Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of SHR9549 in Women With ER Positive HER2 Negative Advanced Breast Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose (MTD)
研究概览
简要总结
This is a phase 1 open label multicentre study of SHR9549 administered orally in patients with advanced estrogen receptor (ER) positive human epidermal receptor 2 (HER2) negative breast cancer. The study design allows an escalation of dose with intensive safety monitoring to ensure the safety of patients. The study will determine the maximum tolerated dose(MTD). In addition, expansion cohort(s) at potential therapeutic dose(s) in patients will be enrolled to further determine the safety, tolerability, pharmacokinetics and biological activity of SHR9549.
详细描述
A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of SHR9549 in Women with Estrogen Receptor (ER) Positive Human Epidermal Receptor (HER-2) Negative Advanced Breast Cancer
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged 18-70 years.
- •Confirmation of ER positive; HER2 negative Advanced breast cancer
- •Documented disease progression after at least 6 months prior endocrine therapy for ER positive breast cancer.
- •Receipt of ≤2 lines of prior chemotherapy for advanced disease.
- •Any menopausal status.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1 and with minimum life expectancy of 12 weeks.
排除标准
- •Any anti-cancer drugs for the treatment of advanced breast cancer within 14 days of the first dose of study treatment.
- •Any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment with the exception of alopecia.
- •Patient who is unsuitable for endocrine therapy alone including presence of life-threatening metastatic visceral disease.
- •uncontrolled central nervous system metastatic disease.
- •Any evidence of severe or uncontrolled systemic diseases.
- •Inadequate bone marrow reserve or organ function.
研究组 & 干预措施
SHR9549 dose escalation and expansion(s)
Escalating dose of SHR9549 with intensive safety monitoring to ensure the safety of patients
干预措施: SHR9549 (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD)
时间窗: baseline through 28 days
to determine MTD in order to assess the tolerability of SHR9549
Dose Limited Toxicity (DLT)
时间窗: baseline through 28 days
to determine DLT in order to assess the tolerability of SHR9549
次要结局
- Peak Plasma Concentration (Cmax)(baseline through 12 weeks)
- overall response rate (ORR)(every 8 weeks for 24 weeks and then every 12 weeks thereafter through study completion, an average of 6 months)
- progression free survival (PFS)(every 8 weeks for 24 weeks and then every 12 weeks thereafter through study completion, an average of 6 months)
- Incidence of Treatment-Emergent Adverse Events(baseline through 30 days after study completion)
- Area under the plasma concentration versus time curve (AUC)(baseline through 12 weeks)