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

Advanced Prostate Adenocarcinoma Clinical Trial

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

Status Terminated

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04843319
Study type	Interventional
Source	Veru Inc.
Contact
Status	Terminated
Phase	Phase 1/Phase 2
Start date	June 9, 2021
Completion date	January 19, 2023

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See also
Status	Clinical Trial	Phase
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Completed	`NCT00502164` - Study to Assess Safety and Tolerability of AZD2171 After Multiple Doses in Patients With Advanced Prostate Cancer	Phase 1
Completed	`NCT04914195` - Leuprolide Acetate 3.75 mg Depot Injection for Patients With Advanced Prostate Cancer	Phase 3