A phase II study of the histone deacetylase inhibitor Panobinostat (LBH589) in patients with advanced Small Cell Lung Cancer (SCLC)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 48

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the antitumor activity of LBH589 as single agent given i.v. in patients previously treated with no more than 2 previous chemotherapy lines.;Secondary Objective: To assess the duration of antitumor activity<br>To assess the safety profile;Primary end point(s): Objective response rate measured according to the RECIST criteria.

Secondary Outcome Measures

Name	Time	Method

Related Trials

Southern Europe New Drug Organization (SENDO)

Updated 3/19/2012