A Phase II Study of RAD001 (Everolimus) in Patients With Fluoropyrimidine and Platinum-refractory Advanced Gastric Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Progression-free Survival Rate at 4-month (16 Weeks)
研究概览
简要总结
This is a phase II study to evaluate RAD001 (Everolimus) in terms of 4-month progression-free survival rate (primary end-point) and response rate, toxicity, and overall survival (secondary end-points) in patients with metastatic and/or advanced inoperable gastric cancer.
Eligibility criteria include histologically proven gastric/gastroesophageal junction cancer who failed previous first-line standard treatment with fluoropyrimidine and platinum-based chemotherapy.
Oral RAD001 (everolimus) 10mg daily will be administered and the dose will be adjusted according to the observed clinical toxicities. Treatment will be continued until disease progression or patient's intolerability to the study drug.
Total of 54 patients will be enrolled to decide whether the proportion of patients who are free from progression at 4 months (16 weeks), P, is less that or equal to 0.15 or greater than or equal to 0.30 to assess the treatment outcome in 48 patients assuming drop-out rate, 10%.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have histologically or cytologically documented stomach adenocarcinoma including adenocarcinoma of the esophagogastric junction
- •Patients must have non-resectable disease by metastasis or recurrent disease after curative surgical resection with uni-dimensionally measurable disease (at least longest diameter 1 cm on computed tomography scan, or at least 2 cm on chest x-ray or physical examination)
- •Patients tumor should have failure of 1st line chemotherapy including fluoropyrimidine (5-FU, capecitabine, doxifluridine, S1, or UFT) and platinum (cisplatin, carboplatin, or oxaliplatin) in palliative setting; progression during or within 6 months after chemotherapy
- •Age 18 to 75 years old
- •Estimated life expectancy of more than 3 months
- •ECOG performance status of 2 or lower
- •Adequate bone marrow function
- •Adequate kidney function
- •Adequate liver function
- •No prior radiation therapy to more than 25 percent of BM
- •Patients must not have psychological, familial, sociological or geographical conditions which do not permit medical follow-up and compliance with this study
- •Women of childbearing potential must have a negative pregnancy test on admission
- •The patient must be able to understand the study and has given written informed consent to participate in the study
排除标准
- •Other tumor types than adenocarcinoma
- •Central nervous system metastases or prior radiation for CNS metastasis
- •Gastric outlet obstruction or intestinal obstruction
- •Evidence of active gastrointestinal bleeding
- •Bony metastasis as the sole evaluable disease
- •Past or concurrent history of neoplasm other than stomach cancer
- •Pregnant or lactating women, women of childbearing potential not employing adequate contraception
- •Thyroid disease
研究组 & 干预措施
1
Treatment Arm (RAD001)
干预措施: RAD001 (Drug)
结局指标
主要结局
Progression-free Survival Rate at 4-month (16 Weeks)
时间窗: 4 months (16 weeks)
progression is definced as a more than 20% increase in one or more lesions or the appearance of any new lesion
次要结局
- Response Rate(2years)
- Overall Survival(1 year)
- Number of Participants With Adverse Events(up to 24 weeks)
研究者
Yoon-Koo Kang
Professor
Asan Medical Center