A Phase II Trial of Dasatinib in KIT-Positive Patients With Unresectable Locally Advanced or Stage IV Mucosal, Acral and Vulvovaginal Melanomas
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 151
- 主要终点
- Objective Response Rate Among KIT-positive Patients
研究概览
简要总结
RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well dasatinib works in treating patients with locally advanced or metastatic mucosal melanoma or acral melanoma.
详细描述
OBJECTIVES:
Primary
- To estimate the objective tumor response rate in patients with KIT-positive, unresectable, locally advanced or metastatic acral or mucosal melanoma treated with dasatinib monotherapy.
Secondary
- To estimate the response duration in patients treated with this drug.
- To estimate the progression-free survival of patients treated with this drug.
- To evaluate the safety profile of this drug in these patients.
- To evaluate the PDGFR expression and activation of Src family kinases in tumor samples and correlate these parameters with response to treatment.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Dasatinib
Patients receive oral dasatinib at 70 mg twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: dasatinib (Drug)
结局指标
主要结局
Objective Response Rate Among KIT-positive Patients
时间窗: Every 6 weeks; up to 5 years
Objective response is defined as complete response (CR) or partial response (PR) per Solid Tumor Response Criteria (RECIST). Complete response is defined as disappearance of all target and non-target lesions. Partial response is defined as at least 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter.
次要结局
- Duration of Response for Dasatinib Monotherapy in This Patient Population(Every 6 weeks; up to 5 years)
- Progression-free Survival(Every 6 weeks; up to 5 years)