Multicenter, Randomised, Double-blind Phase III Trial to Investigate the Efficacy and Safety of BIBF 1120 in Combination With Carboplatin and Paclitaxel Compared to Placebo Plus Carboplatin and Paclitaxel in Patients With Advanced Ovarian Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,366
- 试验地点
- 281
- 主要终点
- PFS Based on Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST), and Additional Clinical Criteria.
研究概览
简要总结
The trial will be performed to evaluate if BIBF 1120 in combination with paclitaxel and carboplatin is more effective than placebo in combination with paclitaxel and carboplatin in first-line treatment of patients with advanced ovarian cancer. Safety information about BIBF1120/paclitaxel/carboplatin will be obtained.
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
- Double
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
BIBF 1120
patients to receive BIBF 1120 standard dose twice daily PO in combination with combination with carboplatin and paclitaxel
干预措施: Carboplatin (Drug)
BIBF 1120
patients to receive BIBF 1120 standard dose twice daily PO in combination with combination with carboplatin and paclitaxel
干预措施: BIBF 1120 (Drug)
BIBF 1120
patients to receive BIBF 1120 standard dose twice daily PO in combination with combination with carboplatin and paclitaxel
干预措施: Paclitaxel (Drug)
Placebo
patients to receive capsules identical to those containing BIBF 1120 in combination with combination with carboplatin and paclitaxel
干预措施: Placebo (Drug)
Placebo
patients to receive capsules identical to those containing BIBF 1120 in combination with combination with carboplatin and paclitaxel
干预措施: Paclitaxel (Drug)
Placebo
patients to receive capsules identical to those containing BIBF 1120 in combination with combination with carboplatin and paclitaxel
干预措施: Carboplatin (Drug)
结局指标
主要结局
PFS Based on Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST), and Additional Clinical Criteria.
时间窗: First drug administration to date of disease progression or death whichever occurs first , upto 29 months
Progression free survival (PFS) is calculated as the time from randomisation to the date of disease progression, or to the date of death, whichever occurs first according to the Investigator assessment. The primary PFS analysis of this trial was performed when approximately 753 patients had experienced a PFS event Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment arm.
PFS Based on Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST), and Additional Clinical Criteria (Follow up Analysis).
时间窗: First drug administration to date of disease progression or death whichever occurs first until final Data Base Lock (DBL) 26September16, upto 62 months
Follow-up analysis was conducted at the time of overall survival analysis. Progression free survival (PFS) is calculated as the time from randomisation to the date of disease progression, or to the date of death, whichever occurs first according to the Investigator assessment. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment arm.
次要结局
- PFS Based on Investigator Assessment According to mRECIST Version 1.1 (Key Secondary Endpoint - Follow up Analysis).(First drug administration to date of disease progression or death whichever occurs first until final Data Base Lock (DBL) 26September16, upto 62 months)
- Time to CA-125 Tumour Marker Progression(First drug administration until final DBL 26September16, upto 62 months)
- Objective Response Based on Investigator Assessment(First drug administration until final DBL 26September16, upto 62 months)
- Change in Abdominal/Gastro-intestinal Symptoms Over Time(First drug administration until final DBL 26September16, upto 62 months)
- PFS Based on Investigator Assessment According to mRECIST Version 1.1 (Key Secondary Endpoint).(First drug administration to date of disease progression or death whichever occurs first , upto 29 months)
- Overall Survival(First drug administration to date of death until final DBL 26September16, upto 62 months)
- Change in Global Health Status/ Quality of Life (QoL) Scale Over Time.(First drug administration until final DBL 26September16, upto 62 months)