistant prostate cancer who have failed a novel androgen blocking agent therapy (mCRPC). Phase 2 - To estimate the PSA50 response rate, defined ...
What is the current status of trial NCT03752099?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2019-01-18. Estimated completion is 2023-03-15.
What interventions are being tested in trial NCT03752099?
The interventions under investigation include: VERU-111 (DRUG).
Who is sponsoring clinical trial NCT03752099?
This trial is sponsored by Veru, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03752099's enrollment target sits among peer trials
80 672nd of 2000 higher than 1,305 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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