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

Primary Purpose

Castration-resistant Prostate Cancer, CRPC

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Castration-resistant Prostate Cancer focused on measuring castration-resistant prostate cancer, CYP17, P450c17a, lyase

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

H. Lee Moffitt Cancer Center and Research Institute
Urology Cancer Center
Duke University Medical Center
Carolina Urologic Research Center
Virginia Oncology Associates

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Arm Label

Regimen 1: 7dayPM+DT

Regimen 2: 7dayPM-DT

Regimen 3: 7dayAM+DT

Regimen 4: 7dayAM-DT

Regimen 5: 5dayPM-DT

Regimen 6: 5dayAM-DT

Arm Description

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. Dosing in the evening before bed 7-days a week without dose titration.

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.Dosing in the morning 7-days a week without dose titration.

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.Dosing in the morning 5-days a week without dose titration.

Outcomes

Primary Outcome Measures

The safety and tolerability of VT-464 by evaluating adverse events, vital signs, physical examination findings, concomitant medications and laboratory tests.

Secondary Outcome Measures

Peak Plasma Concentration (Cmax) of VT-464

Area under the plasma concentration versus time curve (AUC) of VT-464

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

Full Information

NCT ID

NCT02361086

First Posted

January 29, 2015

Last Updated

January 31, 2019

Sponsor

Innocrin Pharmaceutical

1. Study Identification

Unique Protocol Identification Number

NCT02361086

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

June 2014 (undefined)

Primary Completion Date

December 2017 (Actual)

Study Completion Date

June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Innocrin Pharmaceutical

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Castration-resistant Prostate Cancer, CRPC

Keywords

castration-resistant prostate cancer, CYP17, P450c17a, lyase

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Regimen 1: 7dayPM+DT

Arm Type

Experimental

Arm Description

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.

Arm Title

Regimen 2: 7dayPM-DT

Arm Type

Experimental

Arm Description

VT-464: given orally once daily in 28 day cycles. Dosing in the evening before bed 7-days a week without dose titration.

Arm Title

Regimen 3: 7dayAM+DT

Arm Type

Experimental

Arm Description

VT-464: given orally once daily in 28 day cycles. Dosing in the morning 7-days a week with a 2-week dose titration.

Arm Title

Regimen 4: 7dayAM-DT

Arm Type

Experimental

Arm Description

VT-464: given orally once daily in 28 day cycles.Dosing in the morning 7-days a week without dose titration.

Arm Title

Regimen 5: 5dayPM-DT

Arm Type

Experimental

Arm Description

VT-464: given orally once daily in 28 day cycles.Dosing in the evening before bed 5-days a week without dose titration.

Arm Title

Regimen 6: 5dayAM-DT

Arm Type

Experimental

Arm Description

VT-464: given orally once daily in 28 day cycles.Dosing in the morning 5-days a week without dose titration.

Intervention Type

Drug

Intervention Name(s)

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

Other Intervention Name(s)

VT-464

Intervention Description

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

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

Peak Plasma Concentration (Cmax) of VT-464

Time Frame

After the first dose of VT-464

Title

Area under the plasma concentration versus time curve (AUC) of VT-464

Time Frame

After the first dose of VT-464

Title

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

Time Frame

After the first dose of VT-464

Other Pre-specified Outcome Measures:

Title

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

Title

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

Title

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

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joel Eisner

Organizational Affiliation

Innocrin Pharmaceutical

Official's Role

Study Director

Facility Information:

Facility Name

H. Lee Moffitt Cancer Center and Research Institute

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

Urology Cancer Center

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68130

Country

United States

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

Carolina Urologic Research Center

City

Myrtle Beach

State/Province

South Carolina

ZIP/Postal Code

29572

Country

United States

Facility Name

Virginia Oncology Associates

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23502

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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