To Determine an Effective Dose of VERU-100 for the Treatment of Advanced Prostate Cancer
(VERU-100 Trial)
Recruiting in Palo Alto (17 mi)
+19 other locations
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Waitlist Available
Sponsor: Veru Inc.
No Placebo Group
Trial Summary
What is the purpose of this trial?
This trial is testing VERU-100, a new drug, to see if it can lower and maintain low testosterone levels in men with advanced prostate cancer. By reducing testosterone, the drug aims to control the progression of the cancer.
Eligibility Criteria
Inclusion Criteria
Be over 18 years of age
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
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Exclusion Criteria
History of Torsade de Pointes
Currently taking QT-prolonging drugs
Use of exogenous testosterone within 6 months of Screening Visit
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Treatment Details
Interventions
- VERU-100 (Anti-androgen)
Participant Groups
1Treatment groups
Experimental Treatment
Group I: VERU-100 at various dosesExperimental Treatment1 Intervention
2 ml, 2.5 ml, 3 ml, 3.5 ml of VERU-100
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Foothills Urology, PCGolden, CO
Arizona Urology Specialists, PLLCGlendale, AZ
Genesis Research, LLCSan Diego, CA
San Bernardino Urological AssociatesSan Bernardino, CA
More Trial Locations
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Who Is Running the Clinical Trial?
Veru Inc.Lead Sponsor