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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.

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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

FieldValue
Enrollment Target 80 participants
Start Date 2019-01-18
Est. Completion 2023-03-15
Phase Phase 1

Sponsor

Veru

10 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.