SCLC patients MedDRA version: 9.1 Level: LLT Classification code 10041070 Term: Small cell lung cancer recurrent
Conditions
Interventions
Product Name: Panobinostat
Product Code: LBH589
Pharmaceutical Form: Solution for infusion
Current Sponsor code: LBH589
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: .0
Sponsors
SENDO TECH
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: Progression while on previous chemotherapy Other chemotherapy treatment 30% of the active bone marrow Thoracic and brain radiotherapy 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 To assess the safety profile;Primary end point(s): Objective response rate measured according to the RECIST criteria. | — |
Countries
Germany, Italy
Outcome results
None listed