ONO-4578-06: Phase I , Open-label, Non-blind, First-line Endocrine Therapy With ONO-4578 and Standard Treatment Letrozole and CDK4/6 Inhibitors (Palbociclib or Abemaciclib) in Patients With Metastatic or Recurrent Postmenopausal Hormone Receptor-positive HER2-negative Breast Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 21
- 主要终点
- Dose-limiting toxicity (Tolerability Confirmation part only)
研究概览
简要总结
This is a multicenter, open-label, non-controlled, phase I study to investigate the tolerability and safety of ONO-4578 used in combination with standard-of-care letrozole and a CDK4/6 inhibitor (palbociclib or Abemaciclib) as first-line endocrine therapy in postmenopausal patients with metastatic or recurrent hormone receptor-positive, HER2-negative breast cancer.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with postmenopausal metastatic or recurrent breast cancer
- •Patients with ECOG Performance Status 0 to 1
- •ER-positive, PgR-positive and HER2-negative patients
排除标准
- •Patients are unable to swallow oral medications
- •Patients with severe complication
研究组 & 干预措施
ONO-4578 + letrozole + palbociclib
干预措施: ONO-4578 (Drug)
ONO-4578 + letrozole + palbociclib
干预措施: letrozole (Drug)
ONO-4578 + letrozole + abemaciclib
干预措施: ONO-4578 (Drug)
ONO-4578 + letrozole + palbociclib
干预措施: Palbociclib (Drug)
ONO-4578 + letrozole + abemaciclib
干预措施: abemaciclib (Drug)
ONO-4578 + letrozole + abemaciclib
干预措施: letrozole (Drug)
结局指标
主要结局
Dose-limiting toxicity (Tolerability Confirmation part only)
时间窗: 28 days
Systolic/diastolic blood pressure
时间窗: Through study completion, an average of 4 year
Saturation of Percutaneous Oxygen (SpO2)
时间窗: Through study completion, an average of 4 year
Serious adverse events
时间窗: Through study completion, an average of 4 year
Pulse rate
时间窗: Through study completion, an average of 4 year
Weight
时间窗: Through study completion, an average of 4 year
Adverse events
时间窗: Through study completion, an average of 4 year
Laboratory abnormality profile of Drugs as measured by incidence and severity of clinical laboratory abnormalities
时间窗: Through study completion, an average of 4 year
Body temperature
时间窗: Through study completion, an average of 4 year
Eastern Cooperative Oncology Group Performance Status
时间窗: Through study completion, an average of 4 year
Chest X-ray
时间窗: Through study completion, an average of 4 year
CT scan
时间窗: Through study completion, an average of 4 year
12-lead electrocardiography (RR interval)
时间窗: Through study completion, an average of 4 year
12-lead electrocardiography (PR interval)
时间窗: Through study completion, an average of 4 year
12-lead electrocardiography (Heart rate)
时间窗: Through study completion, an average of 4 year
12-lead electrocardiography (QRS width)
时间窗: Through study completion, an average of 4 year
12-lead electrocardiography (QT interval)
时间窗: Through study completion, an average of 4 year
次要结局
- Best overall response (BOR)(Through study completion, an average of 4 year)
- Overall response rate (ORR)(Through study completion, an average of 4 year)
- Disease control rate (DCR)(Through study completion, an average of 4 year)
- Clinical benefit rate (CBR)(Through study completion, an average of 4 year)
- Overall survival (OS)(Through study completion, an average of 4 year)
- Progression-free survival (PFS)(Through study completion, an average of 4 year)
- Duration of response (DOR)(Through study completion, an average of 4 year)
- Time to response (TTR)(Through study completion, an average of 4 year)
- Percent change in the sum of diameters of target lesions(Through study completion, an average of 4 year)
- Maximum percent change in the sum of diameters of target lesions(Through study completion, an average of 4 year)
- Changes in tumor markers(Through study completion, an average of 4 year)
- Plasma ONO-4578 concentration(Through study completion, an average of 4 year)