EUCTR2014-005070-11-DK进行中（未招募）1 期
A Phase 3 Placebo-Controlled Study of Carboplatin/Paclitaxel With or Without Concurrent and Continuation Maintenance Veliparib (PARP inhibitor) in Subjects with Previously Untreated Stages III or IV High-Grade Serous Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,100
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
- •Subject must be = 18 years of age
- •High-grade serous adenocarcinoma
- •Willing to undergo testing for gBRCA
- •Eastern Cooperative Oncology Group performance status of 0, 1, or 2
- •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 990
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 110
排除标准
- •Following histologic cell types are ineligible: endometrioid adenocarcinoma, carcinosarcoma, undifferentiated carcinoma, mixed epithelial adenocarcinoma, adenocarcinoma not otherwise specified, mucinous adenocarcinoma, clear cell adenocarcinoma, low-grade serous adenocarcinoma, or malignant Brenner's tumor.
- •Synchronous primary endometrial cancer, or a past history of endometrial cancer.
- •Prior radiotherapy to any portion of the abdominal cavity or pelvis
- •Clinically significant uncontrolled condition(s), including but not limited to: Bowel obstruction or gastric outlet obstruction.
- •History or evidence upon physical examination of central nervous system (CNS) disease.
研究者
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