Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT03646162
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03646162
Recruitment Status : Active, not recruiting
First Posted : August 24, 2018
Last Update Posted : October 18, 2019
Sponsor:
Information provided by (Responsible Party):
Veru Inc.

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

Condition or disease Intervention/treatment Phase
Prostate Cancer Metastatic Drug: Veru-944 Drug: Placebo Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Double-blind, Placebo Controlled, Dose Finding Phase 2 Study Comparing Oral Daily Dosing of VERU-944 to Ameliorate the Vasomotor Symptoms Resulting From ADT in Men With Advanced Prostate Cancer
Actual Study Start Date : September 14, 2018
Estimated Primary Completion Date : February 29, 2020
Estimated Study Completion Date : February 29, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Veru-944 10 mg
Veru-944 10 mg daily
Drug: Veru-944
Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT
Other Name: Zuclomiphene citrate

Experimental: Veru-944 50 mg
Veru-944 50 mg daily
Drug: Veru-944
Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT
Other Name: Zuclomiphene citrate

Experimental: Veru-944 100 mg
Veru-944 100mg daily
Drug: Veru-944
Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT
Other Name: Zuclomiphene citrate

Placebo Comparator: Placebo
Placebo daily
Drug: Placebo
Placebo




Primary Outcome Measures :
  1. Change in frequency and severity of vasomotor symptoms; Hot Flashes [ Time Frame: 84 days ]
    Mean change in frequency of moderate to severe hot flashes from baseline to day 30 and baseline to day 84


Secondary Outcome Measures :
  1. Change in bone turnover markers. C-telopeptide (CTX) [ Time Frame: 84 days ]
    Change in C-telopeptide concentrations at day 84 compared with baseline

  2. Change in bone turnover markers. Bone specific alkaline phosphatase [ Time Frame: 84 days ]
    Change in bone specific alkaline phosphatase concentrations at day 84 compared with baseline


Other Outcome Measures:
  1. Change in serum PSA [ Time Frame: 84 Days ]
    Change in serum PSA concentration comparing baseline to day 30, baseline to day 60 and baseline to day 84 for each treatment group

  2. Change in Serum Total Testosterone [ Time Frame: 84 Days ]
    Change in serum total testosterone concentration comparing baseline to day 30, baseline to day 60 and baseline to day 84 for each treatment group

  3. Change in Serum Free Testosterone [ Time Frame: 84 days ]
    Change in serum free testosterone concentration comparing baseline to day 30, baseline to day 60 and baseline to day 84 for each treatment group

  4. Change in serum SHBG [ Time Frame: 84 days ]
    Change in serum SHBG concentration comparing baseline to day 30, baseline to day 60 and baseline to day 84 for each treatment group

  5. Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)sess safety [ Time Frame: 114 days ]
    Incidence of Treatment-Emergent Adverse Events will be tabulated by MedDRA terms and system organ class. The incidence of AEs and the maximum intensity and frequency of AEs will be summarized. The intensity of AE will be graded according to CTCAE version 4. Changes from baseline will be computed and tested for significant change from baseline to day 114



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Males
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03646162


  Show 24 Study Locations
Sponsors and Collaborators
Veru Inc.
Investigators
Layout table for investigator information
Study Chair: Gary Barnette Veru Inc.

Layout table for additonal information
Responsible Party: Veru Inc.
ClinicalTrials.gov Identifier: NCT03646162     History of Changes
Other Study ID Numbers: V72203
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: October 18, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Zuclomiphene
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators