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

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: NCT04843319
Recruitment Status : Active, not recruiting
First Posted : April 13, 2021
Last Update Posted : January 12, 2022
Sponsor:
Information provided by (Responsible Party):
Veru Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Advanced Prostate Adenocarcinoma Drug: VERU-100 Phase 1 Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Open label single arm
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label, Proof-of-Concept and Dose Finding Phase 1b/2 Study of VERU-100 in Men With Advanced Prostate Cancer
Actual Study Start Date : June 9, 2021
Estimated Primary Completion Date : February 28, 2022
Estimated Study Completion Date : March 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: VERU-100 at various doses
150 mg, 200 mg, 300 mg or 400 mg of VERU-100
Drug: VERU-100
GnRH antagonist




Primary Outcome Measures :
  1. Percent of men with total testosterone at <50 ng/dL by day 28 [ Time Frame: Day 28 ]
    Percent of men that reach castrate level (<50 ng/dL) of total testosterone levels by Day 28


Secondary Outcome Measures :
  1. Total testosterone below 20ng/dL levels on VERU-100 [ Time Frame: Day 28 and Day 91 ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Male
Accepts Healthy Volunteers:   No
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 QTc interval <440 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

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): NCT04843319


Locations
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United States, Arizona
Arizona Urology Specialist
Tucson, Arizona, United States, 85704
Urology Associates of Southern Arizona
Tucson, Arizona, United States, 85715
United States, Arkansas
Arkansas Urology
Little Rock, Arkansas, United States, 72211
United States, California
San Bernardino Urological Associates
San Bernardino, California, United States, 92404
United States, Indiana
First Urology, PSC
Jeffersonville, Indiana, United States, 47130
United States, Maryland
Chesapeake Urology Research Associates
Towson, Maryland, United States, 21204
United States, New York
Associated Medical Professionals of NY, PLCC
Syracuse, New York, United States, 13210
United States, North Carolina
Associated Urologists of North Carolina
Raleigh, North Carolina, United States, 27612
United States, Ohio
Clinical Research Solutions
Middleburg Heights, Ohio, United States, 44130
United States, Pennsylvania
MidLantic Urology
Bala-Cynwyd, Pennsylvania, United States, 19004
United States, South Carolina
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
United States, Texas
Houston Metro Urology
Houston, Texas, United States, 77027
Urology San Antonio
San Antonio, Texas, United States, 78229
United States, Virginia
Urology of Virginia
Virginia Beach, Virginia, United States, 23462
Sponsors and Collaborators
Veru Inc.
Investigators
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Study Chair: Bernette Veru Inc.
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Responsible Party: Veru Inc.
ClinicalTrials.gov Identifier: NCT04843319    
Other Study ID Numbers: V2010001
First Posted: April 13, 2021    Key Record Dates
Last Update Posted: January 12, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenocarcinoma
Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type