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

NCT04843319 | Terminated Phase 1 FDA Drug

• 1 other identifier: V2010001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 11

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.

Conditions

Advanced Prostate Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Total testosterone below 20ng/dL levels on VERU-100

  Day 28 and Day 91

Study Arms (1)

VERU-100 at various doses

EXPERIMENTAL

2 ml, 2.5 ml, 3 ml, 3.5 ml of VERU-100

Drug: VERU-100

Interventions

VERU-100 DRUG

GnRH antagonist

VERU-100 at various doses

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: Male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.
• 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).
• 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.
• Laboratory values within the following ranges: hemoglobin ≥10 gm/dL, total bilirubin

You may not qualify if:

• 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

Sponsors & Collaborators

• Veru Inc.: lead

Study Sites (11)

Arizona Urology Specialist

Tucson, Arizona, 85704, United States

Location

Urology Associates of Southern Arizona

Tucson, Arizona, 85715, United States

Location

San Bernardino Urological Associates

San Bernardino, California, 92404, United States

Location

Genesis Research, LLC

San Diego, California, 92123, United States

Location

Debbie Urology Johnson

Jeffersonville, Indiana, 47130, United States

Location

Chesapeake Urology Research Associates

Towson, Maryland, 21204, United States

Location

Clinical Research Solutions

Middleburg Heights, Ohio, 44130, United States

Location

MidLantic Urology

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572, United States

Location

Houston Metro Urology

Houston, Texas, 77027, United States

Location

Urology San Antonio

San Antonio, Texas, 78229, United States

Location

Study Officials

• Bernette

  Veru Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label single arm

Study Record Dates

• First Submitted: April 9, 2021
• First Posted: April 13, 2021
• Study Start: June 9, 2021
• Primary Completion: January 19, 2023
• Study Completion: January 19, 2023
• Last Updated: May 19, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)