A Phase I Dose Finding Study of RAD001 in Combination With Capecitabine and Oxaliplatin (XELOX) in Patients With Advanced Gastric Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To assess the maximum tolerated dose (MTD)
研究概览
简要总结
It is expected that RAD001 works in gastric cancer by inhibiting PI3K/AKT/mTOR pathway and Hif1A (hypoxia inducible factor 1, alpha subunit), a key player in angiogenesis and the growth of tumors like renal cell carcinoma.However, RAD001 alone looks not enough to control gastric cancer. By the mechanisms above, RAD001 can show additive or synergistic effect in combination with conventional chemotherapy. In this study, XELOX was selected as a conventional combination chemotherapy because it was proven very active and safe in gastric cancer. Combination of XELOX and RAD001 has been never tried for the treatment of cancer patients yet. So, the optimal dose will be first determined in this phase I study
详细描述
For the first cohort of this phase I study, each drug of capecitabine, oxaliplatin, and RAD001 will be started at one or two dose below the ordinary full dose of each drug as a single agent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically documented unresectable or metastatic adenocarcinoma of stomach or gastroesophageal junction
- •No history of chemotherapy or radiation
- •Age 18 to 70 years old
- •Estimated life expectancy of at least 3 months
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Adequate bone marrow function (white blood cell counts >3,000/uL, absolute neutrophil count>1,500/uL, Platelets>100,000/uL, Hgb>8 g/dL)
- •Adequate kidney function (creatinine<1.5 mg/dL)
- •Adequate liver function (bilirubin<1.5 mg/dL, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level <3 times the upper normal limit (5 times for patients with liver metastasis))
- •Signed written informed consent
排除标准
- •Past or concurrent history of neoplasm other than gastric adenocarcinoma except for curatively treated basal cell carcinoma of skin or in situ carcinoma of the cervix uteri
- •Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start
- •Presence of central nervous system metastasis
- •Bowel obstruction
- •Evidence of serious gastrointestinal bleeding
- •Peripheral neuropathy (NCI CTC AE version 3.0 > Grade I)
- •History of significant neurologic or psychiatric disorders
- •Pregnant or lactating women, women of childbearing potential not employing adequate contraception
- •Other serious illness or medical conditions
- •Patients with known history of ischemic heart disease and/or with myocardial infarction
- •Known allergy to study drugs
- •Administration of drugs showing interaction with RAD001
研究组 & 干预措施
Xelox+RAD001
干预措施: RAD001, Capecitabine, Oxaliplatin (Drug)
结局指标
主要结局
To assess the maximum tolerated dose (MTD)
时间窗: 1year
次要结局
- Progression-free survival(2 years)
- Overall survival(1 year)
- Biomarker study(1 year)
- Response rate(2 years)
研究者
Yoon-Koo Kang
Professor
Asan Medical Center