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Anti-tumor agent

VERU-111 for Prostate Cancer

Phase 1 & 2
Waitlist Available
Research Sponsored by Veru Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 91 days
Awards & highlights

Study Summary

This trial is testing a new drug for prostate cancer that has spread and is no longer responding to hormone therapy. The first part of the trial is to see if the drug is safe and what the highest dose that can be given is. The second part of the trial is to see if the drug can reduce the PSA level in at least 50% of patients.

Eligible Conditions
  • Metastatic Castration Resistant Prostate Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~91 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 91 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Tolerated Dose
PSA50 Response Rate
Secondary outcome measures
Number of participants with treatment related adverse events (Safety and Tolerability)
PSA progression-free survival
Percentage of Patients who achieve Objective Response Rate
+1 more

Side effects data

From 2022 Phase 3 trial • 204 Patients • NCT04842747
10%
Respiratory failure
8%
Acute kidney injury
7%
Constipation
6%
Urinary tract infection
6%
Pneumonia
5%
Bradycardia
5%
Atrial fibrillation
5%
Hyperkalemia
5%
Hypernatremia
5%
Anemia
5%
Hypokalemia
5%
Acute respiratory failure
4%
Hypotension
4%
Delirium
3%
Sepsis
3%
Anxiety
3%
COVID-19
2%
Hypoxia
2%
Urinary tract infection bacterial
2%
Hypophosphatemia
2%
Pulmonary sepsis
2%
Cardio-respiratory arrest
2%
Septic shock
2%
Pulmonary embolism
2%
Sepsis Shock
2%
Severe acute respiratory syndrome
1%
Coma
1%
Death
1%
Procedural failure
1%
Dyspnoea
1%
Mydriasis
1%
Post procedural haemorrhage
1%
Pneumothorax
1%
Infection
1%
Urosepsis
1%
Clostridium difficile colitis
1%
Endocarditis staphylococcal
1%
Enterococcal sepsis
1%
Pneumonia acinetobacter
1%
Stroke in evolution
1%
Shock
1%
Acinetobacter infection
1%
Burkholderia cepacia complex infection
1%
Device related infection
1%
Cerebrovascular accident
1%
Polyneuropathy
1%
Seizure like phenomena
1%
Renal failure
1%
Laryngeal stenosis
1%
Arterial thrombosis
1%
Deep vein thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
9mg of VERU-111 Oral Daily
Placebo Capsule Once Daily

Trial Design

6Treatment groups
Experimental Treatment
Group I: VERU-111 9mgExperimental Treatment1 Intervention
Daily dosing on Day 1-7 of each 21-day cycle for 3 cycles Treatment may continue past the planned three 21-day cycles until DLT or disease progression is observed.
Group II: VERU-111 45mgExperimental Treatment1 Intervention
Daily dosing on Day 1-7 of each 21-day cycle for 3 cycles Treatment may continue past the planned three 21-day cycles until DLT or disease progression is observed.
Group III: VERU-111 4.5mgExperimental Treatment1 Intervention
Daily dosing on Day 1-7 of each 21-day cycle for 3 cycles Treatment may continue past the planned three 21-day cycles until DLT or disease progression is observed.
Group IV: VERU-111 36mgExperimental Treatment1 Intervention
Daily dosing on Day 1-7 of each 21-day cycle for 3 cycles Treatment may continue past the planned three 21-day cycles until DLT or disease progression is observed.
Group V: VERU-111 27mgExperimental Treatment1 Intervention
Daily dosing on Day 1-7 of each 21-day cycle for 3 cycles Treatment may continue past the planned three 21-day cycles until DLT or disease progression is observed.
Group VI: VERU-111 18mgExperimental Treatment1 Intervention
Daily dosing on Day 1-7 of each 21-day cycle for 3 cycles Treatment may continue past the planned three 21-day cycles until DLT or disease progression is observed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VERU-111
2021
Completed Phase 3
~210

Find a Location

Who is running the clinical trial?

Veru Inc.Lead Sponsor
10 Previous Clinical Trials
612 Total Patients Enrolled
BarnetteStudy ChairVeru Inc.
9 Previous Clinical Trials
588 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
To Evaluate Safety and Tolerability of VERU-111 in Men With Advanced Metastatic Castration Resistant Prostate Cancer
2019. "To Evaluate Safety and Tolerability of VERU-111 in Men With Advanced Metastatic Castration Resistant Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03752099.
~13 spots leftby Apr 2025
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