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

Open-Label, Proof-of-Concept and Dose Finding Phase 1b/2 Study of VERU-100 in Men With Advanced Prostate Cancer

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.

Study Overview

• Status: Terminated
• Conditions: Advanced Prostate Adenocarcinoma
• Intervention / Treatment: Drug: VERU-100

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Barnette, MD; Phone Number: 800-606-9382; Email: veruclinicaltrials@verupharma.com
• Study Contact Backup: Name: Rodriguez; Phone Number: 18006069382; Email: veruclinicaltrials@verupharma.com

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85704
      • Arizona Urology Specialist
    • Tucson, Arizona, United States, 85715
      • Urology Associates of Southern Arizona
  • California
    • San Bernardino, California, United States, 92404
      • San Bernardino Urological Associates
    • San Diego, California, United States, 92123
      • Genesis Research, LLC
  • Indiana
    • Jeffersonville, Indiana, United States, 47130
      • Debbie Urology Johnson
  • Maryland
    • Towson, Maryland, United States, 21204
      • Chesapeake Urology Research Associates
  • Ohio
    • Middleburg Heights, Ohio, United States, 44130
      • Clinical Research Solutions
  • Pennsylvania
    • Bala-Cynwyd, Pennsylvania, United States, 19004
      • MidLantic Urology
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29572
      • Carolina Urologic Research Center
  • Texas
    • Houston, Texas, United States, 77027
      • Houston Metro Urology
    • San Antonio, Texas, United States, 78229
      • Urology San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VERU-100 at various doses; 2 ml, 2.5 ml, 3 ml, 3.5 ml of VERU-100	Drug: VERU-100; GnRH antagonist

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Veru Inc.
• Investigators: Study Chair: Bernette, Veru Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2021
• Primary Completion (Actual): January 19, 2023
• Study Completion (Actual): January 19, 2023

Study Registration Dates

• First Submitted: April 9, 2021
• First Submitted That Met QC Criteria: April 9, 2021
• First Posted (Actual): April 13, 2021

Study Record Updates

• Last Update Posted (Actual): May 19, 2023
• Last Update Submitted That Met QC Criteria: May 17, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma
• Other Study ID Numbers: V2010001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No