NCT01092585Unknown2 期
A Phase II Study of Tesetaxel as Second-line Therapy for Subjects With Advanced Melanoma and Normal Serum LDH
Genta Incorporated2 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2010年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Response rate (RECIST)
研究概览
简要总结
Tesetaxel is an orally administered chemotherapy agent of the taxane class. This study is being undertaken to evaluate the efficacy and safety of tesetaxel administered as second-line therapy to patients with advanced melanoma and normal serum lactate dehydrogenase (LDH).
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
- •Primary inclusion criteria:
- •Histologically confirmed diagnosis of melanoma
- •Progressive disease that is not surgically resectable, or metastatic Stage IV disease
- •Measurable disease (revised RECIST; Version 1.1)
- •Serum LDH not more than 1.1 times the upper limit of normal
- •Eastern Cooperative Oncology Group performance status 0 or 1
- •Treatment with 1 prior regimen (including cytotoxic chemotherapy, immunotherapy, radiation therapy, or cytokine, biologic, or vaccine therapy) as first-line treatment for metastatic disease (Administration of interleukin-2 or interferon as adjuvant therapy is allowed and is not to be considered in determining the 1 prior treatment regimen administered as first-line treatment for metastatic disease.)
- •Adequate bone marrow, hepatic, and renal function, as specified in the protocol
- •At least 3 weeks and recovery from effects of prior surgery or other therapy with an approved or investigational agent
- •Ability to swallow an oral solid-dosage form of medication
排除标准
- •History or presence of brain metastasis or leptomeningeal disease
- •Primary ocular or mucosal melanoma
- •Significant medical disease other than cancer
- •Organ allograft
- •Presence of neuropathy > Grade 1 (National Cancer Institute Common Toxicity Criteria [NCI CTC]; Version 4.0)
- •Prior treatment with a taxane or other tubulin-targeted agent (eg, indibulin) other than a vinca alkaloid
- •Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A pathway or P-glycoprotein activity
结局指标
主要结局
Response rate (RECIST)
时间窗: 12 months from date of first dose of study medication
次要结局
- Proportion of patients with a confirmed complete or partial response at least 3 months in duration(12 months from date of first dose of study medication)
- Disease control rate (ie, the proportion of patients with a confirmed complete or partial response of any duration or stable disease at least 3 months in duration)(12 months from date of first dose of study medication)
- Durable response rate (ie, the proportion of patients with a confirmed complete or partial response at least 6 months in duration)(12 months from date of first dose of study medication)
- Duration of response(12 months from date of first dose of study medication)
- Adverse events(Through 30 days post last dose of study medication)
研究者
研究点 (2)
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