A Phase II, Double-blind, Placebo-controlled, Multi-centre, Randomised Study of ZD4054 (Zibotentan) Plus Carboplatin and Paclitaxel or Placebo Plus Carboplatin and Paclitaxel in Patients With Advanced Ovarian Cancer Sensitive to Platinum-based Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Progression Free Survival
研究概览
简要总结
The purpose of this study is to compare progression-free survival in patients with advanced ovarian cancer treated with ZD4054 in combination with carboplatin+paclitaxel versus placebo in combination with carboplatin+paclitaxel.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Histologically proven diagnosis of: - Epithelial ovarian carcinoma - Fallopian tube carcinoma - Primary serous peritoneal carcinoma
- •Radiologically documented measurable disease according to RECIST criteria assessed by Computerised Tomography (CT) or Magnetic Resonance Imaging MRI) or radiologically documented non-measurable (but evaluable) disease.
- •Advanced disease not amenable to curative surgery or radiotherapy at the time of study entry with evidence of disease recurrence or progression at least 6 months following treatment cessation of first-line platinum- containing therapy
排除标准
- •Clinical evidence of central nervous system (CNS) metastases
- •Non-epithelial ovarian cancer, including malignant mixed Mullerian tumours and mucinous carcinoma of the peritoneum
- •Tumour of borderline malignancy
研究组 & 干预措施
ZD4054 + paclitaxel + carboplatin
ZD4054 10mg oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
干预措施: ZD4054 Zibotentan (Drug)
ZD4054 + paclitaxel + carboplatin
ZD4054 10mg oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
干预措施: Paclitaxel (Drug)
ZD4054 + paclitaxel + carboplatin
ZD4054 10mg oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
干预措施: Carboplatin (Drug)
Placebo + paclitaxel + carboplatin
Placebo oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
干预措施: Paclitaxel (Drug)
Placebo + paclitaxel + carboplatin
Placebo oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
干预措施: Carboplatin (Drug)
Placebo + paclitaxel + carboplatin
Placebo oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: Patients were followed for progression up to 2 years
Median time (in months) from randomisation until clinical progression of disease using the Kaplan-Meier method.
次要结局
- Tumour Response Rate(While receiving paclitaxel + carboplatin study visits were aliged with its administration ie every 3 weeks, then every 6 weeks (up to 2 years))
- Overall Survival(Patients were followed for survival up to 2 years)