Trials / Terminated
TerminatedNCT04843319
To Determine an Effective Dose of VERU-100 for the Treatment of Advanced Prostate Cancer
Open-Label, Proof-of-Concept and Dose Finding Phase 1b/2 Study of VERU-100 in Men With Advanced Prostate Cancer
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Veru Inc. · Industry
- Sex
- Male
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | VERU-100 | GnRH antagonist |
Timeline
- Start date
- 2021-06-09
- Primary completion
- 2023-01-19
- Completion
- 2023-01-19
- First posted
- 2021-04-13
- Last updated
- 2023-05-19
Locations
11 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04843319. Inclusion in this directory is not an endorsement.