A Phase 2 Study of Dasatinib in Advanced Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Number of Subjects With Objective Response(Partial Response and Complete Response) as Measured by RECIST Criteria
研究概览
简要总结
This phase II trial is studying how well dasatinib works in treating patients with stage III melanoma that cannot be removed by surgery or stage IV melanoma. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
详细描述
PRIMARY OBJECTIVES:
I. Determine the objective response rate in patients with stage III unresectable or stage IV melanoma treated with dasatinib.
II. Determine the progression-free survival of patients treated with this drug.
SECONDARY OBJECTIVES:
I. To assess the expression of targets of Dasatinib prior to treatment by obtaining pre-treatment biopsies or examining paraffin-embedded tissues from previous tumor resections.
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
- •Histologically confirmed stage III unresectable or stage IV melanoma
- •Measurable disease
- •Must have evidence of tumor growth or new lesions within the past 6 months
- •No large pleural effusions
- •No known brain metastases or leptomeningeal metastases
- •Previously treated brain metastases allowed provided there is no requirement for steroids AND no evidence of progression for ≥ 8 weeks after treatment
- •ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%
- •Life expectancy > 3 months
- •WBC ≥ 3,000/mm³
- •Absolute neutrophil count ≥ 1,500/mm³
- •Platelet count ≥ 100,000/mm³
- •Hemoglobin ≥ 9.0 g/dL (transfusions allowed)
- •Bilirubin ≤ 1.5 mg/mL
- •AST and ALT ≤ 2.5 times upper limit of normal (ULN)
- •PT/INR and PTT normal
- •Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min
- •No medical condition that may affect the ability to swallow and retain dasatinib tablets, including any of the following:
- •Gastrointestinal tract disease resulting in an inability to take oral medication
- •Requirement for IV alimentation
- •Prior surgical procedures affecting absorption
- •Active peptic ulcer disease
- •No clinically significant cardiovascular disease, including any of the following:
- •Myocardial infarction or ventricular tachyarrhythmia within the past 6 months
- •Prolonged QTc > 480 msec
- •Major conduction abnormality (unless a cardiac pacemaker is present)
- •No uncontrolled intercurrent illness including, but not limited to, any of the following:
- •Ongoing or active infection
- •History of significant congenital or acquired bleeding disorder, including any of the following:
- •Von Willebrand's disease
- •Antifactor VIII antibodies
- •Dyspnea at rest or with minimal exertion
- •Uncontrolled seizure disorder
- •Psychiatric illness or social situations that would preclude study compliance
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No other active malignancy within the past 3 years except curatively treated stage I malignancies or resected skin carcinomas
- •Recovered from prior therapy
- •Prior adjuvant therapy for stage II or III melanoma allowed
- •No prior cytotoxic therapy for metastatic melanoma
- •No prior dasatinib or other inhibitors of src, bcr-abl, c-Kit, EPHA2, and PDGFRβ
- •No more than 2 prior immunomodulator therapies for metastatic melanoma
- •At least 1 week since prior and no concurrent warfarin or other anticoagulants or medications that inhibit platelet function (including acetylsalicylic acid)
- •At least 1 week since prior and no concurrent steroids or other immunosuppressive agents
- •Concurrent steroids to treat induced pleural effusions allowed
- •At least 3 weeks since prior immunomodulators including, but not limited to, any of the following:
- •Aldesleukin
- •Cancer vaccines
- •T-cell-activating monoclonal antibodies
- •At least 4 weeks since prior radiotherapy
- 另有 9 项未显示
排除标准
- 未提供
研究组 & 干预措施
Treatment (kinase inhibitor therapy)
Patients receive oral dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: dasatinib (Drug)
结局指标
主要结局
Number of Subjects With Objective Response(Partial Response and Complete Response) as Measured by RECIST Criteria
时间窗: After every 8 weeks (or 2 courses), assessed up to 4 weeks after completion of treatment
Only those patients who have measurable disease present at baseline, have received at least one course of therapy, and have had their disease re-evaluated will be considered evaluable for response. A Simon's optimum two-stage design will be used.
Progression-free Survival
时间窗: Time from start treatment to time of progression, assessed up to 6 months
Progression will be evaluated in this study using the new international criteria proposed by the RECIST Committee. A Simon's optimum two-stage design will be used
次要结局
未报告次要终点