NCT00451048已完成2 期
A Phase II Study of Sunitinib Malate (Sutent®; SU11248) in Patients With Intermediate-2 or High-Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Overall Response Rate (Complete Response, Partial Response, or Hematologic Improvement) Defined by the International Working Group Criteria
研究概览
简要总结
This phase II trial is studying how well sunitinib works in treating patients with myelodysplastic syndromes or chronic myelomonocytic leukemia. Sunitinib may stop the growth of abnormal cells by blocking some of the enzymes needed for cell growth.
详细描述
OBJECTIVES:
I. Determine the overall response rate (complete response, partial response, or hematological improvement) in patients with intermediate-2 or high-risk myelodysplastic syndromes or chronic myelomonocytic leukemia treated with sunitinib malate.
II. Determine the duration of response in patients treated with this drug. III. Determine the overall survival of patients treated with this drug. IV. Determine the progression-free survival of patients treated with this drug. V. Determine the time to disease progression in patients treated with this drug.
VI. Determine the toxicity of this drug in these patients.
OUTLINE: This is a multicenter study.
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
- •MDS syndromes meeting 1 of the following: Intermediate-2 disease, high-risk disease (IPSS score>=1.5)
- •CMML: WBC>12,000/mm^3, Intermediate-2 disease with WBC=<12,000/mm^3, high-risk disease (IPSS score>=1.5) with WBC=<12,000/mm^3
- •Patients with insufficient/inadequate metaphases for cytogenetic analysis are eligible if bone marrow blasts are >10% and/or 2-3 cytopenias are present
- •No known brain metastases
- •Life expectancy>12 weeks
- •ECOG PS 0-2/Karnofsky PS 60-100%
- •Calcium=<3.0 mmol/L
- •Bilirubin normal
- •AST and ALT=<2.5 times upper limit of normal
- •Creatinine normal/creatinine clearance>=60 mL/min
排除标准
- •No history of significant ECG abnormalities including but not limited to: ventricular arrhythmias (ventricular tachycardia, ventricular fibrillation>=3 beats in a row); QTc prolongation (i.e.QTc interval>=500msec)
- •No history of allergic reaction to compounds of similar chemical/biological composition to sunitinib malate
- •No NYHA class III-IV congestive heart failure
- •Patients with history of NYHA class II congestive heart failure who are asymptomatic on treatment are eligible
- •No abdominal fistula/G perforation/intraabdominal abscess within past 28 days
- •No serious cardiovascular disease within past 12 months including: cerebrovascular accident or transient ischemic attack, myocardial infarction, cardiac arrhythmia, stable or unstable angina, symptomatic congestive heart failure, coronary or peripheral artery bypass graft or stenting
- •No pulmonary embolism within past 12 months
- •No uncontrolled hypertension (systolic BP>=140 mmHg/diastolic BP>=90 mmHg)
- •No condition impairing ability to swallow/retain sunitinib malate tablets including: GI tract disease resulting in inability to take oral medication, requirement for IV alimentation, prior surgical procedures affecting absorption, active peptic ulcer disease
- •No serious/nonhealing wound, ulcer, or bone fracture
- •No uncontrolled pre-existing thyroid abnormality
- •No concurrent uncontrolled illness including ongoing/active infection
- •No psychiatric illness/social situation that would preclude study participation
- •Not pregnant/nursing
- •Negative pregnancy test
- •Fertile patients must use effective barrier contraception
- •4 weeks since prior major surgery
- •Prior central thoracic radiotherapy that included heart in radiotherapy port allowed provided NYHA congestive heart failure=<class II
- •Prior anthracycline exposure allowed provided NYHA congestive heart failure=<class II
- •No other prior therapy for MDS/CMML except epoetin alfa, darbepoetin alfa, filgrastim or sargramostim
- •At least 2 weeks since prior epoetin alfa
- •At least 4 weeks since prior darbepoetin alfa
- •No other prior antiangiogenic agents including but not limited to: bevacizumab, sorafenib tosylate, pazopanib hydrochloride, AZD2171, vatalanib, VEGF Trap
- •More than 7 days since prior and no concurrent potent CYP3A4 inhibitors
- •More than 12 days since prior and no concurrent potent CYP3A4 inducers including: Rifampin, Rifabutin, Carbamazepine, Phenobarbital, Phenytoin, Hypericum perforatum, Efavirenz, Tipranavir
- •No concurrent birth control patch/oral birth control pills/depot/injectable birth control methods
- •No concurrent therapeutic coumarin-derivative anticoagulants
- •Low dose(=<2mg) warfarin for prophylaxis of thrombosis allowed
- •Low molecular weight heparin allowed if INR=<1.5
- •No concurrent agents with proarrhythmic potential including: Terfenadine, Quinidine, Procainamide, Disopyramide, Sotalol, Probucol, Bepridil, Haloperidol, Risperidone, Indapamide, Flecainide acetate
- •No concurrent combination antiretroviral therapy for HIV-positive patients
- •No other concurrent investigational agents
研究组 & 干预措施
Arm I
Experimental
Patients will receive sunitinib malate (SU11248) by mouth once a day. Treatment may continue for as long as benefit is shown.
干预措施: sunitinib malate (Drug)
结局指标
主要结局
Overall Response Rate (Complete Response, Partial Response, or Hematologic Improvement) Defined by the International Working Group Criteria
时间窗: Up to 6 years
次要结局
- Progression-free Survival(At 6 months and 1 year)
- Time to Progression(At 6 months and 1 year)
- Number Participants With Complete, Partial or Hematologic Improvement Response(Up to 6 years)
- Highest Severity of Observed Adverse Events Assessed by Common Terminology Criteria or Adverse Events Version 3.0 (CTCAE v3.0)(Up to 6 years)
- Overall Survival(At 6 months and 1 year)
研究者
研究点 (4)
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