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Completed

NCT Number: NCT02130700

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

National Institutes of Health, National Cancer Institute

Bethesda, Maryland, 20892, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

Oral VT-464 given twice daily, in continuous 28-day cycles at the recommended Phase 2 dose

Other names: VT-464

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

Drug

Oral VT-464 given once daily, in continuous 28-day cycles at the recommended Phase 2 dose

Other names: seviteronel

Primary outcomes

  1. The change in PSA from baseline using waterfall plots in response to 12-weeks of treatment with VT-464

    Time frame: 12 weeks

    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.

  2. Progression-free survival using Kaplan-Meier curves

    Time frame: 8 months

    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.

  3. 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

    Time frame: 16 weeks

    Clinical benefit rate will be measured at designated timepoints as listed per protocol

  4. 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

    Time frame: 24 weeks

    Clinical benefit rate will be measured at designated timepoints as listed per protocol

Secondary outcomes

  1. Overall survival using Kaplan-Meier curves

    Time frame: 32 months

    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.

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

    Time frame: 8 months

    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.

  3. Maximum PSA response compared to baseline

    Time frame: 8 months

    Maximum PSA response will be descriptive in nature and presented for each cohort as a percent of patients and as a waterfall plot.

Sponsors and collaborators

Lead sponsor

Innocrin Pharmaceutical

Industry

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
May 5, 2014
Registry last updated
May 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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