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).
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
21
VT-464: given orally once daily in 28 day cycles either 5 days or 7 days a week.
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Urology Cancer Center
Omaha, Nebraska, United States
Duke University Medical Center
Durham, North Carolina, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
The safety and tolerability of VT-464 by evaluating adverse events, vital signs, physical examination findings, concomitant medications and laboratory tests.
Time frame: The first 28-day continuous dosing cycle at target dose.
Peak Plasma Concentration (Cmax) of VT-464
Time frame: After the first dose of VT-464
Area under the plasma concentration versus time curve (AUC) of VT-464
Time frame: After the first dose of VT-464
Time to maximum plasma concentration (Tmax) of VT-464
Time frame: After the first dose of VT-464
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Virginia Oncology Associates
Norfolk, Virginia, United States