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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Progression-free survival using Kaplan-Meier curves
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
Chemotherapy-Naive Patients
VT-464: given orally twice daily in 28-day cycles
干预措施: VT-464: given orally twice daily in 28-day cycles (Drug)
Previous Chemotherapy Patients
VT-464: given orally twice daily in 28-day cycles
干预措施: VT-464: given orally twice daily in 28-day cycles (Drug)
AR Positive 1 - 9% TNBC
VT-464: given orally once daily in 28-day cycles
干预措施: VT-464: given orally once daily in 28-day cycles (Drug)
Male ER Positive
VT-464: given orally once daily in 28-day cycles
干预措施: VT-464: given orally once daily in 28-day cycles (Drug)
AR Positive >10% TNBC
VT-464: given orally once daily in 28-day cycles
干预措施: VT-464: given orally once daily in 28-day cycles (Drug)
结局指标
主要结局
Progression-free survival using Kaplan-Meier curves
时间窗: 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.
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
时间窗: 24 weeks
Clinical benefit rate will be measured at designated timepoints as listed per protocol
The change in PSA from baseline using waterfall plots in response to 12-weeks of treatment with VT-464
时间窗: 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.
次要结局
- Maximum PSA response compared to baseline(8 months)
- Overall survival using Kaplan-Meier curves(32 months)
- The safety and tolerability of VT-464 by evaluating adverse events, vital signs, physical examination findings, concomitant medications and laboratory tests.(8 months)