EUCTR2007-005684-10-DE进行中（未招募）不适用
An open Phase I/IIa trial to investigate the maximum tolerated dose, safety, efficacy and pharmacokinetics of BI 811283 in combination with cytarabine in patients with previously untreated acute myeloid leukaemia ineligible for intensive treatment
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 169
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
- •For the phase I part: male or female adult with previously untreated AML (except hydroxyurea, see protocol section 4.2.2) or relapsed/refractory AML. For the phase IIa part: male or female adult with previously untreated AML (except hydroxyurea, see protocol section 4.2.2)
- •Confirmed diagnosis of AML according to the WHO definition (except for acute
- •promyelocytic leukaemia, APL)
- •Patient is considered ineligible for intensive treatment
- •Patient is eligible for LD-Ara-C treatment
- •Life expectancy = 3 months
- •Eastern co-operative oncology group (ECOG, R01-0787) performance score = 2 at
- •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 APL (AML subtype M3 according to the French-American-British
- •(FAB) classification)
- •Relapsed or treatment refractory AML (for phase II part only)
- •Hypersensitivity to one of the trial drugs or the excipients
- •Other malignancy requiring treatment
- •Known central nervous system involvement
- •Aspartate amino transferase (AST) or alanine amino transferase (ALT) greater than
- •2.5 times the upper limit of normal
- •INR > 1.5 x ULN for subjects not on therapeutic vitamin K antagonists
- •(phenprocoumon, warfarin)
- •Bilirubin greater than 1.5 mg/dl (> 26 µmol/l, SI unit equivalent)
- •Serum creatinine greater than 2.0 mg/dl
- •LVEF (Left ventricular ejection fraction) < 50% in echocardiography or clinical
- •congestive heart failure New York Heart Association (NYHA) grade III - IV
- •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 (i.e. other chemo- or immunotherapy)
- •Contraindications for cytarabine treatment according to the summary of product
- •characteristics (SPC)
- •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.)
- •Pregnant or nursing female patients
- •Patient unable to comply with the protocol
研究者
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