Clinical Trials /

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

NCT04843319

Description:

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.

Related Conditions:
  • Prostate Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: To Determine an Effective Dose of VERU-100 for the Treatment of Advanced Prostate Cancer
  • Official Title: Open-Label, Proof-of-Concept and Dose Finding Phase 1b/2 Study of VERU-100 in Men With Advanced Prostate Cancer

Clinical Trial IDs

  • ORG STUDY ID: V2010001
  • NCT ID: NCT04843319

Conditions

  • Advanced Prostate Adenocarcinoma

Interventions

DrugSynonymsArms
VERU-100150 mg dose of VERU-100

Purpose

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.

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 150 mg of VERU-100.
      Stage 2 will further assess the efficacy of the effective doses of VERU-100 in an expanded
      patient population.
    

Trial Arms

NameTypeDescriptionInterventions
150 mg dose of VERU-100Experimental150mg of VERU-100
  • VERU-100

Eligibility Criteria

        Inclusion Criteria:

          -  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 QT interval <400 ms

          -  Subjects are judged by the attending physician and/or Principal Investigator to be a
             candidate for androgen deprivation therapy (continuous therapy)

          -  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

               1. 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.

               2. 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).

               3. 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.

               4. 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

        Exclusion Criteria:

          -  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

          -  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
      
Maximum Eligible Age:100 Years
Minimum Eligible Age:18 Years
Eligible Gender:Male
Healthy Volunteers:No

Primary Outcome Measures

Measure:Percent of men with total testosterone at <50 ng/dL by day 28
Time Frame:Day 28
Safety Issue:
Description:Percent of men that reach castrate level (<50 ng/dL) of total testosterone levels by Day 28

Secondary Outcome Measures

Measure:Total testosterone below 20ng/dL levels on VERU-100
Time Frame:Day 28 and Day 91
Safety Issue:
Description: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

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Veru Inc.

Last Updated

August 30, 2021