Dasatinib in Treating Patients With Stage III Melanoma That Cannot Be Removed By Surgery or Stage IV Melanoma
A Phase 2 Study of Dasatinib in Advanced Melanoma
研究概览
详细说明
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.
II. In selected patients (approximately 5-10) where tumor tissue is available pre-treatment and can be obtained post-treatment with Dasatinib (21 days after initiation of therapy), to determine if Dasatinib induces changes in expression of selected targets and downstream mediators, including MEK, ERK and RSK-1.
III. To assess toxicity.
OUTLINE:
Patients receive oral dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 4 weeks.
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Connecticut
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New Haven、Connecticut、美国、06520
- Yale University
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Minnesota
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Minneapolis、Minnesota、美国、55455
- Masonic Cancer Center, University of Minnesota
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
- Prior palliative radiotherapy to a single site of disease allowed (tumor is not considered evaluable for response unless there is tumor progression at the site of radiation)
- More than 7 days since prior and no concurrent CYP3A4 inhibitors
- At least 7 days since prior and no concurrent agents with proarrhythmic potential
- No other concurrent investigational agents
- No other concurrent anticancer agents or therapies
- No concurrent enzyme-inducing anticonvulsant agents
- No concurrent grapefruit or grapefruit juice
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No concurrent CYP3A4 inducers
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的: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.
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其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Number of Subjects With Objective Response(Partial Response and Complete Response) as Measured by RECIST Criteria
大体时间:After every 8 weeks (or 2 courses), assessed up to 4 weeks after completion of treatment
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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.
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After every 8 weeks (or 2 courses), assessed up to 4 weeks after completion of treatment
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Progression-free Survival
大体时间:Time from start treatment to time of progression, assessed up to 6 months
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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
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Time from start treatment to time of progression, assessed up to 6 months
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合作者和调查者
调查人员
- 首席研究员:Harriet Kluger、Yale University
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- NCI-2009-00219 (注册表标识符:CTRP (Clinical Trial Reporting Program))
- CDR0000528937
- UMN-2007UC009
- YALE-HIC-0608001765
- HIC#0608001765 (其他标识符:Yale University)
- 7758 (其他标识符:CTEP)
- P30CA016359 (美国 NIH 拨款/合同)
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