EUCTR2006-000613-38-DE进行中（未招募）不适用
An open, randomised clinical Phase I/IIa trial to investigate the maximum tolerated dose, efficacy, safety and pharmacokinetics of repeated three-week courses of a single dose i.v. BI 2536 on day 1 in comparison to single doses i.v. BI 2536 on days 1, 2 and 3 in patients over 60 years of age with refractory or relapsed acute myeloid leukaemia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
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
- •Male or female patients older than 60 years of age
- •Patient with confirmed AML (except for APL) according to the WHO definition who relapsed after or are refractory to prior chemotherapy
- •Leukocyte count = 25,000 /µl (25 x 109/Liter)
- •Patient not eligible for intensive treatment options
- •Life expectancy = 2 months
- •Eastern co-operative oncology group performance score of 2 or less
- •Signed written informed consent consistent with international conference on harmonisation – good clinical practice (ICH-GCP) and local legislation
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patient with acute promyelocytic leukaemia (APL, AML of the French-American-British (FAB) classification subtype M3)
- •Hypersensitivity to the trial drug or the excipients
- •Secondary malignancy requiring therapy
- •Known central nervous system involvement
- •Aspartate amino transferase (AST) or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal, or AST or ALT greater than 5 times the upper limit of normal in case of known liver involvement
- •Bilirubin greater than 1.5 mg/dl (> 26 umol/l, SI unit equivalent)
- •Serum creatinine greater than 2.0 mg/dl
- •Concomitant intercurrent illness, which would compromise the evaluation of efficacy or safety of the trial drug, e.g. active severe infection, unstable angina pectoris or cardiac arrhythmia
- •Psychiatric illness or social situation that would limit compliance with trial requirements
- •Concomitant therapy, which is considered relevant for the evaluation of the efficacy or safety of the trial drug (see also section 4.2.2)
- •Chemotherapy (except hydroxyurea, see section 4.2.2) or immunotherapy within the past two weeks prior to treatment with BI 2536
- •Any other investigational drugs within a period of the drug's half-life x5 prior to treatment with BI 2536
- •Persistence of toxicities of prior anti-leukaemia therapies which are deemed to be clinically relevant
- •Patients who are sexually active and unwilling to use a medically acceptable method of contraception during the trial (hormonal contraception, intrauterine device, condom with spermacide, etc.)
- •Patient unable to comply with the protocol
研究者
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