Phase II Study of RAD001 in Previously Treated Patients With Metastatic Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 3
- 主要终点
- To Assess Progression-free Survival of RAD001 at Two Months in Patients With Metastatic Pancreatic Cancer Whose Disease Has Progressed on Gemcitabine Chemotherapy.
研究概览
简要总结
The purpose of this research study is to investigate if RAD001 is an effective treatment for pancreatic cancer that has spread and not responded to treatment. Experiments have shown that RAD001 can prevent cells from multiplying. RAD002 has also been tested in laboratory experiments imitating cancer conditions and the results have been promising.
详细描述
- Participants taking part in this research study will be given a study medication-dosing calendar for each treatment cycle. Each cycle lasts four weeks during which you will be taking the study drug, RAD001, orally every day.
- Participants will come into the clinic every other week during the time of enrollment. At each clinic visit blood work will be taken to monitor the participants health and a physical exam will be performed. CT scans will be repeated every 2 months to assess the tumor.
- Participants will remain on the study as long as they continue to benefit from the study medication.
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
- •Pathologic confirmation of pancreatic adenocarcinoma
- •18 years of age or older
- •At least one measurable site of disease according to RECIST criteria that has not been previously irradiated. If patient has had previous radiation to the marker lesion(s), there must be evidence of progression since the radiation.
- •Treated with gemcitabine-based chemotherapy with documented tumor progression on gemcitabine or intolerance to gemcitabine.
- •Prior treatment with no more than 1 prior chemotherapy regimen for metastatic disease.
- •Minimum of two weeks since any major surgery, completion of radiation, or completion of all prior systemic anti-cancer therapy.
- •ECOG performance status 0-
- •Life expectancy of greater than 12 weeks.
- •Adequate bone marrow and liver function.
- •Must be able to swallow tablets.
排除标准
- •Prior treatment with an investigational drug within the preceding 4 weeks.
- •Prior treatment with an inhibitor of mTOR
- •Chronic treatment with systemic steroids or another immunosuppressive agent
- •More than one prior chemotherapy treatment for metastatic disease
- •Uncontrolled brain or leptomeningeal metastases, including patient who continue to require glucocorticoids for brain or leptomeningeal metastases.
- •Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin
- •Patients with chronic renal insufficiency
- •Other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study.
- •Known history of HIV seropositivity
- •Impairment of gastrointestinal function or gastrointestinal disease that my significantly alter the absorption of RAD
- •Active, bleeding diathesis or an oral vitamin K antagonist medication
- •Women who are pregnant or breast feeding
研究组 & 干预措施
RAD001
RAD001 was administered continuously at a dose of 10 mg daily by mouth until disease progression, unacceptable toxicity, or withdrawal of consent.
Four weeks of study drug was considered to be one cycle of treatment.
干预措施: RAD001 (Drug)
结局指标
主要结局
To Assess Progression-free Survival of RAD001 at Two Months in Patients With Metastatic Pancreatic Cancer Whose Disease Has Progressed on Gemcitabine Chemotherapy.
时间窗: two months
The Outcome Measure is reporting the number of participants experiencing Progression-free Survival at 2 months after treatment. The study was designed with a primary end point of progression-free survival (PFS), defined as the time from study entry to documentation of progressive disease or death from any cause. On the basis of prior studies of second-line treatment in metastatic pancreatic cancer, we estimated that such treatment has been associated with a median PFS of 2 months. Our study design used a one-stage design with a target accrual of 35 eligible patients, with the assumption that an improvement in PFS at 2 months from 50% to 71% would warrant further study in this patient population.
次要结局
- to Assess Overall Survival Associated With RAD001 in This Patient Population.(2 years)
- to Assess Response Rate Associated With RAD001 in This Patient Population.(2 years)
- To Assess the Safety of RAD001 in Patients With Metastatic Pancreatic Cancer(Patients were followed for the duration of their time on treatment and 30 days after their last dose of RAD001.)
研究者
Brian Wolpin, MD, MPH
Overall PI
Dana-Farber Cancer Institute