A Phase 1/2 Open-Label Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Seviteronel in Subjects With Advanced Breast Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 175
- 试验地点
- 36
- 主要终点
- Estimate efficacy of seviteronel as measured by clinical benefit rate at 16 weeks (CBR16) for female subjects with TNBC.
研究概览
简要总结
The goal of this clinical study is to determine the safety, pharmacokinetics, pharmacodynamics and efficacy and activity of seviteronel, a lyase-selective inhibitor of CYP17, in patients with advanced breast cancer.
详细描述
This is an open-label, Phase 1/2 study of seviteronel in subjects with TNBC or ER +/HER2 normal unresectable locally advanced breast cancer. Only women will be enrolled in Phase 1 and both men and women enrolled into their respective cohorts in Phase 2. There will be a dose confirmation Phase 1 portion of the study to establish the recommended Phase 2 dose (RP2D) for women with breast cancer using a non-stratified, combined cohort of women with TNBC or ER+ BC. Cohort expansion will occur in Phase 2 at the RP2D confirmed/established in Phase 1 using separate TNBC and ER+ cohorts. The Phase 2 portion of the study is divided into three parallel cohorts:
Cohort 1: Female TNBC Subjects Cohort 2: Female ER+ Subjects Cohort 3: Male ER+ BC or TNBC Subjects
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
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Female Triple Negative Breast Cancer Patients
TNBC Patients - Enrollment is complete in this cohort
干预措施: Seviteronel (Drug)
Female Estrogen Receptor (+) Breast Cancer Patients
Female ER(+) BC Patients - Enrollment is complete in this cohort
干预措施: Seviteronel (Drug)
Male Breast Cancer Patients
Locally advanced or metastatic males with BC
干预措施: Seviteronel (Drug)
结局指标
主要结局
Estimate efficacy of seviteronel as measured by clinical benefit rate at 16 weeks (CBR16) for female subjects with TNBC.
时间窗: Duration of Study
Estimate efficacy of seviteronel as measured by clinical benefit rate at 24 weeks (CBR24) for female subjects with ER+ BC.
时间窗: Duration of Study
Estimate efficacy of seviteronel as measured by CBR16 for all male BC subjects.
时间窗: Duration of Study
次要结局
- Describe the pharmacokinetics of seviteronel(At least monthly over the first eight 28-day cycles)
- Estimate efficacy of seviteronel as measured by the overall response rate (ORR) based on RECIST 1.1(At least monthly over the first eight 28-day cycles)
- Estimate efficacy of seviteronel as measured by progression-free survival (PFS)(At least monthly over the first eight 28-day cycles)
- Describe the safety profile of seviteronel(Duration of the study)
- Compare the safety profile of seviteronel with or without concurrent glucocorticoid administration(Duration of the study)
- Compare the CBR16 with or without concurrent glucocorticoid administration for female subjects with TNBC(Duration of the study)