NCT00179699终止1 期
Phase I Open-Label, Dose Escalation Study To Determine The Maximum Tolerated Dose And To Evaluate The Safety Profile Of Lenalidomide (Revlimid®, CC-5013) With Pemetrexed In Subjects With Advanced Non-Small Cell Lung Cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 40
- 试验地点
- 10
- 主要终点
- To determine the maximum tolerated dose (MTD) and evaluate the safety profile of oral lenalidomide on days 1-14 and pemetrexed on day 1 every 21 days, as combination therapy to subjects with advanced Non-Small Cell Lung Cancer
研究概览
简要总结
Study will deteremine the MTD and evaluate the safety profile of oral lenalidomide on days 1-14 when combined with pemetrexed on day 1 of a 21 days cycle. Subjects will continue on study until documention of disease progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 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
- •Subjects must understand and voluntarily sign an informed consent document.
- •Age >or= 18 years at the time of signing informed consent form.
- •Subjects must be able to adhere to the study visit schedule and other protocol requirements.
- •Histological or cytologic documentation of advanced NSCLC.
- •Radiographic or clinical evidence of measurable advanced NSCLC. Subjects must have measurable disease at least 2 cm in diameter.
- •Subjects must have been treated and progressed following chemotherapy.
- •ECOG performance status of 0 or 1 (Appendix I: ECOG Performance Status Scale).
- •Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 7 days of starting study drug. In addition, sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on study drug.
排除标准
- •Any of the following laboratory abnormalities:
- •Absolute neutrophil count (ANC) <1,500 cells/mm3 (1.5 x 109/L)
- •Platelet count <100,000 cells/mm3 (100 x 109/L)
- •Serum creatinine >1.5 mg/dL (133 mmol/L)
- •Serum SGOT/AST or SGPT/ALT >3.0 x upper limit of normal (ULN)
- •Serum total bilirubin >or = 1.5 mg/dL (26 mmol/L)
- •Any serious medical condition or psychiatric illness that places the subject at an unacceptable risk for study participation or would prevent the subject from signing the informed consent.
- •Prior history of malignancy (except basal cell or squamous cell carcinoma or carcinoma in situ of the breast) unless the subject has been free of disease for > 1 year.
- •Known brain or leptomeningeal disease (CT scan or MRI of the brain required only in case of clinical suspicion of central nervous system involvement).
- •More than one prior chemotherapy for advanced NSCLC.
- •Concurrent use of any other anti-cancer agents.
- •Any prior use of lenalidomide.
- •Pregnant or lactating females.
- •Prior > or = to grade 3 rash or any desquamating (blistering) rash while taking thalidomide.
- •Prior > or = to grade 3 allergic reaction/hypersensitivity to thalidomide.
- •Use of any standard/experimental anti-cancer drug therapy within 28 days of the initiation of study drug therapy.
- •Known Hepatitis C.
结局指标
主要结局
To determine the maximum tolerated dose (MTD) and evaluate the safety profile of oral lenalidomide on days 1-14 and pemetrexed on day 1 every 21 days, as combination therapy to subjects with advanced Non-Small Cell Lung Cancer
次要结局
- To explore the anit-tumor activity of the combination of lenalidomide and pemetrexed when given to subjects with advanced NSCLC
研究者
研究点 (10)
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