Status:
COMPLETED
LBH Phase II in Small Cell Lung Cancer (SCLC)
Lead Sponsor:
Southern Europe New Drug Organization
Collaborating Sponsors:
Novartis Pharmaceuticals
Conditions:
Small Cell Lung Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
SCLC is the most aggressive and lethal form of lung cancer, typically very sensitive to cytotoxic therapy when first diagnosed, but associated with a high incidence of tumour relapse and a very poor l...
Eligibility Criteria
Inclusion
- 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 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 ≥ 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
Exclusion
- 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 (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
- 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 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.
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01222936
Start Date
May 1 2008
End Date
August 1 2010
Last Update
October 18 2010
Active Locations (8)
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1
Klinik für Onkologie und Haematologie
Frankfurt am Main, Germany, 60488
2
Klinikum Kassel Innere Medizin
Kassel, Germany, 34125
3
Azienda Ospedaliera "S. G. Moscati"
Avellino, AV, Italy, 83100
4
Istituto Nazionale Ricerca sul Cancro
Genova, GE, Italy, 16132