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A Phase II Study of the Histone Deacetylase Inhibitor Panobinostat (LBH589) in Patients With Advanced Small Cell Lung Cancer (SCLC)

Phase 2
18 Years
75 Years
Not Enrolling
Small Cell Lung Carcinoma

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Trial Information

A Phase II Study of the Histone Deacetylase Inhibitor Panobinostat (LBH589) in Patients With Advanced Small Cell Lung Cancer (SCLC)

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate

Outcome Description:

Objective response rate measured according to the RECIST (Response Evaluation Criteria In Solid Tumours).

Outcome Time Frame:

12-18 weeks (foreseen participation of the patient in the study)

Safety Issue:


Principal Investigator

Filippo De Marinis, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Azienda Ospedaliera San Camillo Forlanini


Italy: Ethics Committee

Study ID:




Start Date:

May 2008

Completion Date:

August 2010

Related Keywords:

  • Small Cell Lung Carcinoma
  • LBH581
  • Panobinostat
  • Small Cell Lung Carcinoma
  • Carcinoma
  • Lung Neoplasms
  • Small Cell Lung Carcinoma