NCT00179751终止1 期
A Phase I/II Study Of Lenalidomide (Revlimid ) In Combination With Gemcitabine In Patients With Untreated Advanced Carcinoma Of The Pancreas
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 50
- 试验地点
- 12
- 主要终点
- Phase I-To determine the maximum tolerated dose (MTD) and evaluate the safety profile of oral lenalidomide days 1- 21 in combination with gemcitabine days 1, 8, and 15 every 28 days in subjects with advanced pancreatic carcinoma.
研究概览
简要总结
Phase I will determine the MDT and evaluate the safety profile of oral lenalidomide days 1-21 and weekly gemcitabine days 1, 8, & 15 in 28 day cycles Phase II will explore the anti-tumor activity and safety of the combination in subjects with advanced pancreatic carcinoma. Subjects will receive oral lenalidomide days 1-21 and weekly gemcitabine days 1, 8, & 15 in 28 day cycles until documented disease progression occurs.
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 = to 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 documentation of advanced pancreatic carcinoma not amenable to curative surgery or definitive radiation.
- •Radiographic or clinical evidence of measurable advanced pancreatic carcinoma. Subjects must have measurable disease at least 2 cm in diameter.
- •Subjects may have been previously treated with radiation therapy and 5-fluorouracil as a radiosensitizer in the adjuvant setting if they currently have evidence of progression.
- •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 medication.
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 >2.5 mg/dL (221 mmol/L)
- •Serum SGOT/AST or SGPT/ALT >3.0 x upper limit of normal (ULN)
- •Serum total bilirubin >2.0 mg/dL (34 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 > or = to 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).
- •Prior use of systemic therapy for the treatment of carcinoma of the pancreas with the exception of 5-fluorouracil as a radiosensitizer in the adjuvant setting.
- •Concurrent use of any other anti-cancer agents.
- •Any prior use of lenalidomide.
- •Prior > or = to grade 3 (see Appendix III) allergic reaction/hypersensitivity to thalidomide.
- •Prior > or = to grade 3 (see Appendix III) rash or any desquamating (blistering) rash while taking thalidomide.
- •Use of any standard/experimental anti-cancer drug therapy within 28 days of the initiation of study drug therapy.
- •Pregnant or lactating females.
结局指标
主要结局
Phase I-To determine the maximum tolerated dose (MTD) and evaluate the safety profile of oral lenalidomide days 1- 21 in combination with gemcitabine days 1, 8, and 15 every 28 days in subjects with advanced pancreatic carcinoma.
Phase II-To explore the anti-tumor activity of the combination of lenalidomide on days 1 - 21 and gemcitabine days 1, 8, and 15 every 28 days in subjects with advanced pancreatic carcinoma.
次要结局
- Phase I-To explore the anti-tumor activity of the combination of lenalidomide and gemcitabine as combination therapy in subjects with advanced pancreatic carcinoma.
- Phase II-To evaluate the safety profile of the combination of lenalidomide and gemcitabine as combination therapy in subjects with advanced pancreatic carcinoma.
研究者
研究点 (12)
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