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

Innocrin Pharmaceutical5 sites in 1 country21 target enrollmentJune 2014

ConditionsCastration-resistant Prostate Cancer CRPC

DrugsVT-464: given orally once daily in 28 day cycles

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Castration-resistant Prostate Cancer
Sponsor: Innocrin Pharmaceutical
Enrollment: 21
Locations: 5
Primary Endpoint: The safety and tolerability of VT-464 by evaluating adverse events, vital signs, physical examination findings, concomitant medications and laboratory tests.
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2014

End Date

June 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Innocrin Pharmaceutical

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

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)