NCT02361086

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2014

Longer than P75 for phase_1

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 11, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

February 1, 2019

Status Verified

January 1, 2019

Enrollment Period

3.5 years

First QC Date

January 29, 2015

Last Update Submit

January 31, 2019

Conditions

Castration-resistant Prostate CancerCRPC

Keywords

castration-resistant prostate cancerCYP17P450c17alyase

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

  • Time to maximum plasma concentration (Tmax) of VT-464

    After the first dose of VT-464

Other Outcomes (3)

  • The change in PSA from baseline using waterfall plots in response to VT-464

    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

    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

    At least monthly over the first 8 28-day dosing cycles

Study Arms (6)

Regimen 1: 7dayPM+DT

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.

Drug: VT-464: given orally once daily in 28 day cycles

Regimen 2: 7dayPM-DT

EXPERIMENTAL

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

Regimen 3: 7dayAM+DT

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.

Drug: VT-464: given orally once daily in 28 day cycles

Regimen 4: 7dayAM-DT

EXPERIMENTAL

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

Regimen 5: 5dayPM-DT

EXPERIMENTAL

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

Regimen 6: 5dayAM-DT

EXPERIMENTAL

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

Interventions

VT-464: given orally once daily in 28 day cyclesDRUG

VT-464: given orally once daily in 28 day cycles either 5 days or 7 days a week.

Also known as: VT-464
Regimen 1: 7dayPM+DTRegimen 2: 7dayPM-DTRegimen 3: 7dayAM+DTRegimen 4: 7dayAM-DTRegimen 5: 5dayPM-DTRegimen 6: 5dayAM-DT

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Urology Cancer Center

Omaha, Nebraska, 68130, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572, United States

Location

Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

Location

MeSH Terms

Interventions

VT-464

Study Officials

  • Joel Eisner

    Innocrin Pharmaceutical

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2015

First Posted

February 11, 2015

Study Start

June 1, 2014

Primary Completion

December 1, 2017

Study Completion

June 1, 2018

Last Updated

February 1, 2019

Record last verified: 2019-01

Locations

US(5)