A Phase I Dose Finding Study of the Pan-DAC Inhibitor Panobinostat (LBH589) in Combination With Etoposide and Cisplatin in the First Line Treatment of Extensive-Stage Small Cell Lung Cancer - An ICORG In-House Study
- To determine the maximum-tolerated dose, the recommended dose, and the activity of
panobinostat when given in combination with etoposide and cisplatin to patients with
extensive-stage small cell lung cancer.
- To estimate the time-to-progression, the duration of response, and disease
stabilization in these patients.
- To estimate the overall survival of these patients.
- To determine the pharmacokinetic profile of panobinostat in combination with etoposide
- To assess the overall safety profile of panobinostat in these patients.
- To determine the adverse events in these patients treated with this regimen.
- To assess the quality of life of these patients.
OUTLINE: This is a multicenter, dose-escalation study of panobinostat.
Patients receive chemotherapy comprising cisplatin IV on day 1, etoposide IV on days 1-3,
and panobinostat IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks for up
to 6 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and then periodically during study treatment and
follow up, using questionnaire EQ-5D (Euro QoL).
Blood samples may be collected at baseline and periodically during and after study treatment
for pharmacokinetic assessment and biomarker translational studies.
After completion of study treatment, patients are followed up at 4 weeks and then every 3
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum-tolerated dose (MTD) and recommended dose (RD)
Galway University Hospital
Ireland: Irish Medicines Board