Trial Outcomes & Findings for Azacitidine and Entinostat in Treating Patients With Stage I Non-Small Cell Lung Cancer That Has Been Removed By Surgery (NCT NCT01207726)
NCT ID: NCT01207726
Last Updated: 2019-02-05
Results Overview
The DFS hazard rate and 95% confidence interval will be reported. At this time, event time distributions for disease-free survival in the two arms will be estimated with the method of Kaplan and Meier and compared using a stratified Cox-proportional hazards model (stratified for stage IA vs IB) with a two-sided alpha of 10%.
TERMINATED
PHASE2
13 participants
3 years
2019-02-05
Participant Flow
Participant milestones
| Measure |
Azacitidine SC and Entinostat Oral
Patients receive azacitidine SC on days 1-5 and 8-10 and entinostat PO QD on days 3 and 10. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
|
Chemotherapy Alone
Standard of care chemotherapy
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
6
|
|
Overall Study
COMPLETED
|
7
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study stopped due to early stopping rule
Baseline characteristics by cohort
| Measure |
Azacitidine SC and Entinostat PO
n=7 Participants
Patients receive azacitidine SC on days 1-5 and 8-10 and entinostat PO QD on days 3 and 10. Followed by Cytotoxic Therapy investigator Choice
|
Cytotoxic Therapy
n=6 Participants
Standard of care
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants • Study stopped due to early stopping rule
|
0 Participants
n=4 Participants • Study stopped due to early stopping rule
|
0 Participants
n=27 Participants • Study stopped due to early stopping rule
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=93 Participants • Study stopped due to early stopping rule
|
1 Participants
n=4 Participants • Study stopped due to early stopping rule
|
5 Participants
n=27 Participants • Study stopped due to early stopping rule
|
|
Age, Categorical
>=65 years
|
3 Participants
n=93 Participants • Study stopped due to early stopping rule
|
5 Participants
n=4 Participants • Study stopped due to early stopping rule
|
8 Participants
n=27 Participants • Study stopped due to early stopping rule
|
|
Age, Continuous
|
66 years
n=93 Participants
|
68 years
n=4 Participants
|
67 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=93 Participants
|
6 participants
n=4 Participants
|
13 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: The study was terminated early due to poor accrual since the requirement of clinic administration of the 5AZA daily and post-operative patients not wanting 6 months of treatment. Data was not collected to assess this outcome measure.
The DFS hazard rate and 95% confidence interval will be reported. At this time, event time distributions for disease-free survival in the two arms will be estimated with the method of Kaplan and Meier and compared using a stratified Cox-proportional hazards model (stratified for stage IA vs IB) with a two-sided alpha of 10%.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: The study was terminated early due to poor accrual since the requirement of clinic administration of the 5AZA daily and post-operative patients not wanting 6 months of treatment. Data was not collected to assess this outcome measure.
The study was terminated early due to poor accrual since the requirement of clinic administration of the 5AZA daily and post-operative patients not wanting 6 months of treatment. For this reason, 13 pts were enrolled and data was not analyzed, for which we are unable to make any conclusions or report results.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: The study was terminated early due to poor accrual since the requirement of clinic administration of the 5AZA daily and post-operative patients not wanting 6 months of treatment. Data was not collected to assess this outcome measure.
Determined by the method determined by Kaplan and Meier. Estimated with 95% confidence intervals. Cox proportional hazard modeling will be used for multivariate analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: The study was terminated early due to poor accrual since the requirement of clinic administration of the 5AZA daily and post-operative patients not wanting 6 months of treatment. Data was not collected to assess this outcome measure.
Kaplan Meier curves will be used.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: The study was terminated early due to poor accrual since the requirement of clinic administration of the 5AZA daily and post-operative patients not wanting 6 months of treatment. Data was not collected to assess this outcome measure.
Determined by the method determined by Kaplan and Meier. Estimated with 95% confidence intervals. Cox proportional hazard modeling will be used for multivariate analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: The study was terminated early due to poor accrual since the requirement of clinic administration of the 5AZA daily and post-operative patients not wanting 6 months of treatment. Data was not collected to assess this outcome measure.
McNemar's test will be used to compare the change in methylation after treatment in sputum.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: The study was terminated early due to poor accrual since the requirement of clinic administration of the 5AZA daily and post-operative patients not wanting 6 months of treatment. Data was not collected to assess this outcome measure.
Simple descriptive statistics will be utilized to display the data.
Outcome measures
Outcome data not reported
Adverse Events
Azacitidine SC and Entinostat PO
Cytotoxic Chemotherapy
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60