Study of VERU-944 to Ameliorate Hot Flashes in Men With Advanced Prostate Cancer

NCT03646162 | Completed Phase 2 Results FDA Drug

• 1 other identifier: V72203
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 24

Brief Summary

Randomized, double-blind, placebo controlled, dose finding Phase 2 study comparing oral daily dosing of VERU-944 after a week of loading (daily dosing) with placebo to ameliorate the vasomotor symptoms resulting from androgen deprivation therapy in men with advanced prostate cancer

Conditions

Prostate Cancer Metastatic

Outcome Measures

Primary Outcomes (1)

• Change in Frequency of Moderate to Severe Hot Flashes at 6 Weeks

  Percentage of change in frequency of moderate to severe hot flashes at 6 weeks

  6 weeks

Secondary Outcomes (5)

• Percentage Change in Severity of Moderate to Severe Hot Flashes at 6 Weeks

  6 weeks

• Change of Frequency of Moderate to Severe Hot Flashes at Week 12

  Weeks 12

• Change in Severity of Moderate to Severe Hot Flashes at Week 12

  Week 12

• Change in Bone Turnover Markers C-telopeptide (CTX)

  84 days

• Change in Bone Turnover Markers Alkaline Phosphatase

  84 days

Other Outcomes (5)

• Change in Serum PSA

  84 Days

• Change in Serum Total Testosterone

  84 Days

• Change in Serum Free Testosterone

  84 days

Study Arms (3)

Veru-944 10 mg

EXPERIMENTAL

Veru-944 10 mg daily

Drug: Veru-944

Veru-944 50 mg

EXPERIMENTAL

Veru-944 50 mg daily

Drug: Veru-944

Placebo

PLACEBO COMPARATOR

Placebo daily

Drug: Placebo

Interventions

Veru-944 DRUG

Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT

Also known as: Zuclomiphene citrate

Veru-944 10 mg; Veru-944 50 mg

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Males
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be over 18 years of age;
• Be able to communicate effectively with the study personnel;
• Have histologically confirmed prostate cancer;
• Have been treated with an LHRH agonist or LHRH antagonist for at least the 3 months prior to randomization;
• Be continued on an LHRH agonist or LHRH antagonist throughout this study;
• Have experienced hot flashes for at least one month prior to study entry;
• Have moderate or severe vasomotor symptoms (hot flashes) (defined as a minimum of 4 moderate to severe hot flashes per day or 12 per week at baseline);
• ECOG performance status of 0 to 2
• Be willing to uses electronic data capture for the relevant medical events
• Must be at least 80% compliant during the screening period
• 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 6 months 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 azospermia), 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/film/cream/suppository \[i.e., barrier method of contraception\], surgical sterilization (vasectomy with documentation of azospermia) 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.

You may not qualify if:

• Have a serum total testosterone concentration \> 50 ng/dL at screening;
• Known hypersensitivity or allergy to estrogen or estrogen like 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;
• Subjects with a personal history of abnormal blood clotting or thrombotic disease, including venous or arterial thrombotic events such as a history of stroke, deep vein thrombosis (DVT), and/or pulmonary embolus (PE);
• Any subjects, as determined by a central laboratory, that have a:
• Factor V Leiden gene mutation
• Prothrombin gene mutation
• Uncontrolled symptomatic congestive heart failure (NYHA Class III - IV), unstable angina pectoris, cardiac arrhythmia, or uncontrolled atrial fibrillation;
• History of MI
• The presence of consistently abnormal laboratory values which are considered clinically significant. In addition, any subject with liver enzymes (ALT or AST) above 2 times the upper limit of normal, total bilirubin above 2 times the upper limit of normal, or serum creatinine above 1.5 times the upper limit of normal will NOT be admitted to the study;
• Received an investigational drug within a period of 90 days prior to enrollment in the study;
• Received the study medication (VERU-944) previously;
• Have previously taken within 6 months prior to screening or are currently taking diethylstilbestrol, other estrogens;
• Currently taking gabapentin, estrogen, diethylstilbestrol, medroxyprogesterone acetate, clomiphene, selective serotonin reuptake inhibitors (SSRIs), other treatments for hot flashes
• Recent hospitalization for more than 24 hours (within 30 days of screening);

Sponsors & Collaborators

• Veru Inc.: lead

Study Sites (24)

Gen1 Research

Glendale, Arizona, 85308, United States

Location

Tower Urology

Los Angeles, California, 90048, United States

Location

Urology of San Bernardino

San Bernardino, California, 92404, United States

Location

The Urology Center of Colorado

Denver, Colorado, 80211, United States

Location

Foothills Urology

Golden, Colorado, 80401, United States

Location

Universal Axon Clinical Research

Doral, Florida, 33166, United States

Location

Medical Research Center

Miami, Florida, 33144, United States

Location

North Idaho Urology

Coeur d'Alene, Idaho, 83814, United States

Location

First Urology

Jeffersonville, Indiana, 47130, United States

Location

Regional Urology LLC

Shreveport, Louisiana, 71101, United States

Location

Chesapeake Urology

Towson, Maryland, 21204, United States

Location

Coastal Urology

Brick, New Jersey, 08724, United States

Location

Premier Urology Group

Edison, New Jersey, 08837, United States

Location

Advance Urology

Elmont, New York, 11003, United States

Location

AccuMed Research

Garden City, New York, 11530, United States

Location

Premier Medical Group of the Hudson Valley

Poughkeepsie, New York, 12601, United States

Location

Associated Medical Professionals

Syracuse, New York, 13210, United States

Location

Clinical Research Solutions

Middleburg Heights, Ohio, 44130, United States

Location

Urologic Consultants

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

Mary Crowley Cancer Research

Dallas, Texas, 75230, United States

Location

Urology Clinics of North Texas

Dallas, Texas, 75231, United States

Location

Houston Urology Partners

Houston, Texas, 77091, United States

Location

Urology San Antonio

San Antonio, Texas, 78229, United States

Location

Urology of Virginia

Virginia Beach, Virginia, 23462, United States

Location

MeSH Terms

Interventions

Zuclomiphene

Intervention Hierarchy (Ancestors)

Clomiphene; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Gary Barnette PhD CSO
• Organization: Veru

gbarnette@verupharma.com

9194263611

Study Officials

• Barnette

  Veru Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2018
• First Posted: August 24, 2018
• Study Start: September 14, 2018
• Primary Completion: April 30, 2020
• Study Completion: October 15, 2020
• Last Updated: December 3, 2021
• Results First Posted: June 18, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (24)