Trials / Completed
CompletedNCT02361086
A Study to Evaluate Once-Daily Oral VT-464 in Patients With Castration-Resistant Prostate Cancer
A Phase 1/2 Open-Label, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Once-Daily VT-464 in Patients With Castration-Resistant Prostate Cancer
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 21 (actual)
- Sponsor
- Innocrin Pharmaceutical · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The goal of this clinical study is to determine the safety, tolerability, pharmacokinetics and activity of once-daily (QD) oral dosing of VT-464, a lyase-selective inhibitor of CYP17, in patients with castration-resistant prostate cancer (CRPC).
Detailed description
This is a Phase 1/2 study of VT-464 in chemotherapy-naïve CRPC patients who are treatment-naive or who have failed prior therapy with abiraterone and/or enzalutamide. The study will examine several parallel QD dosing regimens of VT-464 using a traditional modified "3+3" Fibonacci study design. Approximately 3 dose-levels of VT-464 will be examined in each dosing regimen that is fully enrolled.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | VT-464: given orally once daily in 28 day cycles | VT-464: given orally once daily in 28 day cycles either 5 days or 7 days a week. |
Timeline
- Start date
- 2014-06-01
- Primary completion
- 2017-12-01
- Completion
- 2018-06-01
- First posted
- 2015-02-11
- Last updated
- 2019-02-01
Locations
5 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02361086. Inclusion in this directory is not an endorsement.