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Oral VT-464 in Patients With Castration-Resistant Prostate Cancer Previously Treated With Enzalutamide, Androgen Receptor Positive Triple-Negative Breast Cancer Patients, and Men With ER Positive Breast Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
VT-464: given orally twice daily in 28-day cycles
VT-464: given orally once daily in 28-day cycles
Sponsored by
Innocrin Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring mCRPC, metastatic, castration-resistant prostate cancer

Eligibility Criteria

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

Key Eligibility Criteria:

  • Patients must have documented histological or cytological evidence of adenocarcinoma of the prostate.
  • Must have progressive, metastatic castration-resistant prostate cancer (mCRPC). There must be radiographic evidence of disease after primary treatment with surgery or radiotherapy that has continued to progress radiographically or biochemically (rising PSA levels on successive measurements) despite adequate androgen-deprivation therapy, which is defined as having undergone bilateral surgical castration or continued treatment on GnRH agonists or antagonists.
  • All patients in this trial must have been treated with enzalutamide.
  • Patients in Cohort 1 will not be allowed to have received prior chemotherapy; patients in Cohort 2 must have received one (and not more) prior course of chemotherapy for mCRPC.

  • Progression must be evidenced and documented by any of the following parameters:

    • PSA progression defined by a minimum of two rising PSA levels with an interval of ≥ 1 week between each determination
    • Appearance of one or more new lesions on bone scan
    • Progressive measurable disease by RECIST 1.1

Sites / Locations

  • National Institutes of Health, National Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Chemotherapy-Naive Patients

Previous Chemotherapy Patients

AR Positive 1 - 9% TNBC

Male ER Positive

AR Positive >10% TNBC

Arm Description

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

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

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

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

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

Outcomes

Primary Outcome Measures

The change in PSA from baseline using waterfall plots in response to 12-weeks of treatment with VT-464
To determine the PSA response as defined by a ≥ 50% decrease in serum PSA per the Prostate Cancer Clinical Trials Working Group 2 criteria after each cycle and after 12 weeks of dosing with VT-464 compared to PSA level at baseline in patients who have been previously treated with enzalutamide.
Progression-free survival using Kaplan-Meier curves
Kaplan-Meier curves of progression-free survival (PFS) will be constructed in each cohort and the median PFS will be determined and informally compared to any available results.
Determine clinical benefit rate (CBR) as defined by complete response (CR), partial response (PR) or stable disease (SD) in women with androgen receptor (AR) positive, triple-negative breast cancer
Clinical benefit rate will be measured at designated timepoints as listed per protocol
Determine clinical benefit rate (CBR) as defined by complete response (CR), partial response (PR) or stable disease (SD) in women with androgen receptor (AR) positive, triple-negative breast cancer
Clinical benefit rate will be measured at designated timepoints as listed per protocol

Secondary Outcome Measures

Overall survival using Kaplan-Meier curves
Overall Survival: will be analyzed similarly to PFS, with a separate Kaplan-Meier curve for each arm. A patient for whom there is no death event will be censored; the censored date will be the date of last contact.
The safety and tolerability of VT-464 by evaluating adverse events, vital signs, physical examination findings, concomitant medications and laboratory tests.
The safety of VT-464 will be evaluated by laboratory evaluation, electrocardiogram, the report of adverse events and concomitant medications at each 28-day cycle of treatment and 4-5 weeks after therapy has been discontinued.
Maximum PSA response compared to baseline
Maximum PSA response will be descriptive in nature and presented for each cohort as a percent of patients and as a waterfall plot.

Full Information

First Posted
April 22, 2014
Last Updated
May 2, 2018
Sponsor
Innocrin Pharmaceutical
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02130700
Brief Title
Oral VT-464 in Patients With Castration-Resistant Prostate Cancer Previously Treated With Enzalutamide, Androgen Receptor Positive Triple-Negative Breast Cancer Patients, and Men With ER Positive Breast Cancer
Official Title
A Phase 2 Open-Label Study to Evaluate the Efficacy and Safety of VT-464 in Patients With Metastatic Castration Resistant Prostate Cancer Who Have Previously Been Treated With Enzalutamide, Androgen Receptor Positive Triple-Negative Breast Cancer Patients, and Men With ER Positive Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Innocrin Pharmaceutical
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this clinical study is to determine the safety and efficacy of VT-464, a lyase-selective inhibitor of CYP17, in patients with castration-resistant prostate cancer (CRPC) who have been previously treated with Enzalutamide, Androgen Receptor Positive Triple-Negative Breast Cancer Patients, and Men with ER positive Breast Cancer.
Detailed Description
This is a Phase 2 open-label study of VT-464 in patients with progressive, metastatic castration-resistant prostate cancer (mCRPC) who have been previously treated with enzalutamide, female patients with triple negative, AR positive breast cancer and men with ER positive breast cancer. The study consists of five cohorts: patients in Cohort 1 must have never received prior chemotherapy. Patients in Cohort 2 must have received at least one (and not more) prior course of chemotherapy for CRPC. Women with TNBC will be stratified into two cohorts AR 1 to 9% (cohort 3) and AR > 10% (cohort 4). Cohort 5 will consist of men who have been diagnosed with ER+ breast cancer and have failed at least one prior endocrine therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
mCRPC, metastatic, castration-resistant prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chemotherapy-Naive Patients
Arm Type
Experimental
Arm Description
VT-464: given orally twice daily in 28-day cycles
Arm Title
Previous Chemotherapy Patients
Arm Type
Experimental
Arm Description
VT-464: given orally twice daily in 28-day cycles
Arm Title
AR Positive 1 - 9% TNBC
Arm Type
Experimental
Arm Description
VT-464: given orally once daily in 28-day cycles
Arm Title
Male ER Positive
Arm Type
Experimental
Arm Description
VT-464: given orally once daily in 28-day cycles
Arm Title
AR Positive >10% TNBC
Arm Type
Experimental
Arm Description
VT-464: given orally once daily in 28-day cycles
Intervention Type
Drug
Intervention Name(s)
VT-464: given orally twice daily in 28-day cycles
Other Intervention Name(s)
VT-464
Intervention Description
Oral VT-464 given twice daily, in continuous 28-day cycles at the recommended Phase 2 dose
Intervention Type
Drug
Intervention Name(s)
VT-464: given orally once daily in 28-day cycles
Other Intervention Name(s)
seviteronel
Intervention Description
Oral VT-464 given once daily, in continuous 28-day cycles at the recommended Phase 2 dose
Primary Outcome Measure Information:
Title
The change in PSA from baseline using waterfall plots in response to 12-weeks of treatment with VT-464
Description
To determine the PSA response as defined by a ≥ 50% decrease in serum PSA per the Prostate Cancer Clinical Trials Working Group 2 criteria after each cycle and after 12 weeks of dosing with VT-464 compared to PSA level at baseline in patients who have been previously treated with enzalutamide.
Time Frame
12 weeks
Title
Progression-free survival using Kaplan-Meier curves
Description
Kaplan-Meier curves of progression-free survival (PFS) will be constructed in each cohort and the median PFS will be determined and informally compared to any available results.
Time Frame
8 months
Title
Determine clinical benefit rate (CBR) as defined by complete response (CR), partial response (PR) or stable disease (SD) in women with androgen receptor (AR) positive, triple-negative breast cancer
Description
Clinical benefit rate will be measured at designated timepoints as listed per protocol
Time Frame
16 weeks
Title
Determine clinical benefit rate (CBR) as defined by complete response (CR), partial response (PR) or stable disease (SD) in women with androgen receptor (AR) positive, triple-negative breast cancer
Description
Clinical benefit rate will be measured at designated timepoints as listed per protocol
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Overall survival using Kaplan-Meier curves
Description
Overall Survival: will be analyzed similarly to PFS, with a separate Kaplan-Meier curve for each arm. A patient for whom there is no death event will be censored; the censored date will be the date of last contact.
Time Frame
32 months
Title
The safety and tolerability of VT-464 by evaluating adverse events, vital signs, physical examination findings, concomitant medications and laboratory tests.
Description
The safety of VT-464 will be evaluated by laboratory evaluation, electrocardiogram, the report of adverse events and concomitant medications at each 28-day cycle of treatment and 4-5 weeks after therapy has been discontinued.
Time Frame
8 months
Title
Maximum PSA response compared to baseline
Description
Maximum PSA response will be descriptive in nature and presented for each cohort as a percent of patients and as a waterfall plot.
Time Frame
8 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Eligibility Criteria: Patients must have documented histological or cytological evidence of adenocarcinoma of the prostate. Must have progressive, metastatic castration-resistant prostate cancer (mCRPC). There must be radiographic evidence of disease after primary treatment with surgery or radiotherapy that has continued to progress radiographically or biochemically (rising PSA levels on successive measurements) despite adequate androgen-deprivation therapy, which is defined as having undergone bilateral surgical castration or continued treatment on GnRH agonists or antagonists. All patients in this trial must have been treated with enzalutamide. Patients in Cohort 1 will not be allowed to have received prior chemotherapy; patients in Cohort 2 must have received one (and not more) prior course of chemotherapy for mCRPC. Progression must be evidenced and documented by any of the following parameters: PSA progression defined by a minimum of two rising PSA levels with an interval of ≥ 1 week between each determination Appearance of one or more new lesions on bone scan Progressive measurable disease by RECIST 1.1
Facility Information:
Facility Name
National Institutes of Health, National Cancer Institute
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Oral VT-464 in Patients With Castration-Resistant Prostate Cancer Previously Treated With Enzalutamide, Androgen Receptor Positive Triple-Negative Breast Cancer Patients, and Men With ER Positive Breast Cancer

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