Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00387465
Status:
COMPLETED
Last Update Posted:
2019-05-09
First Post:
2006-10-12
Brief Title:
Azacitidine and Entinostat in Treating Patients With Recurrent Advanced Non-Small Cell Lung Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Study of Entinostat in Combination With 5-Azacytidine in Patients With Recurrent Advanced Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase III 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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01CA070095 | NIH | CTEP | httpsreporternihgovquickSearchU01CA070095 |
| NCI-2009-00220 | REGISTRY | None | None |
| CDR0000504083 | OTHER | None | None |
| NA_00003114 | OTHER | None | None |
| J0658 | OTHER | None | None |
| 7759 | OTHER | None | None |
| P30CA006973 | NIH | None | None |