EUCTR2007-007139-26-GR进行中（未招募）1 期
A phase II study of the histone deacetylase inhibitor Panobinostat (LBH589) in patients with advanced Small Cell Lung Cancer (SCLC)
Southern Europe New Drug Organization (SENDO)0 个研究点目标入组 48 人开始时间: 2009年2月20日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 48
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
- •· Histological/cytological diagnosis of SCLC, mixed small and non small
- •cell tumours are excluded
- •· = 2 prior chemotherapy lines
- •· Progression after, and not during, last previous chemotherapy treatment
- •· Age = 18 and = 75 years
- •· Life expectancy of at least 3 months
- •· ECOG Performance Status 0-1
- •· At least one measurable lesion according to RECIST criteria: defined as
- •= 1 lesion with longest diameter = 20 mm by conventional techniques or
- •= 10 mm with spiral CT scan. In case of solitary measurable leasion
- •histological confirmation is not required.
- •· Adequate haematological function:
- •- haemoglobin = 9 g/dl
- •- platelet count = 100,000/mm3
- •- neutrophils count = 1,500/mm3
- •· Adequate liver and renal functions:
- •- Total serum bilirubin = 1.5 x UNL
- •- Serum creatinine = 1.5 x UNL or 24 hours creatinine clearance = 60 mL/min
- •- AST and ALT = 2.5 x UNL or = 5.0 x UNL if the transaminase
- •elevation is due to hepatic involvement
- •- Albumin = 2.5 g/dl
- •- Alkaline phosphatase = 2.5 x UNL
- •· Fertile patients must use effective contraception during and for = 6 weeks
- •after completion of study therapy
- •· Ability to signed informed consent
- •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
- •· Progression while on previous chemotherapy
- •· Other chemotherapy treatment < 4 weeks prior to enrolment
- •· Presence of active infection
- •· A known history of HIV positivity
- •· Participation to any investigational drug study < 4 weeks preceding study
- •· Radiotherapy involving > 30% of the active bone marrow
- •· Thoracic and brain radiotherapy < 4 weeks prior to enrolment. Palliative
- •radiotherapy is allowed during study treatment
- •· Presence of any serious neurological or psychiatric disorder
- •· Impaired cardiac function, including any one of the following:
- •- Cardiac - LVEF < 45% as determined by ECHO
- •- Complete Left Bundle Branch Block or obligate use of a cardiac
- •pacemaker or congenital long QT syndrome or history or presence of
- •atrial or ventricular tachyarrhythmias or clinically significant resting
- •bradycardia (< 50 beats per minute) or QTcF > 480 msec on screening
- •ECG or Right Bundle Branch block + left anterior hemiblock
- •(bifasicular block)
- •- Other clinically significant heart disease (e.g. congestive heart failure,
- •angina pectoris angina pectoris, myocardial infarction within = 3
- •months prior to starting study drug, uncontrolled hypertension, history
- •of labile hypertension or arrhythmia, or history of poor compliance with
- •an antihypertensive regimen)
- •· Known hypersensitivity/allergic reaction to the study product
- •· Presence of uncontrolled intercurrent illness or any condition which in the
- •judgement of the investigator would place the subject at undue risk or
- •interfere with the results of the study.
- •· Previous or current concomitant malignancy at other site, other than
- •basal or squamous cell carcinoma of the skin and carcinoma in situ of the uterine
- •cervix, within 3 years
- •· Symptomatic or progressive brain metastases
- •· Patients with an active bleeding diathesis or on anticoagulants.
- •Therapeutic doses of sodium warfarin (Coumadin) are not allowed. Low
- •doses of Coumadin (e.g., = 2 mg/day) for line patency are allowed
- •· Pregnant or lactating women
- •· Concomitant use of CYP3A4/5 inhibitors or inducers where the treatment
- •can not be discontinued or switched to a different medication prior to
- •starting study drug (medications listed in the following web site
- •http://medicine.iupui.edu/flockhart/table.htm).
- •· Treatment with any hematopoietic colony-stimulating growth factors (e.g.,
- •G-CSF, GMCSF) = 2 weeks prior to starting study drug.
- •· Unable or unwilling to comply with all study procedures
研究者
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