NCT00849550已完成1 期
A Phase I Study of Capecitabine, Oxaliplatin, Bevacizumab, and RAD001 (XELOX-A-Ev) for Subjects With Advanced Solid Tumors
Herbert Hurwitz3 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2009年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 3
- 主要终点
- To determine the MTD/RPTD of capecitabine/oxaliplatin/bevacizumab/everolimus (XELOX-A-Ev) for subjects with advanced solid tumors.
研究概览
简要总结
The purpose of this study is to determine if RAD001 (everolimus) helps improve the standard treatment of XELOX-A (bevacizumab, oxaliplatin, capecitabine) in advanced solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be 18 years or older
- •Must have a performance status of at least 70% (able to carry on most normal activities)
- •Must have life expectancy of at least 3 months
- •Must have adequate organ and marrow function as determined by lab tests
- •Women of child-bearing potential and men must agree to use two forms of contraception
- •Ability and willingness to sign a written informed consent document
- •Histologically confirmed solid tumor malignancy that is metastatic or unresectable
排除标准
- •Pregnant or breastfeeding and/or lactating women
- •Patients who have received any other investigational agents within 28 days of the first day of study drug
- •Patients with known CNS metastases
- •History of other carcinomas within last 5 years (except non-melanoma skin cancer, in-situ cervical cancer, localized prostate cancer)
- •Inadequately controlled hypertension
- •Significant vascular disease
- •Invasion or encasement of a major artery
- •Evidence of bleeding diathesis or coagulopathy
- •Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to day 1 of study drug
- •Serious illness or medical condition
- •History of myocardial infarction, unstable angina, cardiac or other vascular stenting
- •History of stroke
- •HIV, Hepatitis C, Hepatitis B or other serious chronic infection
- •Impairment of Gastrointestinal function or disease
- •History of interstitial lung disease
- •Patients who have had radiation therapy, hormonal therapy, biologic therapy or chemotherapy for cancer within 28 days of receiving study drug.
研究组 & 干预措施
XELOX-A-Ev
Experimental
干预措施: capecitabine/oxaliplatin/bevacizumab/RAD001 (XELOX-A-Ev) (Drug)
结局指标
主要结局
To determine the MTD/RPTD of capecitabine/oxaliplatin/bevacizumab/everolimus (XELOX-A-Ev) for subjects with advanced solid tumors.
时间窗: End of treatment phase
次要结局
- Describe dose-limiting and non-dose-limiting toxicities(End of treatment phase)
- preliminarily investigate the response rate and PFS(from response to progression)
研究者
Herbert Hurwitz
Associate Professor of Medicine
Duke University
研究点 (3)
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