Stage IV Non-Small Cell Lung Cancer Clinical Trial
Official title:
A Phase I/II Study of Entinostat in Combination With 5-Azacytidine in Patients With Recurrent Advanced Non-Small Cell Lung Cancer
This phase I/II trial is studying the side effects and best dose of azacitidine when given together with entinostat and to see how well they work in treating patients with recurrent advanced non-small cell lung cancer. Azacitidine and entinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving azacitidine together with entinostat may kill more tumor cells.
PRIMARY OBJECTIVES:
I. To assess safety, characterize toxicities, and determine the maximum tolerated dose of
5-AZA (azacitidine) with a fixed-dose of entinostat in patients with recurrent advanced
non-small cell lung cancer (NSCLC). (Phase I) II. To determine the objective response rate of
5-AZA and entinostat in patients with recurrent NSCLC. (Phase II)
SECONDARY OBJECTIVES:
I. To determine the pharmacokinetic profile of 5-AZA and entinostat in patients with
recurrent NSCLC.
II. To assess the pharmacodynamic effects of 5-AZA and entinostat on deoxyribonucleic acid
(DNA) methylation, histone acetylation, and gene re-expression in patients with recurrent
NSCLC through analysis of blood, sputum and tissue biopsies.
III. To explore the effect of 5-AZA and entinostat on progression-free and overall survival
in patients with recurrent advanced non-small cell lung cancer.
IV. To explore the differing response rates and progression-free survivals of two schedules
of 5-AZA and entinostat in patients with recurrent advanced non-small cell lung cancer.
OUTLINE: This is a multicenter, phase I, dose-escalation study of azacitidine followed by an
open-label, phase II study.
Patients receive azacitidine subcutaneously (SC) on days 1-6 and 8-10 and entinostat orally
(PO) on days 3 and 10. Treatment repeats every 28 days in the absence of disease progression
or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months.
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