EUCTR2010-022945-52-Outside-EU/EEA进行中（未招募）不适用
A Phase 1 Study of BMS-354825 (Dasatinib) in Children with Recurrent/Refractory Solid Tumors or Imatinib Resistant Ph+ Leukemia.
Children’s Oncology Group0 个研究点目标入组 40 人开始时间: 2012年1月26日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Greater than 12 months and less than or equal to 21 years of age at the time of study entry
- •2. Histologic verification of solid tumor malignancy at original diagnosis or relapse, or had imatinib resistant Ph+ ALL, or CML. Subjects with tumors of the central nervous system were not eligible.
- •Imatinib resistance in Ph+ CML was defined as any of the following:
- •a. Increasing white blood cell (WBC) or platelet count while on imatinib therapy
- •b. Lack of any cytogenetic response after an adequate duration of imatinib therapy, as defined by failure to achieve a complete hematological response after 3 months of imatinib therapy OR failure to achieve a partial or complete cytogenetic response (ie, = 35% Ph+) after 6 months of imatinib therapy
- •c. Appearance of accelerated or blastic features while on imatinib therapy
- •d. Reappearance of Ph+ clones after an initial complete cytogenetic response to imatinib
- •e. An increase in Ph+ cells of > 30% in peripheral blood or bone marrow cytogenetics while on imatinib therapy
- •f. Imatinib intolerance as defined by development of an AE requiring discontinuation of imatinib therapy
- •3. Solid tumors with measurable or evaluable disease. Leukemia with measurable disease: for subjects with CML, hematologic, cytogenetic, and molecular studies determined measurable disease. For subjects with ALL, bone marrow blast percentage determined measurable disease.
- •4. Current disease state for which there is no known curative therapy or one proven to prolong survival with an acceptable quality of life
- •5. Karnofsky score = 50% for subjects > 10 years of age or Lansky score = 50 for subjects = 10 years of age
- •6. Organ function requirements
- •a. Adequate bone marrow function
- •b. Adequate renal function
- •c. Adequate liver function
- •d. Adequate cardiac function
- •e. Adequate pulmonary function
- •7. Signed subject informed consent
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 38
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 2
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects who met any of the following criteria were excluded from the study.
- •1. Pregnant or breast-feeding.
- •2. Use of the following concomitant medications during the study:
- •a. Growth factors that support the number or function of platelets or white cells within 7 days of study entry
- •b. Another investigational drug
- •c. Other anticancer agents
- •d. Enzyme-inducing anticonvulsants
- •e. Antithrombotic and antiplatelet agents
- •f. Specific CYP3A4 inhibitors
- •3. Uncontrolled infection
- •4. Unable to swallow oral or liquid medication
- •5. Human immunodeficiency virus-positive subjects whose highly active antiretroviral therapy regimen could interact with dasatinib
- •6. Unable, in the opinion of the investigator, to comply with the safety monitoring requirements of the study
研究者
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