A Study to Evaluate Once-Daily Oral VT-464 in Patients With Castration-Resistant Prostate Cancer
- Conditions
- Castration-resistant Prostate CancerCRPC
- Registration Number
- NCT02361086
- Lead Sponsor
- Innocrin Pharmaceutical
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 21
- Patients must have documented histological or cytological evidence of adenocarcinoma of the prostate.
- Patients must have a minimum serum PSA level of >2 ng/ml that is rising based on the Prostate Cancer Working Group 2 criteria.
- Patients must have castrate levels of testosterone (<50 ng/dl [1.74 nmol/l]).
- Patients must have undergone orchiectomy, or have been on LHRH agonists or antagonists, for at least 3 months prior to study entry. Patients on LHRH agonists/antagonists must remain on these agents for the duration of the study.
- Patients must have an ECOG Performance Score of 0 or 1.
Key
- Patients who have received prior cytotoxic chemotherapy for castration-resistant prostate cancer unless enrolled in a previous chemotherapy cohort.
- Patients who have received second-line antihormonal therapy, including ketoconazole, aminoglutethimide, or high-dose estrogen within 30 days of study entry.
- Patients who have completed sipuleucel-T (Provenge ®) treatment within 30 days of study entry.
- Patients who have received TOK-001 (Galeterone®) or any other investigational product directed towards the androgen receptor or androgen biosynthesis.
- Patients who have received antiandrogens such as flutamide (EULEXIN®), bicalutamide (CASODEX®), or nilutamide (NILANDRON®) for > 3 months must be off treatment for 6 weeks and demonstrate a continued rise in PSA after withdrawal. Patients on antiandrogens for < 3 months must be off medication for 2 weeks. Patients on 5 alpha reductase inhibitors such as finasteride (PROSCAR®, PROPECIA®), or dutasteride (AVODART®) must stop medication at least 3 months from study entry.
- Patients who require pharmacological or replacement doses of systemic corticosteroids or who have received systemic corticosteroids within 30 days of study entry; use of topical, inhaled or ophthalmic steroids is permitted.
- Patients who have received palliative radiotherapy within 4 weeks of study entry.
- Patients with a history within the last 3 years of another invasive malignancy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The safety and tolerability of VT-464 by evaluating adverse events, vital signs, physical examination findings, concomitant medications and laboratory tests. The first 28-day continuous dosing cycle at target dose.
- Secondary Outcome Measures
Name Time Method Time to maximum plasma concentration (Tmax) of VT-464 After the first dose of VT-464 Peak Plasma Concentration (Cmax) of VT-464 After the first dose of VT-464 Area under the plasma concentration versus time curve (AUC) of VT-464 After the first dose of VT-464
Trial Locations
- Locations (5)
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States
Urology Cancer Center
🇺🇸Omaha, Nebraska, United States
Carolina Urologic Research Center
🇺🇸Myrtle Beach, South Carolina, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Virginia Oncology Associates
🇺🇸Norfolk, Virginia, United States