Clinical trial NCT01222936 (phase 2, status: completed)
Conditions: small cell lung carcinoma
ICD codes: D02.20, D02.21, D02.22
Drugs: lbh581
SMILES: [H]\C(=C(\[H])C1=CC=C(CNCCC2=C(C)NC3=CC=CC=C23)C=C1)C(O)=NO
Eligibility criteria:

        Inclusion Criteria:

          1. Histological/cytological diagnosis of SCLC, mixed small and non small cell tumours are
             excluded

          2. ≤ 2 prior chemotherapy lines

          3. Progression after, and not during, last previous chemotherapy treatment

          4. Age ≥ 18 and ≤ 75 years

          5. Life expectancy of at least 3 months

          6. ECOG Performance Status 0-1

          7. 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 lesion, histological confirmation is not
             required.

          8. Adequate haematological function:

               -  haemoglobin ≥ 9 g/dl

               -  platelet count ≥ 100,000/mm3

               -  neutrophils count ≥ 1,500/mm3

          9. 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

         10. Fertile patients must use effective contraception during and for ≥ 6 weeks after
             completion of study therapy

         11. Ability to signed informed consent

        Exclusion Criteria:

          1. Progression while on previous chemotherapy

          2. Other chemotherapy treatment < 4 weeks prior to enrolment

          3. Presence of active infection

          4. A known history of HIV positivity

          5. Participation to any investigational drug study < 4 weeks preceding study enrolment

          6. Radiotherapy involving > 30% of the active bone marrow

          7. Thoracic and brain radiotherapy < 4 weeks prior to enrolment. Palliative radiotherapy
             is allowed during study treatment

          8. Presence of any serious neurological or psychiatric disorder

          9. 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 (biphasic block)

               -  Acute MI ≤ 3 months prior to starting study drug

               -  Other clinically significant heart disease (e.g. congestive heart failure,
                  previous history angina pectoris, 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

         10. Known hypersensitivity/allergic reaction to the study product

         11. 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.

         12. 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.

         13. Symptomatic or progressive brain metastases

         14. 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

         15. Pregnant or lactating women

         16. Concomitant use of CYP3A4/5 inhibitors or inducers, or drug that prolong the QT
             interval and/or induce torsades ventricular arrythmia, where the treatment can not be
             discontinued or switched to a different medication prior to starting study drug.

         17. Treatment with any hematopoietic colony-stimulating growth factors (e.g., G-CSF,
             GMCSF) ≤ 2 weeks prior to starting study drug.

         18. Unable or unwilling to comply with all study procedures