Efficacy Evaluation of VERU-111 for mCRPC in Patients Who Have Failed at Least One Androgen Receptor Targeting Agent

(VERACITY Trial)

Recruiting at 50 trial locations

Overseen By Rodriguez

Age: 18+

Sex: Male

Trial Phase: Phase 3

Sponsor: Veru Inc.

Must be taking: Androgen deprivation therapy

Must not be taking: Warfarin, Taxane chemotherapy

Disqualifiers: Small cell carcinoma, Brain metastases, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Approximately 52 weeks

105 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called VERU-111 for patients with advanced prostate cancer that hasn't responded to standard treatments. The drug aims to stop cancer cells from growing by disrupting their internal structures. VERU-111 is also being tested for its effectiveness in treating triple-negative breast cancer (TNBC).

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications. However, you must continue androgen deprivation therapy (ADT) if you are already on it.

Research Team

Barnette

Principal Investigator

Veru Inc.

Eligibility Criteria

Inclusion Criteria

Known castration resistant prostate cancer, defined according to PCWG3 criteria.

Absolute PSA ≥2.0 ng/ml at screening.

Provide informed consent.

Exclusion Criteria

Patients with a QT interval corrected by Fridericia's formula of >480 ms

Patients receiving full dose warfarin therapy are not eligible for study

Patients with prior history of a thromboembolic event within the last 6 months

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive VERU-111 or an alternative androgen receptor targeting agent until radiographic progression is observed

Approximately 52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• VERU-111

Participant Groups

Group I: Either VERU-111 32mg or 26mg dose will be supplied as capsules 1 orally once a day Experimental Treatment 1 Intervention

32mg of VERU-111 26mg of VERU-11

Group II: Active control alternative androgen receptor targeting agent Active Control 1 Intervention

The alternative androgen receptor targeting agent will be administered according to the dosing instructions in the current product prescribing information.

Who Is Running the Clinical Trial?

Veru Inc.

Lead Sponsor

Trials

11

Recruited

750+