NCT01493505终止3 期
A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study of AMG 386 With Paclitaxel and Carboplatin as First-line Treatment of Subjects With FIGO Stage III-IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Amgen
- 入组人数
- 1,015
- 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 determine whether AMG 386 or AMG 386 Placebo in combination with Paclitaxel and Carboplatin are effective in the treatment of ovarian cancer.
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
- Triple (Participant, Care Provider, Investigator)
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 subjects 18 years of age or older with FIGO Stages III-IV epithelial ovarian, primary peritoneal or fallopian tube cancer with an indication for first-line treatment with paclitaxel and carboplatin x 6 cycles (Subjects with pseudomyxoma, mesothelioma, adenocarcinoma with an unknown primary tumour, carcinosarcoma, sarcoma, mucinous or neuroendocrine histology are excluded
- •Subjects with FIGO Stage IIIA or IIIB disease must have undergone PDS for ovarian, primary peritoneal or fallopian tube cancer within 12 weeks prior to randomization
- •Subjects with FIGO Stage IIIC or IV disease must either:
- •Undergo PDS for epithelial ovarian, primary peritoneal or fallopian tube cancer within 12 weeks prior to randomization or
- •Plan to have IDS following 3 cycles of paclitaxel and carboplatin plus AMG 386 or AMG 386 placebo for biopsy proven epithelial ovarian, primary peritoneal or fallopian tube cancer
- •ECOG performance status of 0 or 1
- •Adequate bone marrow, renal and hepatic function
排除标准
- •Prior use of any anticancer therapy or experimental therapy for epithelial ovarian, primary peritoneal or fallopian tube cancer
- •Previous abdominal and/or pelvic external beam radiotherapy
- •History of central nervous metastasis
- •History of arterial or venous thromboembolism within 12 months prior to randomization
- •Clinically significant cardiovascular disease within 12 months prior to randomization
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo Paclitaxel Carboplatin
干预措施: Paclitaxel (Drug)
Placebo
Placebo Comparator
Placebo Paclitaxel Carboplatin
干预措施: AMG 386 Placebo (Drug)
Placebo
Placebo Comparator
Placebo Paclitaxel Carboplatin
干预措施: Carboplatin (Drug)
AMG 386
Active Comparator
AMG 386 Paclitaxel Carboplatin
干预措施: AMG 386 (Drug)
AMG 386
Active Comparator
AMG 386 Paclitaxel Carboplatin
干预措施: Paclitaxel (Drug)
AMG 386
Active Comparator
AMG 386 Paclitaxel Carboplatin
干预措施: Carboplatin (Drug)
结局指标
主要结局
Progression free survival
时间窗: 3 years
次要结局
- Overall survival (OS)(5 years)
- Patient reported status as measured by the EuroQOL (EQ-5D)(4 years)
- AMG 386 exposure-response relationships for PFS and OS(4 years)
- Incidence of adverse events and significant laboratory abnormalities(4 years)
- Patient reported ovarian cancer-specific symptoms and health related quality of life(4 years)
- Pharmacokinetics of AMG 386 (Cmax and Cmin)(1 year)
- Incidence of anti-AMG 386 antibody formation(4 years)
- Correlation of serum biomarkers with measures of response(4 years)
研究者
研究点 (1)
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