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 - AMG 386 20090508

Amgen Inc.0 个研究点目标入组 900 人开始时间: 2011年2月3日最近更新: 2017年4月3日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 900

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 clinical trial of medicinal product

入排标准

性别: Female

入选标准

•Female of age 18 years or older • 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 are excluded - Subjects with borderline ovarian cancer, ie, subjects with low malignant potential tumors are excluded - Subjects with clear cell or mucinous histology are excluded • Subjects must have undergone surgery for ovarian cancer, primary peritoneal or fallopian tube cancer including at least a unilateral oophorectomy • 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 • Radiologically evaluable disease per RECIST 1.1 with modifications - There must be radiographically visible tumor - Subjects with only ascites or pleural effusion are excluded • 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. - Subjects are allowed to receive, but are not required to receive, two additional cytotoxic regimens for management of recurrent or persistent disease. • GOG performance status 0 or 1 (see Appendix H) • Adequate hematologic, renal and hepatic function
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

排除标准

•Subjects who have received more than three 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 recurrence or progression during the first 6 cycles or < 6 months after the beginning of the first-line platinum-based chemotherapy are excluded • Subjects with platinum-free interval (PFI) > 12 months from their last platinum-based therapy • History of central nervous system metastasis • Clinically significant cardiac disease within 12 months prior to randomization • History of arterial or venous thromboembolism within 12 months prior to randomization • Uncontrolled hypertension as defined as diastolic blood pressure > 90 mmHg OR systolic blood pressure > 140 mmHg • Hypersensitivity to paclitaxel or drugs using the vehicle cremophor

研究者

发起方

Amgen Inc.

相似试验

进行中（未招募）

1 期

A Study of AMG 386 or Placebo, in Combination With Weekly Paclitaxel Chemotherapy, as Treatment for Ovarian Cancer, Primary Peritoneal Cancer and Fallopian Tube CancerRecurrent partially platinum sensitive or resistant epithelial ovarian, primary peritoneal or fallopian tube cancersMedDRA version: 17.0Level: PTClassification code 10066697Term: Ovarian cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

EUCTR2010-019821-32-CZAmgen Inc.919

未知

3 期

AMG 386 2nd Ovarian cancer Global Phase 3 clinical trialRecurrent partially platinum sensitive or resistant epithelial ovarian, primary peritoneal or fallopian tube cancers

JPRN-jRCT2080221277Takeda Pharmaceutical Company Limited900

进行中（未招募）

1 期

EUCTR2010-019821-32-GBAmgen Inc.919

进行中（未招募）

1 期

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 CancersRecurrent partially platinum sensitive or resistant epithelial ovarian, primaryperitoneal or fallopian tube cancersMedDRA version: 12.1Level: LLTClassification code 10066697Term: Ovarian cancer recurrent

EUCTR2010-019821-32-FRAmgen Inc.900

进行中（未招募）

1 期

EUCTR2010-019821-32-GRAmgen Inc.900