NCT00179725终止1 期
Phase I/II Open-Label, Dose Escalation Study To Determine The Maximum Tolerated Dose And To Evaluate The Safety Profile of Lenalidomide (Revlimid®) With Liposomal Doxorubicin In Subjects With Advanced Ovarian and Primary Peritoneal Carcinoma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 60
- 试验地点
- 9
- 主要终点
- Phase I-To determine the maximum tolerated dose (MTD) and evaluate the safety profile of oral lenalidomide on days 1 - 21 and liposomal doxorubicin on day 1 every 28 days, as combination therapy to subjects with advanced ovarian or primary peritoneal ca
研究概览
简要总结
Phase I will determine the MTD and evaluated the safety profile of oral lenalidomide on days 1-21 when given with liposomal doxorubicin on day 1 of every 28 day cycle Phase II will commence once the MTD is established, additional subjects will be enrolled and receive oral lenalidomide on days 1-21 with liposomal doxorubicinon day 1 in 28 day cycles until disease progression is documented.
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
- Female
- 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 or cytological documentation of advanced ovarian or primary peritoneal carcinoma.
- •Radiographic or clinical evidence of measurable metastatic advanced ovarian or primary peritoneal carcinoma. Subjects must have measurable disease at least 2 cm in diameter.
- •Subjects must have been treated and progressed following chemotherapy which includes platinum and paclitaxel.
- •ECOG performance status of 0 or 1 (Appendix I: ECOG Performance Status Scale).
- •Must have 2-d Echocardiogram/MUGA indicating a LVEF above the institutional lower limit of normal within 42 days prior to first dose of 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 >2.5 mg/dL (221 mmol/L)
- •Serum SGOT/AST or SGPT/ALT >3.0 x upper limit of normal (ULN)
- •Serum total bilirubin >1.2 mg/dL (20 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 years.
- •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 1 prior chemotherapy regimen. However, subjects with platinum sensitive disease (i.e., subjects who fail a platinum containing regimen at least six months after completing the regimen) who are retreated with a platinum containing regimen are eligible.
- •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 = grade 3 (see Appendix III) rash or any desquamating (blistering) rash while taking thalidomide.
- •Use of any standard or experimental anti-cancer drug therapy within 28 days of the initiation of study drug therapy.
- •History of cardiac disease, with New York Heart Association Class II or greater (see Appendix V).
- •Subjects who have received > 200mg/m2 of anthracycline or anthracendione either alone or in combination. (Additional caution must be taken in subjects with mediastinal radiation.)
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 on days 1 - 21 and liposomal doxorubicin on day 1 every 28 days, as combination therapy to subjects with advanced ovarian or primary peritoneal ca
Phase II-To explore the anti-tumor activity of the combination of oral lenalidomide on days 1 - 21 and liposomal doxorubicin on day 1 every 28 days when given to subjects with advanced ovarian or primary peritoneal carcinoma.
次要结局
- Phase I-To explore the anti-tumor activity of the combination of lenalidomide and liposomal doxorubicin when given to subjects with advanced ovarian or primary peritoneal carcinoma.
- Phase II-To evaluate the safety profile of the combination of lenalidomide and liposomal doxorubicin when given to subjects with advanced ovarian or primary peritoneal carcinoma
研究者
研究点 (9)
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