Prostate Cancer Clinical Trial

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

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.

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Full 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>

View Eligibility Criteria

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 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

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 is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

40

Study ID:

NCT04843319

Recruitment Status:

Recruiting

Sponsor:

Veru Inc.

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There are 17 Locations for this study

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Arizona Urology Specialists - Glendale- Arrowhead
Glendale Arizona, 85306, United States
Arizona Urology Specialist
Tucson Arizona, 85704, United States More Info
Andrea Navarrette
Contact
520-784-7019
[email protected]
Kalpesh Patel
Principal Investigator
Urology Associates of Southern Arizona
Tucson Arizona, 85715, United States More Info
Christina S Montijo
Contact
520-351-5582
[email protected]
Susan Kalota
Principal Investigator
Arkansas Urology
Little Rock Arkansas, 72211, United States More Info
Katie O'Brien
Contact
501-219-8900
[email protected]
Jeff Marotte
Principal Investigator
San Bernardino Urological Associates
San Bernardino California, 92404, United States More Info
Roxie Miller
Contact
909-882-2973
[email protected]
Franklin Chu
Principal Investigator
Genesis Research, LLC
San Diego California, 92123, United States More Info
Katayune Golshan
Contact
858-429-7050
[email protected]
Paul Dato
Principal Investigator
Colorado Urology
Golden Colorado, 80401, United States
Debbie Urology Johnson
Jeffersonville Indiana, 47130, United States More Info
Debbie Johnson
Contact
812-206-8161
[email protected]
James Bailen
Principal Investigator
Chesapeake Urology Research Associates
Towson Maryland, 21204, United States More Info
Heather Thomas
Contact
443-738-8188
[email protected]
Diana R Shmul
Contact
443-231-1678
[email protected]
Ronald Tutrone
Principal Investigator
Associated Medical Professionals of NY, PLCC
Syracuse New York, 13210, United States
Associated Urologists of North Carolina
Raleigh North Carolina, 27612, United States
Clinical Research Solutions
Middleburg Heights Ohio, 44130, United States More Info
Jennifer Simpkins
Contact
440-340-9010
[email protected]
Lawrence Gervasi
Principal Investigator
MidLantic Urology
Bala-Cynwyd Pennsylvania, 19004, United States More Info
Brittny Goodell
Contact
610-667-0458
[email protected]
Cheryl M Zinar
Contact
6106670458
[email protected]
Laurence Belkoff
Principal Investigator
Carolina Urologic Research Center
Myrtle Beach South Carolina, 29572, United States More Info
Taylor Stephenson
Contact
843-449-1010
[email protected]
Neal Shore
Principal Investigator
Houston Metro Urology
Houston Texas, 77027, United States More Info
Lena Ellis
Contact
713-634-4405
[email protected]
Zvi M Schiffman
Principal Investigator
Urology San Antonio
San Antonio Texas, 78229, United States More Info
Sandra Salas
Contact
210-617-4116
[email protected]
Daniel Saltzstein
Principal Investigator
Urology of Virginia
Virginia Beach Virginia, 23462, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

40

Study ID:

NCT04843319

Recruitment Status:

Recruiting

Sponsor:


Veru Inc.

How clear is this clinincal trial information?

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