A Phase 1 Study for the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics Evaluation of SAR439859, Administered Orally as Monotherapy in Japanese Postmenopausal Women With Estrogen Receptor-Positive And Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer (AMEERA-2)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 10
- 试验地点
- 3
- 主要终点
- Investigational medicinal product (IMP)-related dose limiting toxicities (DLTs)
研究概览
简要总结
Primary Objective:
To assess the incidence rate of dose-limiting toxicity and to confirm the recommended dose as well as the maximum tolerated dose of SAR439859 administered as monotherapy to Japanese postmenopausal women with estrogen receptor positive and human epidermal growth factor receptor 2-negative advanced breast cancer.
Secondary Objective:
- To characterize the overall safety profile of SAR439859 administered as monotherapy.
- To characterize the pharmacokinetic profile of SAR439859 administered as monotherapy.
- To evaluate the antitumor activity of SAR439859 administered as monotherapy and the clinical benefit rate (complete response, partial response and stable disease ≥ 24 weeks).
详细描述
The duration of the study for an individual participant will include a period to assess eligibility (screening period) of up to 4 weeks (28 days), a treatment period of at least 1 cycle (28 days) of study treatment, and an End of Treatment (EOT) visit at least 30 days (or until the participant receives another anticancer therapy, whichever is earlier) following the last administration of study treatment. Study treatment may continue until precluded by unacceptable toxicity, disease progression, or upon participant's request.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 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
SAR439859
administered orally once daily or twice daily as monotherapy in fasted or fed state
干预措施: Amcenestrant (SAR439859) (Drug)
结局指标
主要结局
Investigational medicinal product (IMP)-related dose limiting toxicities (DLTs)
时间窗: Day 1 to Day 28
Incidence rate of study treatment-related DLTs at Cycle 1
次要结局
- Safety: Adverse Events (AEs)(Up to 30 days after administration of study treatment)
- Assessment of Pharmacokinetic parameter of SAR439859: tlag(Day 1 and Day 22 of Cycle 1 (28 days))
- Assessment of Pharmacokinetic parameter of SAR439859: Ctrough(Day 1, Day 8, Day 15 and Day 22 of Cycle 1 (28 days) and Day 1 of Cycle 2)
- Assessment of Pharmacokinetic parameter of SAR439859: Cmax(Day 1 and Day 22 of Cycle 1 (28 days))
- Assessment of antitumor activity: Duration of response(64 weeks)
- Assessment of Pharmacokinetic parameter of SAR439859: tmax(Day 1 and Day 22 of Cycle 1 (28 days))
- Assessment of antitumor activity: Clinical benefit rate (CBR)(64 weeks)
- Assessment of Pharmacokinetic parameter of SAR439859: AUC0-24h or AUC0-10h and/or AUC0-12h(Day 1 and Day 22 of Cycle 1 (28 days))
- Assessment of antitumor activity: Objective response rate (ORR)(64 weeks)
- Assessment of antitumor activity: Non-progression rate(64 weeks)