E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10041070 |
E.1.2 | Term | Small cell lung cancer recurrent |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
|
E.2.2 | Secondary objectives of the trial |
To assess the duration of antitumor activity To assess the safety profile |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
Objective response rate measured according to the RECIST criteria. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 9 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |