Overview

This trial is active, not recruiting.

Conditions castration-resistant prostate cancer, crpc
Treatment vt-464: given orally once daily in 28 day cycles
Phase phase 1/phase 2
Sponsor Innocrin Pharmaceutical
Start date June 2014
End date December 2016
Trial size 21 participants
Trial identifier NCT02361086, INO-VT-464-CL-004

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
VT-464: given orally once daily in 28 day cycles. Dosing in the evening before bed 7-days a week with a 2-week dose titration.
vt-464: given orally once daily in 28 day cycles VT-464
VT-464: given orally once daily in 28 day cycles either 5 days or 7 days a week.
(Experimental)
VT-464: given orally once daily in 28 day cycles. Dosing in the evening before bed 7-days a week without dose titration.
vt-464: given orally once daily in 28 day cycles VT-464
VT-464: given orally once daily in 28 day cycles either 5 days or 7 days a week.
(Experimental)
VT-464: given orally once daily in 28 day cycles. Dosing in the morning 7-days a week with a 2-week dose titration.
vt-464: given orally once daily in 28 day cycles VT-464
VT-464: given orally once daily in 28 day cycles either 5 days or 7 days a week.
(Experimental)
VT-464: given orally once daily in 28 day cycles.Dosing in the morning 7-days a week without dose titration.
vt-464: given orally once daily in 28 day cycles VT-464
VT-464: given orally once daily in 28 day cycles either 5 days or 7 days a week.
(Experimental)
VT-464: given orally once daily in 28 day cycles.Dosing in the evening before bed 5-days a week without dose titration.
vt-464: given orally once daily in 28 day cycles VT-464
VT-464: given orally once daily in 28 day cycles either 5 days or 7 days a week.
(Experimental)
VT-464: given orally once daily in 28 day cycles.Dosing in the morning 5-days a week without dose titration.
vt-464: given orally once daily in 28 day cycles VT-464
VT-464: given orally once daily in 28 day cycles either 5 days or 7 days a week.

Primary Outcomes

Measure
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

Measure
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

Eligibility Criteria

Male participants at least 18 years old.

Key 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 1. Key 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.

Additional Information

Official title 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
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Innocrin Pharmaceutical.
Location data was received from the National Cancer Institute and was last updated in September 2016.