← Back to Search

Tubulin Inhibitor

VERU-111 for Prostate Cancer (VERACITY Trial)

Phase 3
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 360 days
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

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).

Eligible Conditions
  • Prostate Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~360 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 360 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Therapeutic procedure
Secondary study objectives
Overall Survival

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%
Atrial fibrillation
5%
Bradycardia
5%
Hyperkalemia
5%
Hypernatremia
5%
Anemia
5%
Hypokalemia
5%
Acute respiratory failure
4%
Hypotension
4%
Delirium
3%
Sepsis
3%
Anxiety
3%
COVID-19
2%
Urinary tract infection bacterial
2%
Hypoxia
2%
Hypophosphatemia
2%
Pulmonary sepsis
2%
Cardio-respiratory arrest
2%
Septic shock
2%
Pulmonary embolism
2%
Sepsis Shock
2%
Severe acute respiratory syndrome
1%
Burkholderia cepacia complex infection
1%
Mydriasis
1%
Death
1%
Procedural failure
1%
Infection
1%
Post procedural haemorrhage
1%
Coma
1%
Dyspnoea
1%
Pneumothorax
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%
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Either VERU-111 32mg or 26mg dose will be supplied as capsules 1 orally once a dayExperimental Treatment1 Intervention
32mg of VERU-111 26mg of VERU-11
Group II: Active control alternative androgen receptor targeting agentActive Control1 Intervention
The alternative androgen receptor targeting agent will be administered according to the dosing instructions in the current product prescribing information.
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
647 Total Patients Enrolled
BarnetteStudy ChairVeru Inc.
9 Previous Clinical Trials
623 Total Patients Enrolled

Media Library

VERU-111 (Tubulin Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04844749 — Phase 3
Prostate Cancer Research Study Groups: Either VERU-111 32mg or 26mg dose will be supplied as capsules 1 orally once a day, Active control alternative androgen receptor targeting agent
Prostate Cancer Clinical Trial 2023: VERU-111 Highlights & Side Effects. Trial Name: NCT04844749 — Phase 3
VERU-111 (Tubulin Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04844749 — Phase 3
~24 spots leftby Nov 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top