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Advanced Prostate AdenocarcinomaPhase 1/2VERU-100NCT04843319

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

A Phase 1/2 study testing VERU-100 in people with Advanced Prostate Adenocarcinoma, run by Veru Inc. at 11 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 100 years, men only
Conditions the study is for
Advanced Prostate Adenocarcinoma
What is being tested?
VERU-100
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
11 sitesUnited States
Study dates
9 Jun 2021to 19 Jan 2023
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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
  • 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.
  • 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).
  • 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.
  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

United States11 sites

  • MidLantic Urology

    Bala-Cynwyd, Pennsylvania, 19004

  • Houston Metro Urology

    Houston, Texas, 77027

  • Debbie Urology Johnson

    Jeffersonville, Indiana, 47130

  • Clinical Research Solutions

    Middleburg Heights, Ohio, 44130

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572

  • Urology San Antonio

    San Antonio, Texas, 78229

  • San Bernardino Urological Associates

    San Bernardino, California, 92404

  • Genesis Research, LLC

    San Diego, California, 92123

  • Chesapeake Urology Research Associates

    Towson, Maryland, 21204

  • Arizona Urology Specialist

    Tucson, Arizona, 85704

  • Urology Associates of Southern Arizona

    Tucson, Arizona, 85715

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
VERU-100

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VERU-100Drug

    GnRH antagonist

Study groups in NCT04843319
Study groupRoleWhat they receive
VERU-100 at various dosesExperimental2 ml, 2.5 ml, 3 ml, 3.5 ml of VERU-100
Receives: Drug: VERU-100

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent of men with total testosterone at <50 ng/dL by day 28

    Percent of men that reach castrate level (<50 ng/dL) of total testosterone levels by Day 28

    Measured: Day 28

Secondary outcomes (1)

  1. Total testosterone below 20ng/dL levels on VERU-100

    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

    Measured: Day 28 and Day 91

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2021
  2. Study start9 Jun 2021
  3. Primary completion19 Jan 2023
  4. Study completion19 Jan 2023

Why it stopped: Study terminated as end points were not achieved at current dose level.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Open label single arm
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04843319
Sponsor's protocol ID
V2010001
Acronym
VERU-100
Status last verified
May 2023
First submitted
9 Apr 2021
Last updated
19 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing VERU-100 in people with Advanced Prostate Adenocarcinoma, run by Veru Inc. at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Study terminated as end points were not achieved at current dose level.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent of men with total testosterone at <50 ng/dL by day 28 (time frame: Day 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04843319.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2023.

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