NCT00409383Unknown1 期
A Pilot Study of Abraxane® (Albumin-bound Paclitaxel) and Temodar® (Temozolomide) Plus Genasense® (Oblimersen Sodium) in Subjects With Advanced Melanoma ("The ATG Study").
Genta Incorporated1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2006年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Safety based on adverse event reports and clinical laboratory findings
研究概览
简要总结
This study is designed to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of combination treatment with Temodar®, Genasense®, and Abraxane® in chemotherapy-naïve subjects with advanced melanoma and normal lactate dehydrogenase (LDH).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Subjects with progressive, unresectable, or advanced melanoma who are considered to be candidates for systemic treatment with chemotherapy
- •Subjects will have measurable disease, an Eastern Cooperative Oncology Group Performance Status less than or equal to 2, and serum LDH less than or equal to 1.1 times the upper limit of normal, but will not have previously received cytotoxic chemotherapy
- •Prior immunotherapy, radiotherapy, or cytokine, biologic, or vaccine therapy is permitted in the adjuvant and/or metastatic setting
排除标准
- •Prior treatment with cytotoxic chemotherapy, including regional perfusion, or with Genasense®(oblimersen sodium)Injection
- •Nonmeasurable disease only
- •History or presence of brain metastasis or leptomeningeal disease
- •Significant medical disease other than cancer
- •Known human immunodeficiency virus infection
- •Pregnant or lactating
- •Known hypersensitivity to temozolomide, phosphorothioate-containing oligonucleotides, or products containing human albumin
- •Use of any experimental therapy within 3 weeks prior to baseline evaluations, Other anticancer treatment (such as chemotherapy, radiation, or biologic or investigational therapies) while receiving therapy in this study
结局指标
主要结局
Safety based on adverse event reports and clinical laboratory findings
时间窗: During protocol therapy prior to the start of and during each cycle and up to 30 days after last dose of protocol therapy
次要结局
- Incidence of brain metastasis(At the end of each cycle during protocol therapy, with follow-up every 2 months for up to 2 years from date of registration)
- Response rate (including rate of complete response)(At the end of each cycle during protocol therapy, with follow-up every 2 months for up to 2 years from date of registration)
- Duration of response (including the rate of durable response)(At the end of each cycle during protocol therapy, with follow-up every 2 months for up to 2 years from date of registration)
- Correlations of drug concentrations, intracellular Bcl-2 content, and response(Cycle 1)
- Time to disease progression(At the end of each cycle during protocol therapy, with follow-up every 2 months for up to 2 years from date of registration)
- Survival(12,15, and 18 months from date of registration, with follow-up every 2 months for up to 2 years from date of registration)
研究者
研究点 (1)
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