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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 is a Phase 1 study that was terminated before completion, run by Veru. The registered enrollment target is 80 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03752099
The ClinicalTrials.gov registry entry for NCT03752099 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Veru, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which VERU-111 is the first listed.
NCT03752099 reports 0 study locations.
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.
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