A Study to Evaluate Once-Daily Oral VT-464 in Patients With Castration-Resistant Prostate Cancer

January 31, 2019 updated by: Innocrin Pharmaceutical

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center and Research Institute
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Urology Cancer Center
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Carolina Urologic Research Center
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Virginia Oncology Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Regimen 1: 7dayPM+DT
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.
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.
Other Names:
  • VT-464
Experimental: Regimen 2: 7dayPM-DT
VT-464: given orally once daily in 28 day cycles. Dosing in the evening before bed 7-days a week without dose titration.
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.
Other Names:
  • VT-464
Experimental: Regimen 3: 7dayAM+DT
VT-464: given orally once daily in 28 day cycles. Dosing in the morning 7-days a week with a 2-week dose titration.
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.
Other Names:
  • VT-464
Experimental: Regimen 4: 7dayAM-DT
VT-464: given orally once daily in 28 day cycles.Dosing in the morning 7-days a week without dose titration.
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.
Other Names:
  • VT-464
Experimental: Regimen 5: 5dayPM-DT
VT-464: given orally once daily in 28 day cycles.Dosing in the evening before bed 5-days a week without dose titration.
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.
Other Names:
  • VT-464
Experimental: Regimen 6: 5dayAM-DT
VT-464: given orally once daily in 28 day cycles.Dosing in the morning 5-days a week without dose titration.
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.
Other Names:
  • VT-464

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
The first 28-day continuous dosing cycle at target dose.

Secondary Outcome Measures

Outcome Measure
Time Frame
Peak Plasma Concentration (Cmax) of VT-464
Time Frame: After the first dose of VT-464
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
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
After the first dose of VT-464

Other Outcome Measures

Outcome Measure
Time Frame
The change in PSA from baseline using waterfall plots in response to VT-464
Time Frame: At least monthly over the first 8 28-day dosing cycles
At least monthly over the first 8 28-day dosing cycles
Objective tumor response to VT-464 at the end of even-numbered cycles using RECIST 1.1 criteria
Time Frame: At least every other month over the first 8 28-day dosing cycles
At least every other month over the first 8 28-day dosing cycles
The absolute and percent change from baseline in adrenal, pituitary, and testicular hormone concentrations in response to VT-464
Time Frame: At least monthly over the first 8 28-day dosing cycles
At least monthly over the first 8 28-day dosing cycles

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Innocrin Pharmaceutical

Investigators

  • Study Director: Joel Eisner, Innocrin Pharmaceutical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

January 29, 2015

First Submitted That Met QC Criteria

February 6, 2015

First Posted (Estimate)

February 11, 2015

Study Record Updates

Last Update Posted (Actual)

February 1, 2019

Last Update Submitted That Met QC Criteria

January 31, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INO-VT-464-CL-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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