NCT00412828已完成1 期
A Phase I/II Study of CR011-vcMMAE in Subjects With Unresectable Stage III or Stage IV Melanoma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 117
- 试验地点
- 7
- 主要终点
- to evaluate the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT)
研究概览
简要总结
This study will evaluate the safety, tolerability and pharmacokinetics of CR011-vcMMAE in patients who have unresectable stage III or stage IV melanoma and have failed no more than 1 line of prior cytotoxic therapy. CR011-vcMMAE will be administered intravenously (IV) once every 3 weeks at escalating doses until the maximum tolerated dose (MTD) is reached. Once the MTD is defined, 18-32 patients will be enrolled to further evaluate the safety and efficacy of CR011-vcMMAE at this dose level. Additional dosing schedules of CR011-vcMMAE will also be explored.
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
- •Male or female with age ≥ 18 years.
- •Progressive or new metastatic melanoma, stage III or IV.
- •Measurable disease by CT / MRI
- •Failure of no more than 1 line of prior cytotoxic therapy.
- •Adequate bone marrow, renal and hepatic function
- •Leukocytes ≥ 3000/mm3, ANC ≥ 1,500 cells/mm3, Platelets ≥ 100,000/mm3
- •Hemoglobin ≥ 10 g/dL (transfusion allowed)
- •Total bilirubin ≤ 1.5 x upper normal limit (UNL)
- •AST (SGOT), ALT (SGPT) ≤ 3.0 x UNL (≤ 5.0 x UNL may be acceptable)
- •Serum creatinine ≤ 1.5 mg/dL or calculated creatinine clearance > 45 mL/min/1.73 m2
- •PT/aPTT < 1.5 x UNL or within therapeutic range via anti-coagulation therapy
- •Karnofsky PS ≥ 70%.
- •Estimated life expectancy > 3 months.
- •Signed informed consent approved IRB and ability to comply with the study or monitoring procedures.
- •Subjects with evaluable disease are eligible in dose-escalation cohorts
排除标准
- •Prior therapies for disease under study less than 4 weeks prior to enrollment.
- •Major surgery or trauma within 4 weeks of enrollment.
- •Active brain metastases
- •Active chronic inflammatory, autoimmunity, immunodeficiency disease, and vascular or hemorrhagic disorders.
- •History of allergic reactions to dolastatin, auristatin or compounds of similar composition.
- •Significant cardiovascular disease
- •Other malignancies
- •Pregnancy or breast feeding
- •Refusal or inability to use effective means of contraception (for men, and women with childbearing potential)
- •History of or test-positive to HIV, or hepatitis B or C
结局指标
主要结局
to evaluate the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT)
时间窗: throughout the study
次要结局
- to assess the pharmacodynamics and pharmacokinetics of CRO11-vcMMAE(throughout the study)
- to evaluate the immune response to CR011-vcMMAE(throughout the study)
- to explore clinical anti-tumor response of CR011-vcMMAE in subjects with advanced metastatic melanoma(throughout the study)
研究者
研究点 (7)
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