AMELIE: A Phase 3 Randomized, Open-label, Multicenter Trial of Apatinib and Etoposide Capsule Versus Weekly Paclitaxel in Patients With Platinum Resistant or Refractory Ovarian Cancer
试验速览
- 阶段
- 3 期
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Progression free survival(PFS) by independent review committee(IRC)
研究概览
简要总结
The study is conducted to evaluate the efficacy, safety and tolerability of apatinib (375 mg qd) and etoposide capsule (50 mg/d, d1-14, q3w) in subjects with platinum resistant or refractory ovarian cancer compared with weekly paclitaxel (80 mg/m2, d1, d8, d15, q3w).
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- Female
- 接受健康志愿者
- 否
入选标准
- •18 Years and older
- •Epithelial ovarian, fallopian tube or primary peritoneal cancer
- •Platinum refractory and resistant disease (disease progression during platinum therapy or within 6 months of platinum therapy)
- •EOCG performance status of 0-1
排除标准
- •Uncontrolled hypertension ( systolic ≥140 mmHg or diastolic ≥90 mmHg despite antihypertensive therapy)
- •Known hypersensitivity to any of the study drugs or excipients.
- •Known hereditary or acquired bleeding and thrombotic tendencies (e.g. hemophiliacs, coagulation disorders, thrombocytopenia, etc.);
- •Congenital or acquired immune deficiency (e.g. HIV infected)
研究组 & 干预措施
Apatinib and Etoposide capsule
Apatinib (375 mg qd, q3w) and Etoposide capsule(50 mg/d, d1-14, q3w) combination until disease progression or intolerable toxicity
干预措施: Apatinib (Drug)
Apatinib and Etoposide capsule
Apatinib (375 mg qd, q3w) and Etoposide capsule(50 mg/d, d1-14, q3w) combination until disease progression or intolerable toxicity
干预措施: Etoposide (Drug)
Weekly Paclitaxel
Weekly Paclitaxel (80 mg/m2, d1, d8, d15, q3w) until disease progression or intolerable toxicity
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Progression free survival(PFS) by independent review committee(IRC)
时间窗: up to approximately 2 years
PFS was defined as the time from the date of randomization to the first documented disease progression or death, whichever occurred first. Progression was based on tumor assessment made by the IRC according to the RECIST criteria
次要结局
- Overall Survival (OS)(up to approximately 3 years)
- EQ-5D-5L questionnaire(up to approximately 2 years)
- The incidence and severity of adverse events (AEs) and serious adverse events (SAEs)(up to approximately 2 years)
- PFS by investigator(up to approximately 2 years)
- Objective Response Rate (ORR)(up to approximately 2 years)
- FOSI-8 questionnaire(up to approximately 2 years)