A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL OF WEEKLY PACLITAXEL PLUS AMG 386 OR PLACEBO IN WOMEN WITH RECURRENT PARTIALLY PLATINUM SENSITIVE OR RESISTANT EPITHELIAL OVARIAN, PRIMARY PERITONEAL OR FALLOPIAN TUBE CANCERS

AMGEN INC.,0 个研究点目标入组 6 人开始时间: 2011年5月19日最近更新: 2023年9月4日

适应症

试验速览

阶段: 未知
状态: 已完成
发起方
入组人数: 6

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 18 至 80（—）
性别: Female

入选标准

•Female 18 years of age or older at the time the written informed consent is obtained
•Gynecologic Oncology Group (GOG) Performance Status of 0 or 1
•Life expectancy >= 3 months (per investigator opinion)
•Histologically or cytologically documented invasive epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer (Subjects with pseudomyxoma , mesothelioma, unknown primary tumor, sarcoma, or neuroendocrine histology, with borderline ovarian cancer, ie, subjects with low malignant potential tumors, and with clear cell or mucinous histology are excluded)
•Subjects must have undergone surgery for ovarian cancer, primary peritoneal cancer, or fallopian tube cancer including at least a unilateral oophorectomy
•Radiologically evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 with modifications
•Subjects must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound. This initial treatment may have included intraperitoneal therapy, high-dose therapy, consolidation therapy, bevacizumab or extended therapy administered after surgical or non-surgical assessment.
•Adequate organ and hematological function
•Generally well controlled blood pressure with systolic blood pressure <= 140 mmHg and diastolic blood pressure <= 90 mmHg prior to randomization. The use of anti-hypertensive medications to control hypertension is permitted
•Radiographically documented disease progression either on or following the last dose of prior chemotherapy regimen for epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer

排除标准

•Subjects who have received more than 3 previous regimens of anti-cancer therapy for epithelial ovarian, primary peritoneal or fallopian tube cancers
•Subjects who have received paclitaxel as consolidation therapy, maintenance, or monotherapy are excluded
•Subjects with primary platinum-refractory disease
•Subjects with platinum-free interval (PFI) > 12 months from their last platinum based therapy
•Radiotherapy <= 14 days prior to randomization. Subjects must have recovered from all radiotherapy-related toxicities
•Previous abdominal or pelvic radiotherapy
•History of arterial or venous thromboembolism within 12 months prior to randomization
•History of clinically significant bleeding within 6 months prior to randomization
•History of central nervous system metastasis
•Has not yet completed a 21 day washout period prior to randomization for any previous anti cancer systemic therapies (30 days for prior bevacizumab)
•Enrolled in or has not yet completed at least 30 days (prior to randomization) since ending other investigational device or drug, or currently receiving other investigational treatments
•Unresolved toxicities from prior systemic therapy that are Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 >= Grade 2 in severity except alopecia
•Known active or ongoing infection (except uncomplicated urinary tract infection [UTI]) within 14 days prior to randomization
•Currently or previously treated with AMG 386, or other molecules that inhibit the angiopoietins or Tie2 receptor
•Treatment within 30 days prior to randomization with strong immune modulators including but not limited to systemic cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, methotrexate, azathioprine, rapamycin, thalidomide, and lenalidomide
•Clinically significant cardiovascular disease within 12 months prior to randomization
•Major surgery within 28 days prior to randomization or still recovering from prior surgery
•Minor surgical procedures, except placement of tunneled central venous access device within 3 days prior to randomization. Diagnostic laparoscopy is regarded as a minor surgical procedure.

研究者

发起方

AMGEN INC.,

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