Study of VERU-944 to Ameliorate Hot Flashes in Men With Advanced Prostate Cancer
Condition: Prostate Cancer Metastatic
MeSH terms: Prostatic Neoplasms
Intervention: Veru-944; Placebo
Intervention description: Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT; Placebo
Intervention MeSH terms: Zuclomiphene
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 93.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

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
    

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.