NCT04383977Unknown2 期
A Phase 2 Randomized, Open-label, Multicenter Trial of Apatinib and Etoposide Capsule Versus Apatinib in Patients With Platinum Resistant or Refractory Ovarian Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 54
- 主要终点
- Objective response rate (ORR) by investigator
研究概览
简要总结
The study is conducted to evaluate the efficacy, safety and tolerability of apatinib (375 mg qd) or apatinib (375 mg qd) and etoposide capsule (50 mg/d, d1-14, q3w) in subjects with platinum resistant or refractory ovarian cancer compared with apatinib (375 mg qd).
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
- •Female patients, ≥18 Years.
- •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 0-2
排除标准
- •Non-epithelial tumours
- •Ovarian tumours with low malignant potential
- •Surgery (including open biopsy) within 4 weeks before starting study therapy or anticipated need for major surgery during study treatment
- •Evidence of rectosigmoid involvement by pelvic examination, bowel involvement on computed tomography, or clinical symptoms of bowel obstruction.
研究组 & 干预措施
Apatinib-Etoposide capsule
Experimental
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 and Etoposide capsule (Drug)
Apatinib
Active Comparator
Apatinib (375 mg qd, q3w) until disease progression or intolerable toxicity
干预措施: Apatinib (Drug)
结局指标
主要结局
Objective response rate (ORR) by investigator
时间窗: up to 2 years
ORR was defined as the proportion of subjects who have a complete or partial response relative to baseline .
次要结局
- AEs+SAEs(30 days after the last dose)
- PFS by investigator(up to 2 years)
- Overall Survival (OS)(up to 3 years)
- Pharmacokinetic characteristic(up to 2 years)
研究者
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