To Evaluate Safety and Tolerability of VERU-111 in Men With Advanced Metastatic Castration Resistant Prostate Cancer
Public ClinicalTrials.gov record NCT03752099. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1b/2 Study to Evaluate the Safety and Tolerability of VERU-111 in Men With Advanced Metastatic Castration Resistant Prostate Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT03752099
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 80 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 18, 2019 (Actual)
- Primary completion
- Mar 15, 2023 (Actual)
- Completion
- Mar 15, 2023 (Actual)
- Last update posted
- Sep 26, 2023
2019 – 2023
United States locations
- U.S. sites
- 13
- U.S. states
- 10
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Colorado Urology | Golden | Colorado | 80401 | — |
| Universal Axon | Miami | Florida | 33166 | — |
| First Urology | Jeffersonville | Indiana | 47130 | — |
| Regional Urology | Shreveport | Louisiana | 71106 | — |
| Sidney Kimmel Comprehensive Cancer Center at John Hopkins | Baltimore | Maryland | 21231 | — |
| Chesapeake Urology | Towson | Maryland | 21204 | — |
| Associated Medical Professionals of NY, PLLC | Syracuse | New York | 13210 | — |
| Sargon Research | Canton | Ohio | 44718 | — |
| Urologic Consultants | Bala-Cynwyd | Pennsylvania | 19004 | — |
| Urology Clinics of North Texas | Dallas | Texas | 75231 | — |
| Research Network America | Houston | Texas | 77074 | — |
| Urology San Antonio | San Antonio | Texas | 78229 | — |
| Urology of Virginia | Virginia Beach | Virginia | 23462 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03752099, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 26, 2023 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03752099 live on ClinicalTrials.gov.