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Tubulin Inhibitor
Efficacy Evaluation of VERU-111 for mCRPC in Patients Who Have Failed at Least One Androgen Receptor Targeting Agent (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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 360 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~360 days
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 • NCT0484274710%
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your doctor thinks it's appropriate to try a different medication that targets the androgen receptor.You have not had any other type of cancer, except for treated skin cancer or curatively treated cancer over 3 years ago.
Research Study Groups:
This trial has the following groups:- Group 1: Either VERU-111 32mg or 26mg dose will be supplied as capsules 1 orally once a day
- Group 2: Active control alternative androgen receptor targeting agent
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.