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

Takeda Pharmaceutical Company Limited0 个研究点目标入组 2,000 人开始时间: 待定

试验速览

暂无简介。

•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

•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

PFS Intergroup trial

未报告次要终点

发起方