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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

VERACITY Trial Summary

This trial is testing whether a new drug, VERU-111, can help treat patients with metastatic prostate cancer that has gotten worse despite other treatments.

Eligible Conditions
  • Metastatic Castration Resistant Prostate Cancer
  • Prostate Cancer

VERACITY Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Therapeutic procedure
Secondary outcome measures
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%
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

VERACITY 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
587 Total Patients Enrolled
BarnetteStudy ChairVeru Inc.
9 Previous Clinical Trials
563 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How does VERU-111 compare to other cancer treatments in terms of risk?

"VERU-111 is a Phase 3 trial medication, meaning that while there is some efficacy data supporting its use, there are multiple rounds of safety data. Because of this our team has given it a score of 3 in terms of safety."

Answered by AI

Are there any spots still available in this trial for new patients?

"That is correct, the website clinicaltrials.gov has information indicating that this trial is looking for more participants. The exact number of patients they are trying to enroll is 245 individuals, and there are 52 different hospitals or clinics where the trial is taking place."

Answered by AI

What are the most common maladies that doctors use VERU-111 to address?

"VERU-111 is an effective treatment for three different types of prostate cancer: non-metastatic, castration, and non-mestatatic castrate-resistant."

Answered by AI

Are there any restrictions for patients who want to participate in this research?

"This study is looking for 245 men, aged 18 to 100, who currently have castration-resistant prostatic cancer. In addition to meeting the age criteria, participants must also: provide informed consent, be able to communicate effectively with study personnel, have histological or cytologic proof of adenocarcinoma of the prostate (not small cell carcinoma or neuroendocrine pathology), have radiographic evidence of metastatic disease at baseline by CT scan or MRI and bone scan, with confirmation of measurable disease by RECIST 1.1 and/or identifiable discrete bone metastases by PCWG3, know that they have castration"

Answered by AI

Does this research trial allow for participants who are over thirty years of age?

"The age range for eligible participants in this clinical trial is 18 to 100 years old."

Answered by AI

Yes, can you tell us about the previous research on VERU-111?

"VERU-111 was first studied in 2005 at the Rosemere Cancer Centre.193 clinical trials have been completed since then, with 223 additional trials currently underway. The majority of these ongoing studies are taking place in Merriam, Kansas."

Answered by AI

What is the total number of participants in this research project?

"Veru Inc., the sponsor of this study, needs to enroll 245 eligible patients from a variety of clinical trial sites. Two examples of these participating locations are MidAmerica Cancer Care in Merriam, Kansas and Boca Raton Clinical Research (BRCR) Global USA in Plantation, Florida."

Answered by AI

Could you please tell me how many research facilities are conducting this experiment?

"Currently, patients can enroll at MidAmerica Cancer Care in Merriam, Kansas; Boca Raton Clinical Research (BRCR) Global USA in Plantation, Florida; Centers for Advanced Urology, LLP MidLantic Urology in Bala-Cynwyd, Pennsylvania; and 52 other locations."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Efficacy Evaluation of VERU-111 for mCRPC in Patients Who Have Failed at Least One Androgen Receptor Targeting Agent
2021. "Efficacy Evaluation of VERU-111 for mCRPC in Patients Who Have Failed at Least One Androgen Receptor Targeting Agent". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04844749.
~28 spots leftby Apr 2025
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