NL-OMON33926尚未招募3 期
A randomized, double-blind phase 3 study of gemcitabine plus AG-013736 versus gemcitabine plus placebo for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer - Gemcitabine versus AG-013736 with pancreascancer
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 12
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 99（—）
入选标准
- •Histologically or cytologically confirmed, metastatic or locally-, advanced pancreatic adenocarcinoma not amenable to curative resection; Adequate coagulation, hepatic and renal function documented within 14 days prior to treatment; Adequate bone marrow function; Male or female, age 18 years or older; ECOG performance status of 0 or 1; Life expectancy of *12 weeks; Resolution of all acute toxic effects of prior therapies, or surgical procedure to NCI CTCAE Grade < or equal to 1; No evidence of preexisting uncontrolled hypertension; negative pregnancy test; Signed and dated informed consent. See also protocol page 27
排除标准
- •Prior treatment with any systemic chemotherapy for metastatic disease; Prior adjuvant chemotherapy or radiotherapy <4 weeks before starting study treatment; Prior treatment with gemcitabine, AG-013736 or other VEGF inhibitors; Gastrointestinal abnormalities; central lung lesions involving major blood vessels; history of hemoptysis; current or recent use of a thrombolytic agent; Current use or anticipated use for treatment with potent CYP3A4 inhibitors/CYP1A2 or CYP3A4 inducers; active seizure disorder; serious uncontrolled medical disorder or active infection; Dementia or significantly altered mental status; Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness; pregnancy or breastfeeding
研究者
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