Trial Outcomes & Findings for Azacitidine and Entinostat Before Chemotherapy in Treating Patients With Advanced Non-small Cell Lung Cancer (NCT NCT01935947)
NCT ID: NCT01935947
Last Updated: 2018-07-27
Results Overview
The final analysis will be by Fisher's Exact test, with percentage of patients who have not progressed as the outcome variable. Using Fisher's Exact test for analysis with 55 patients per treatment group will provide 88% power to detect an increase from 40% (chemotherapy alone) to 65% (epigenetic therapy followed by chemotherapy) in the number of patients who are progression free at six months.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
At 6 months
Results posted on
2018-07-27
Participant Flow
There were seven screen failures.
Participant milestones
| Measure |
Arm I (Azacitidine, Entinostat, Chemotherapy)
Patients receive azacitidine SC on days 1-6 and 8-10 and entinostat PO on days 3 and 10. Treatment repeats every 28 days for 2 courses, then chemotherapy. Treatment repeats every 21 days.
|
Arm II (Azacitidine, Entinostat, Chemotherapy)
Patients receive azacitidine PO on days 1-21 and entinostat PO on days 3 and 10. Treatment repeats every 28 days for 2 courses. Patients receive chemotherapy of the treating oncologist's choice as in Arm A.
|
Arm III (Chemotherapy)
Patients receive chemotherapy of the treating oncologist's choice as in Arm A.
|
|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
2
|
|
Overall Study
Epigenetic Therapy
|
4
|
4
|
0
|
|
Overall Study
Cytotoxic Therapy
|
3
|
3
|
2
|
|
Overall Study
COMPLETED
|
1
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
2
|
Reasons for withdrawal
| Measure |
Arm I (Azacitidine, Entinostat, Chemotherapy)
Patients receive azacitidine SC on days 1-6 and 8-10 and entinostat PO on days 3 and 10. Treatment repeats every 28 days for 2 courses, then chemotherapy. Treatment repeats every 21 days.
|
Arm II (Azacitidine, Entinostat, Chemotherapy)
Patients receive azacitidine PO on days 1-21 and entinostat PO on days 3 and 10. Treatment repeats every 28 days for 2 courses. Patients receive chemotherapy of the treating oncologist's choice as in Arm A.
|
Arm III (Chemotherapy)
Patients receive chemotherapy of the treating oncologist's choice as in Arm A.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
0
|
|
Overall Study
Diease Progression
|
2
|
2
|
2
|
|
Overall Study
Death
|
1
|
0
|
0
|
Baseline Characteristics
Azacitidine and Entinostat Before Chemotherapy in Treating Patients With Advanced Non-small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Arm I (Azacitidine, Entinostat, Chemotherapy)
n=4 Participants
Patients receive azacitidine SC on days 1-6 and 8-10 and entinostat PO on days 3 and 10. Treatment repeats every 28 days for 2 courses then patients receive chemotherapy. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
|
Arm II (Azacitidine, Entinostat, Chemotherapy)
n=4 Participants
Patients receive azacitidine PO on days 1-21 and entinostat PO on days 3 and 10. Treatment repeats every 28 days for 2 courses, and then patients receive chemotherapy as in Arm A.
|
Arm III (Chemotherapy)
n=2 Participants
Patients receive chemotherapy of the treating oncologist's choice as in Arm A.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Age, Continuous
|
63 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
62 years
STANDARD_DEVIATION 8.4 • n=7 Participants
|
54 years
STANDARD_DEVIATION 2.0 • n=5 Participants
|
60 years
STANDARD_DEVIATION 4.0 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
2 participants
n=5 Participants
|
10 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At 6 monthsPopulation: Data was not collected to assess this outcome measure due to early study termination.
The final analysis will be by Fisher's Exact test, with percentage of patients who have not progressed as the outcome variable. Using Fisher's Exact test for analysis with 55 patients per treatment group will provide 88% power to detect an increase from 40% (chemotherapy alone) to 65% (epigenetic therapy followed by chemotherapy) in the number of patients who are progression free at six months.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the time of enrollment to trial until death, assessed up to 2 yearsPopulation: Data was not collected to assess this outcome measure due to early study termination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 2 yearsPopulation: Data was not collected to assess this outcome measure due to early study termination.
From the time of randomization until radiologic or clinical progression is noted, assessed up to 2 years.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: After 1 month of therapyPopulation: Data was not collected to assess this outcome measure due to early study termination.
Expression array and methylation array will be compared to response.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: After 1 month of therapyPopulation: Data was not collected to assess this outcome measure due to early study termination.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: After 1 month of therapyPopulation: Data was not collected to assess this outcome measure due to early study termination.
Outcome measures
Outcome data not reported
Adverse Events
Arm I (Azacitidine, Entinostat, Chemotherapy)
Serious events: 2 serious events
Other events: 4 other events
Deaths: 1 deaths
Arm II (Azacitidine, Entinostat, Chemotherapy)
Serious events: 4 serious events
Other events: 4 other events
Deaths: 1 deaths
Arm III (Chemotherapy)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (Azacitidine, Entinostat, Chemotherapy)
n=4 participants at risk
Patients receive azacitidine SC on days 1-6 and 8-10 and entinostat PO on days 3 and 10. Treatment repeats every 28 days for 2 course, and then receive chemotherapy. Treatment repeats every 21 days.
|
Arm II (Azacitidine, Entinostat, Chemotherapy)
n=4 participants at risk
Patients receive azacitidine PO on days 1-21 and entinostat PO on days 3 and 10. Treatment repeats every 28 days for 2 courses, and then receive chemotherapy as in Arm A.
|
Arm III (Chemotherapy)
n=2 participants at risk
Patients receive chemotherapy as in Arm A.
|
|---|---|---|---|
|
Eye disorders
Blurred Vision
|
25.0%
1/4 • Number of events 1 • up to 2 years
Adverse events and serious adverse events will be collected for up to 30 days after the last administration of the investigational agent/intervention
|
0.00%
0/4 • up to 2 years
Adverse events and serious adverse events will be collected for up to 30 days after the last administration of the investigational agent/intervention
|
0.00%
0/2 • up to 2 years
Adverse events and serious adverse events will be collected for up to 30 days after the last administration of the investigational agent/intervention
|
|
Nervous system disorders
Spinal Cord Depression
|
0.00%
0/4 • up to 2 years
Adverse events and serious adverse events will be collected for up to 30 days after the last administration of the investigational agent/intervention
|
25.0%
1/4 • Number of events 1 • up to 2 years
Adverse events and serious adverse events will be collected for up to 30 days after the last administration of the investigational agent/intervention
|
0.00%
0/2 • up to 2 years
Adverse events and serious adverse events will be collected for up to 30 days after the last administration of the investigational agent/intervention
|
|
Musculoskeletal and connective tissue disorders
Dysphagia
|
0.00%
0/4 • up to 2 years
Adverse events and serious adverse events will be collected for up to 30 days after the last administration of the investigational agent/intervention
|
25.0%
1/4 • Number of events 1 • up to 2 years
Adverse events and serious adverse events will be collected for up to 30 days after the last administration of the investigational agent/intervention
|
50.0%
1/2 • Number of events 1 • up to 2 years
Adverse events and serious adverse events will be collected for up to 30 days after the last administration of the investigational agent/intervention
|
|
Psychiatric disorders
Confusion
|
0.00%
0/4 • up to 2 years
Adverse events and serious adverse events will be collected for up to 30 days after the last administration of the investigational agent/intervention
|
25.0%
1/4 • Number of events 2 • up to 2 years
Adverse events and serious adverse events will be collected for up to 30 days after the last administration of the investigational agent/intervention
|
0.00%
0/2 • up to 2 years
Adverse events and serious adverse events will be collected for up to 30 days after the last administration of the investigational agent/intervention
|
|
Respiratory, thoracic and mediastinal disorders
Lung Infection
|
25.0%
1/4 • Number of events 1 • up to 2 years
Adverse events and serious adverse events will be collected for up to 30 days after the last administration of the investigational agent/intervention
|
0.00%
0/4 • up to 2 years
Adverse events and serious adverse events will be collected for up to 30 days after the last administration of the investigational agent/intervention
|
0.00%
0/2 • up to 2 years
Adverse events and serious adverse events will be collected for up to 30 days after the last administration of the investigational agent/intervention
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
25.0%
1/4 • Number of events 4 • up to 2 years
Adverse events and serious adverse events will be collected for up to 30 days after the last administration of the investigational agent/intervention
|
25.0%
1/4 • Number of events 2 • up to 2 years
Adverse events and serious adverse events will be collected for up to 30 days after the last administration of the investigational agent/intervention
|
0.00%
0/2 • up to 2 years
Adverse events and serious adverse events will be collected for up to 30 days after the last administration of the investigational agent/intervention
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
50.0%
2/4 • Number of events 3 • up to 2 years
Adverse events and serious adverse events will be collected for up to 30 days after the last administration of the investigational agent/intervention
|
50.0%
2/4 • Number of events 2 • up to 2 years
Adverse events and serious adverse events will be collected for up to 30 days after the last administration of the investigational agent/intervention
|
50.0%
1/2 • Number of events 2 • up to 2 years
Adverse events and serious adverse events will be collected for up to 30 days after the last administration of the investigational agent/intervention
|
Other adverse events
| Measure |
Arm I (Azacitidine, Entinostat, Chemotherapy)
n=4 participants at risk
Patients receive azacitidine SC on days 1-6 and 8-10 and entinostat PO on days 3 and 10. Treatment repeats every 28 days for 2 course, and then receive chemotherapy. Treatment repeats every 21 days.
|
Arm II (Azacitidine, Entinostat, Chemotherapy)
n=4 participants at risk
Patients receive azacitidine PO on days 1-21 and entinostat PO on days 3 and 10. Treatment repeats every 28 days for 2 courses, and then receive chemotherapy as in Arm A.
|
Arm III (Chemotherapy)
n=2 participants at risk
Patients receive chemotherapy as in Arm A.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
anemia
|
50.0%
2/4 • Number of events 4 • up to 2 years
Adverse events and serious adverse events will be collected for up to 30 days after the last administration of the investigational agent/intervention
|
50.0%
2/4 • Number of events 2 • up to 2 years
Adverse events and serious adverse events will be collected for up to 30 days after the last administration of the investigational agent/intervention
|
50.0%
1/2 • Number of events 2 • up to 2 years
Adverse events and serious adverse events will be collected for up to 30 days after the last administration of the investigational agent/intervention
|
|
Hepatobiliary disorders
AST increased
|
25.0%
1/4 • Number of events 2 • up to 2 years
Adverse events and serious adverse events will be collected for up to 30 days after the last administration of the investigational agent/intervention
|
0.00%
0/4 • up to 2 years
Adverse events and serious adverse events will be collected for up to 30 days after the last administration of the investigational agent/intervention
|
0.00%
0/2 • up to 2 years
Adverse events and serious adverse events will be collected for up to 30 days after the last administration of the investigational agent/intervention
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/4 • up to 2 years
Adverse events and serious adverse events will be collected for up to 30 days after the last administration of the investigational agent/intervention
|
0.00%
0/4 • up to 2 years
Adverse events and serious adverse events will be collected for up to 30 days after the last administration of the investigational agent/intervention
|
50.0%
1/2 • Number of events 1 • up to 2 years
Adverse events and serious adverse events will be collected for up to 30 days after the last administration of the investigational agent/intervention
|
|
General disorders
Chest pain
|
25.0%
1/4 • Number of events 2 • up to 2 years
Adverse events and serious adverse events will be collected for up to 30 days after the last administration of the investigational agent/intervention
|
25.0%
1/4 • Number of events 1 • up to 2 years
Adverse events and serious adverse events will be collected for up to 30 days after the last administration of the investigational agent/intervention
|
50.0%
1/2 • Number of events 1 • up to 2 years
Adverse events and serious adverse events will be collected for up to 30 days after the last administration of the investigational agent/intervention
|
|
General disorders
Dyspnea
|
100.0%
4/4 • Number of events 4 • up to 2 years
Adverse events and serious adverse events will be collected for up to 30 days after the last administration of the investigational agent/intervention
|
25.0%
1/4 • Number of events 1 • up to 2 years
Adverse events and serious adverse events will be collected for up to 30 days after the last administration of the investigational agent/intervention
|
50.0%
1/2 • Number of events 2 • up to 2 years
Adverse events and serious adverse events will be collected for up to 30 days after the last administration of the investigational agent/intervention
|
|
General disorders
Fatigue
|
50.0%
2/4 • Number of events 4 • up to 2 years
Adverse events and serious adverse events will be collected for up to 30 days after the last administration of the investigational agent/intervention
|
75.0%
3/4 • Number of events 8 • up to 2 years
Adverse events and serious adverse events will be collected for up to 30 days after the last administration of the investigational agent/intervention
|
50.0%
1/2 • Number of events 11 • up to 2 years
Adverse events and serious adverse events will be collected for up to 30 days after the last administration of the investigational agent/intervention
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place