NCT00180830终止2 期
Open Label, Pilot Phase II Study of Glivec in Children and Adolescents With Life Threatening Diseases Known to Be Associated With One or More Glivec-Sensitive Tyrosine Kinases
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 36
- 试验地点
- 6
- 主要终点
- - Tumour Response
研究概览
简要总结
The purpose of this study is to determine whether Glivec is effective, in children, adolescents and young adults, in the treatment of malignant disease in which evidence suggests a potential pathogenic role of one or more of the tyrosine kinases known to be inhibited by Glivec.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients from 6 months to 21 years of age.
- •Malignant disease documented by conventional criteria to be refractory to standard, approved therapy, or for which no conventional therapies of definitive benefit exist.
- •Immunohistochemistry documentation of positivity of either Kit (CD117) or PDGF-R in tumor tissue relevant. Each positive tumor will be centrally reviewed before inclusion of the patient in the trial.
- •Measurable or evaluable disease.
- •WHO Performance status 0,1, or 2 or Lansky Play Scale >= 50%.
- •Adequate organ function, defined as the following: total bilirubin < 1.5 x ULN, SGOT and SGPT < 2.5 x UNL (or < 5 x ULN if hepatic disease involvement is present), creatinine < 1.5 x ULN, ANC > 1x 109/L, platelets > 75 x 109/L.
- •Female patients of child-bearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing.
- •Male and female patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug.
- •Life expectancy of more than 6 weeks.
- •Written, voluntary, informed consent, including consent for retrieval and investigational use of tissue samples for evaluation signed by parents or young adult patients.
- •National and, when needed, local ethical approval.
排除标准
- •Patient with hematological disease positive for the chimeric BCR-ABL fusion protein or for c-kit.
- •Patient has received any other investigational agents within 28 days of first day of study drug dosing.
- •Female patients who are pregnant or breast-feeding.
- •Patient has another severe and/or life-threatening medical diseasePatient has an acute or known chronic liver disease (e.g., chronic active hepatitis, cirrhosis).
- •Patient has a known diagnosis of human immunodeficiency virus (HIV) infection.
- •Patient has received chemotherapy within 4 weeks (6 weeks for nitrosourea, mitomycin-C or any antibody therapy) prior to study entry unless urgent enrollment needed and approved by the study coordinator.
结局指标
主要结局
- Tumour Response
次要结局
- Progression-free Survival, overall Survival, safety and tolerability, pharmacokinetic profile and pharmacodynamics of Glivec, pharmacogenetics
研究者
研究点 (6)
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