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

• Conditions: SCLC is the most aggressive and lethal form of lung cancer, typically verysensitive to cytotoxic therapy when first diagnosed, but associated with ahigh incidence of tumour relapse and a very poor life expectancy. Despite the high response rate, approximately 80% of patients with limited disease and nearly all patients with extended disease develop disease relapse or progression.; MedDRA version: 9.1Level: LLTClassification code 10041067Term: Small cell lung cancer

• Registration Number: EUCTR2007-007139-26-DE
• Lead Sponsor: Southern Europe New Drug Organization (SENDO)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02-11
• Last Update Posted: 19 March 2012

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 modified 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 = 50 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
- 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, 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)
- Any other case of current abnormal cardiac functionality or history of cardiac
disease causing LVEF < 45% as determined by ECHO
· 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, or drugs that prolong the QT
interval and/or induce torsades de pointes ventricular arrythmia, 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified