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

NCT ID: NCT03646162

Last Updated: 2021-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 93 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-14
• Study Completion Date: 2020-10-15

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

Detailed Description

This study is a multicenter, randomized, double-blind, placebo controlled, dose finding study of VERU-944 to treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT. The study will have four arms with 30 subjects per arm. The subjects participating in the study will have advanced prostate cancer and will be undergoing androgen deprivation therapy (ADT) with a luteinizing hormone releasing hormone (LHRH) therapy (agonist or antagonist) for at least the three months prior to randomization and be experiencing regular moderate to severe hot flashes while on ADT. Subjects will all continue to receive ADT and will be randomized to receive, for the first four days, a loading dose followed by daily doses of placebo or VERU-944 (10 mg, 50 mg or 100 mg) orally for a total period of 12 weeks.

Conditions

Prostate Cancer Metastatic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Veru-944 10 mg

Veru-944 10 mg daily

Group Type: EXPERIMENTAL

Veru-944

Intervention Type: DRUG

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

Veru-944 50 mg

Veru-944 50 mg daily

Group Type: EXPERIMENTAL

Veru-944

Intervention Type: DRUG

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

Placebo

Placebo daily

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

Veru-944

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

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Other Intervention Names

Zuclomiphene citrate

Eligibility Criteria

Inclusion Criteria

1. Be over 18 years of age;

2. Be able to communicate effectively with the study personnel;

3. Have histologically confirmed prostate cancer;

4. Have been treated with an LHRH agonist or LHRH antagonist for at least the 3 months prior to randomization;

5. Be continued on an LHRH agonist or LHRH antagonist throughout this study;

6. Have experienced hot flashes for at least one month prior to study entry;

7. 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);

8. ECOG performance status of 0 to 2

9. Be willing to uses electronic data capture for the relevant medical events

• Must be at least 80% compliant during the screening period

10. 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.

11. Subject is willing to comply with the requirements of the protocol through the end of the study.

Exclusion Criteria

1. Have a serum total testosterone concentration > 50 ng/dL at screening;

2. Known hypersensitivity or allergy to estrogen or estrogen like drugs;

3. 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;

4. 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);

5. Any subjects, as determined by a central laboratory, that have a:

• Factor V Leiden gene mutation
• Prothrombin gene mutation

6. Uncontrolled symptomatic congestive heart failure (NYHA Class III - IV), unstable angina pectoris, cardiac arrhythmia, or uncontrolled atrial fibrillation;

7. History of MI

8. 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;

9. Received an investigational drug within a period of 90 days prior to enrollment in the study;

10. Received the study medication (VERU-944) previously;

11. Have previously taken within 6 months prior to screening or are currently taking diethylstilbestrol, other estrogens;

12. Currently taking gabapentin, estrogen, diethylstilbestrol, medroxyprogesterone acetate, clomiphene, selective serotonin reuptake inhibitors (SSRIs), other treatments for hot flashes

13. Recent hospitalization for more than 24 hours (within 30 days of screening);

14. Recent surgery (within 30 days of screening);

15. Have been previously diagnosed or treated for active cancer (other than prostate cancer or non-melanoma skin cancer) within the previous five years;

16. Have a BMI >40.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Veru Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Barnette

Role: STUDY_CHAIR

Veru Inc.

Locations

Gen1 Research

Glendale, Arizona, United States

Tower Urology

Los Angeles, California, United States

Urology of San Bernardino

San Bernardino, California, United States

The Urology Center of Colorado

Denver, Colorado, United States

Foothills Urology

Golden, Colorado, United States

Universal Axon Clinical Research

Doral, Florida, United States

Medical Research Center

Miami, Florida, United States

North Idaho Urology

Coeur d'Alene, Idaho, United States

First Urology

Jeffersonville, Indiana, United States

Regional Urology LLC

Shreveport, Louisiana, United States

Chesapeake Urology

Towson, Maryland, United States

Coastal Urology

Brick, New Jersey, United States

Premier Urology Group

Edison, New Jersey, United States

Advance Urology

Elmont, New York, United States

AccuMed Research

Garden City, New York, United States

Premier Medical Group of the Hudson Valley

Poughkeepsie, New York, United States

Associated Medical Professionals

Syracuse, New York, United States

Clinical Research Solutions

Middleburg Heights, Ohio, United States

Urologic Consultants

Bala-Cynwyd, Pennsylvania, United States

Mary Crowley Cancer Research

Dallas, Texas, United States

Urology Clinics of North Texas

Dallas, Texas, United States

Houston Urology Partners

Houston, Texas, United States

Urology San Antonio

San Antonio, Texas, United States

Urology of Virginia

Virginia Beach, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

V72203

Identifier Type: -

Identifier Source: org_study_id