To Determine an Effective Dose of VERU-100 for the Treatment of Advanced Prostate Cancer (VERU-100)

May 17, 2023 updated by: Veru Inc.

Open-Label, Proof-of-Concept and Dose Finding Phase 1b/2 Study of VERU-100 in Men With Advanced Prostate Cancer

To determine an effective dose of VERU-100 for the treatment of advanced prostate cancer by assessing its effect on testosterone levels by Day 28 and maintenance through Day 91.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is a multicenter, randomized, open-label, dose finding study of VERU-100 to attain and maintain serum total testosterone levels within castrate range (<50ng/dL) in men with advanced prostate cancer. Stage 1 of the study will assess the effect of VERU-100 at various doses. Stage 2 will further assess the efficacy of the effective doses of VERU-100 in an expanded patient population.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85704
        • Arizona Urology Specialist
      • Tucson, Arizona, United States, 85715
        • Urology Associates of Southern Arizona
    • California
      • San Bernardino, California, United States, 92404
        • San Bernardino Urological Associates
      • San Diego, California, United States, 92123
        • Genesis Research, LLC
    • Indiana
      • Jeffersonville, Indiana, United States, 47130
        • Debbie Urology Johnson
    • Maryland
      • Towson, Maryland, United States, 21204
        • Chesapeake Urology Research Associates
    • Ohio
      • Middleburg Heights, Ohio, United States, 44130
        • Clinical Research Solutions
    • Pennsylvania
      • Bala-Cynwyd, Pennsylvania, United States, 19004
        • MidLantic Urology
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Carolina Urologic Research Center
    • Texas
      • Houston, Texas, United States, 77027
        • Houston Metro Urology
      • San Antonio, Texas, United States, 78229
        • Urology San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Be over 18 years of age
  • Be able to communicate effectively with the study personnel
  • Have histologically confirmed prostate cancer
  • Have prostate cancer staged T3-4NxMx or TxN1Mx or TxNxM1 according to the TNM classification or the patient should have rising PSA after failed local therapy and be candidate for androgen deprivation therapy
  • Have a QTc interval <440 ms
  • Subjects are judged by the attending physician and/or Principal Investigator to be a candidate for androgen deprivation therapy (continuous therapy)
  • ECOG performance status of 0 to 2
  • Baseline morning serum testosterone levels >150 ng/dL at Screening Visit
  • Have a life expectancy of ≥18 months

  • Subjects must agree to use acceptable methods of contraception

    1. If their female partners are pregnant or lactating, acceptable methods of contraception from the time of the first administration of study medication until 6months following administration of the last dose of study medication must be used. Acceptable methods are: Condom used with spermicidal foam/gel/film/cream/suppository. If the subject has undergone surgical sterilization (vasectomy with documentation of azoospermia),a condom with spermicidal foam/gel/film/cream/suppository should be used.
    2. If the male subject's partner could become pregnant, use acceptable methods of contraception from the time of the first administration of study medication until 6 months following administration of the last dose of study medication. Acceptable methods of contraception are as follows: Condom with spermicidal foam/gel/cream/suppository [i.e.,barrier method of contraception], surgical sterilization (vasectomy with documentation of azoospermia) and a barrier method {condom used with spermicidal foam/gel/film/cream/suppository}, the female partner uses oral contraceptives (combination estrogen/progesterone pills), injectable progesterone or subdermal implants and a barrier method (condom used with spermicidal foam/gel/film/cream/suppository).
    3. If the female partner has undergone documented tubal ligation (female sterilization), a barrier method (condom used with spermicidal foam/gel/film/cream/suppository) should also be used.
    4. If the female partner has undergone documented placement of an intrauterine device (IUD) or intrauterine system (IUS),a barrier method (condom with spermicidal foam/gel/film/cream/suppository) should also be used.

  • Laboratory values within the following ranges: hemoglobin ≥10 gm/dL, total bilirubin

    • 1.5x upper limit of normal (ULN), AST ≤2.5x ULN, ALT ≤2.5x ULN,
    • 1.5 mg/dL, absolute neutrophil count ≥1500 cell/uL and platelets ≥100,000 cells/uL.
  • Creatinine clearance ≥60 mL/min based on Cockcroft-Gault equation.
  • Subject is willing to comply with the requirements of the protocol through the end of the study

Exclusion Criteria:

  • Prior androgen deprivation therapy within 6 months prior to Screening Visit.
  • Potentially curable disease receiving ADT for localized disease
  • History of bilateral orchiectomy, adrenalectomy, or hypophysectomy
  • Received chemotherapy, cryotherapy, or antiandrogen therapy within 8 weeks prior to the Screening visit for the treatment of prostate cancer.
  • Known hypersensitivity to cetrorelix or other LHRH antagonists
  • History of Torsade de Pointes
  • Currently taking QT-prolonging drugs
  • Any disease or condition (medical or surgical) which might compromise the hematologic, cardiovascular, endocrine, pulmonary, renal, gastrointestinal, hepatic, or central nervous system; or other conditions that may interfere with the absorption, distribution, metabolism or excretion of study drug, or would place the subject at increased risk
  • Use of exogenous testosterone within 6 months of Screening Visit
  • Use of 5α-reductase inhibitor within 3 months of Screening Visit
  • Use of systemic corticosteroids at a dose >10 mg/day at Screening
  • Major surgery within 4 weeks of Screening Visit (including surgery for prostate cancer)
  • Uncontrolled symptomatic congestive heart failure (NYHA Class III -IV), unstable angina pectoris, cardiac arrhythmia, or uncontrolled atrial fibrillation
  • History of diabetes mellitus Type 1. Uncontrolled diabetes mellitus Type 2 (control with oral hypoglycemic agents are allowed)
  • Received an investigational drug within a period of 90days prior to enrollment in the study
  • Received the study medication (VERU-100) previously
  • Have been previously diagnosed or treated for active cancer(other than prostate cancer or non-melanoma skin cancer) within the previous five years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: VERU-100 at various doses
2 ml, 2.5 ml, 3 ml, 3.5 ml of VERU-100
Drug: VERU-100
GnRH antagonist

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percent of men with total testosterone at <50 ng/dL by day 28
Time Frame: Day 28
Percent of men that reach castrate level (<50 ng/dL) of total testosterone levels by Day 28
Day 28

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Total testosterone below 20ng/dL levels on VERU-100
Time Frame: Day 28 and Day 91
Percent of men that reach <20 ng/dL of total testosterone levels by Day 28 that are maintained at <20 ng/dL through Day 91
Day 28 and Day 91

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Veru Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Bernette, Veru Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 9, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 19, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 19, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 9, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 19, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • V2010001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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