EUCTR2007-007139-26-IT进行中（未招募）不适用
A phase II study of the histone deacetylase inhibitor Panobinostat (LBH589) in patients with advanced Small Cell Lung Cancer (SCLC) - ND
SENDO TECH0 个研究点目标入组 48 人开始时间: 2008年4月16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
- 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 lesion 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 enrolment
- •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). The medications listed in Appendix 4 have a relative risk of prolonging the QT interval or inducing Torsades de Pointes, but do not represent an exclusion criterion.
- •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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