CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 94 enrolled
Drug / intervention
Azacitidine 30mg/m2 +2 moredrug
Likely dose
Azacitidine 30mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00387465
NCT00387465Phase 2Completed
CompareCT.gov

A Phase I/II Study of Entinostat in Combination With 5-Azacytidine in Patients With Recurrent Advanced Non-Small Cell Lung Cancer

National Cancer Institute (NCI)·interventional·Posted Oct 13, 2006·Updated May 9, 2019

In Brief

A Phase 2 clinical trial evaluating Azacitidine 30mg/m2, Entinostat, and 1 other intervention for Recurrent Non-Small Cell Lung Carcinoma and 3 related conditions. Completed, enrolled 94 participants across 5 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRecurrent Non-Small Cell Lung Carcinoma, Stage IIIA Non-Small Cell Lung Cancer, Stage IIIB Non-Small Cell Lung Cancer, Stage IV Non-Small Cell Lung Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 13, 2006
Enrollment StartAug 1, 2006
Primary CompletionMay 1, 2014
Study CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 7.8 yearsPosted 19.7 years ago

Interventions

Azacitidine 30mg/m2drug

Azacitidine 30mg/m2 subcutaneously (SQ)

Entinostatdrug

7mg by mouth (PO) on days 3 and 10 of each cycle

Azacitidine 40mg/m2drug

Azacitidine 40mg/m2 SQ