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

Amgen Inc.0 个研究点目标入组 1,000 人开始时间: 2012年4月27日最近更新: 2017年10月2日

试验速览

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•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 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
•- 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 os 0 or 1
•Adequate bone marrow, renal and hepatic funtion
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 708
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 313

•Prior use of any anticancer therapy or experimental therapy for epithelial ovarian, primary peritoneal or fallopian tube cancers
•Previous abdonimal 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

发起方

Amgen Inc.