A Phase I/II Study of RAD001 in Advanced Hepatocellular Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 3
- 主要终点
- Progression-free Survival Rate at 24 Weeks
研究概览
简要总结
Laboratory studies have shown that RAD001 can prevent cells from multiplying. Consequently, the study drug is being tested in medical conditions in which excessive cell multiplication (as in cancer) needs to be stopped. The main purpose of this research study is to find the highest dose of RAD001 that can be given safely (without causing severe side effects) and to learn the effects (good or bad) RAD001 has on participants with liver cancer.
详细描述
- Participants will be given a supply of the study drug RAD001 to be taken at home. They will be asked to take the study drug every morning on an empty stomach and will be given a study drug diary to record the time/date each time they take RAD001. Each 6 week period of time is called a cycle of study treatment.
- We are looking for the highest dose of RAD001 that can be given safely. Therefore not every participant will receive the same dose of RAD001.
- Participants will come to the clinic every other week. At each of these visits, a physical examination and blood tests will be performed.
- A CT and MRI will be repeated every 6 weeks during the first 3 cycles of treatment then every 12 weeks thereafter.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unresectable of metastatic HCC. Patients must have prior core biopsy to confirm the diagnosis of HCC and have archived tissues available for correlative studies
- •At least one measurable site of disease according to RECIST criteria that has not been previously irradiated. If it has had previous radiation to teh marker lesion(s), there must be evidence of progression since the radiation
- •0-2 prior systemic chemotherapy and biologic regimens for hepatocellular carcinoma
- •Patients with prior chemoembolization history can participate in the study if the chemoembolization was performed more than 4 weeks ago and patients must have measurable disease outside of prior chemoembolization field
- •18 years of age or older
- •Minimum of 4 weeks since any major surgery or completion of radiation
- •Minimum of 4 weeks since completion of all prior systemic anticancer therapy
- •ECOG performance status of 0-2
- •CLIP score of equal to or less then 3
- •Adequate bone marrow, liver and renal function as outlined in the protocol
排除标准
- •Prior treatment with any investigational drug within the preceding 4 weeks
- •Chronic treatment with systemic steroids or another immunosuppressive agent
- •Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases
- •Patients with any severe and/or uncontrolled medical conditions or other condition that could affect participation in the study
- •Known history of HIV seropositivity
- •Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001
- •Active, bleeding diathesis
- •Women who are pregnant or breast feeding
- •Patients who have received prior treatment with an mTor inhibitor
- •Patients with known hypersensitivity to RAD001 or other rapamycins or its excipients
- •History of non-compliance to medical regimens
- •Patients with a positive dipstick for urine protein (reading of 2+ or greater) will then undergo a 24-hour urine collection for protein. If patients have a 2g or greater of protein/24hr, they will be excluded from the study.
研究组 & 干预措施
RAD001
Patients will receive RAD001 10 mg/day orally (6 weeks/cycle). Patients will be continued on treatment until disease progression, limiting toxicity, patient withdrawal of consent, or death.
干预措施: RAD001 (Drug)
结局指标
主要结局
Progression-free Survival Rate at 24 Weeks
时间窗: 2 years
Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions" This information will be collected during two years of patient participation.
Maximum Tolerated Dose of RAD001 in Patients With Advanced Hepatocellular Carcinoma (HCC).
时间窗: 2 years
次要结局
- Time to Progression(2 years)
- Number of Patients With Adverse Events Who Were Treated With RAD001 for Advanced HCC(2 years)
- Overall Response Rate(2 years)
- Overall Survival(2 years)
研究者
Andrew X. Zhu, MD
Principal Investigator
Massachusetts General Hospital