Trial Outcomes & Findings for Azacitidine in Treating Patients With Previously Treated Advanced Non-Small Cell Lung Cancer (NCT NCT01281124)

Last Updated: 2019-09-24

Results Overview

The change in mean methylation of the genes between the patients with a low mir29 and a high mir29 expression will be evaluated by a two-sample t-test. Secondary analyses include a multivariate regression where all 5 changes in methylation will be regressed on mir29 expression (low vs. high) and adjusted for patient demographic and clinical attributes at baseline.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

Up to 12 weeks after completion of study treatment

Results posted on

2019-09-24

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (5-Azacytidine) Patients receive 5-azacitidine subcutaneously at the starting dose level of 75 mg/m2 on an outpatient basis daily for 7 days on a 28 day cycle.
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (5-Azacytidine) Patients receive 5-azacitidine subcutaneously at the starting dose level of 75 mg/m2 on an outpatient basis daily for 7 days on a 28 day cycle.
Overall Study Death	1

Baseline Characteristics

Azacitidine in Treating Patients With Previously Treated Advanced Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Azacitidine) n=1 Participants Patients receive azacitidine subcutaneously on days 1-7. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Sex: Female, Male Female	0 Participants n=99 Participants
Sex: Female, Male Male	1 Participants n=99 Participants
Region of Enrollment United States	1 participants n=99 Participants

PRIMARY outcome

Timeframe: Up to 12 weeks after completion of study treatment

Population: Data analysis was not done due to low accrual for this trial.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the day of initial treatment until death (from any cause), assessed up to 12 weeks after completion of study treatment

Population: Data analysis was not done due to low accrual for this trial.

Analyzed using a Kaplan-Meier methods.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the day of initial treatment until documented disease progression (per PET) or death, assessed up to 12 weeks after completion of study treatment

Population: Data analysis was not done due to low accrual for this trial.

Analyzed using a Kaplan-Meier methods.

Outcome measures

Outcome data not reported

Adverse Events

Treatment (Azacitidine)

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Azacitidine) n=1 participants at risk Patients receive azacitidine subcutaneously on days 1-7. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cardiac disorders Cardiac Arrest	100.0% 1/1 • Number of events 1 • Baseline through end of follow up period (12 weeks after removal from study or until death, whichever occurs first). Patients removed from study for unacceptable adverse events will be followed until resolution or stabilization of the adverse event.
Cardiac disorders Pericardial effusion	100.0% 1/1 • Number of events 1 • Baseline through end of follow up period (12 weeks after removal from study or until death, whichever occurs first). Patients removed from study for unacceptable adverse events will be followed until resolution or stabilization of the adverse event.
Cardiac disorders Pericardial tamponade	100.0% 1/1 • Number of events 1 • Baseline through end of follow up period (12 weeks after removal from study or until death, whichever occurs first). Patients removed from study for unacceptable adverse events will be followed until resolution or stabilization of the adverse event.
Investigations Lymphocyte count decreased	100.0% 1/1 • Number of events 1 • Baseline through end of follow up period (12 weeks after removal from study or until death, whichever occurs first). Patients removed from study for unacceptable adverse events will be followed until resolution or stabilization of the adverse event.
Metabolism and nutrition disorders Anorexia	100.0% 1/1 • Number of events 1 • Baseline through end of follow up period (12 weeks after removal from study or until death, whichever occurs first). Patients removed from study for unacceptable adverse events will be followed until resolution or stabilization of the adverse event.
Metabolism and nutrition disorders Hypoalbuminemia	100.0% 1/1 • Number of events 1 • Baseline through end of follow up period (12 weeks after removal from study or until death, whichever occurs first). Patients removed from study for unacceptable adverse events will be followed until resolution or stabilization of the adverse event.
Metabolism and nutrition disorders Hypocalcemia	100.0% 1/1 • Number of events 1 • Baseline through end of follow up period (12 weeks after removal from study or until death, whichever occurs first). Patients removed from study for unacceptable adverse events will be followed until resolution or stabilization of the adverse event.
Metabolism and nutrition disorders Hyponatremia	100.0% 1/1 • Number of events 1 • Baseline through end of follow up period (12 weeks after removal from study or until death, whichever occurs first). Patients removed from study for unacceptable adverse events will be followed until resolution or stabilization of the adverse event.
Psychiatric disorders Insomnia	100.0% 1/1 • Number of events 1 • Baseline through end of follow up period (12 weeks after removal from study or until death, whichever occurs first). Patients removed from study for unacceptable adverse events will be followed until resolution or stabilization of the adverse event.
Respiratory, thoracic and mediastinal disorders Dyspnea	100.0% 1/1 • Number of events 1 • Baseline through end of follow up period (12 weeks after removal from study or until death, whichever occurs first). Patients removed from study for unacceptable adverse events will be followed until resolution or stabilization of the adverse event.
Respiratory, thoracic and mediastinal disorders Pleural effusion	100.0% 1/1 • Number of events 1 • Baseline through end of follow up period (12 weeks after removal from study or until death, whichever occurs first). Patients removed from study for unacceptable adverse events will be followed until resolution or stabilization of the adverse event.

Other adverse events

Other adverse events
Measure	Treatment (Azacitidine) n=1 participants at risk Patients receive azacitidine subcutaneously on days 1-7. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Skin and subcutaneous tissue disorders Urticaria (Welts)	100.0% 1/1 • Number of events 2 • Baseline through end of follow up period (12 weeks after removal from study or until death, whichever occurs first). Patients removed from study for unacceptable adverse events will be followed until resolution or stabilization of the adverse event.
Respiratory, thoracic and mediastinal disorders Dyspnea	100.0% 1/1 • Number of events 1 • Baseline through end of follow up period (12 weeks after removal from study or until death, whichever occurs first). Patients removed from study for unacceptable adverse events will be followed until resolution or stabilization of the adverse event.
Metabolism and nutrition disorders Anorexia	100.0% 1/1 • Number of events 1 • Baseline through end of follow up period (12 weeks after removal from study or until death, whichever occurs first). Patients removed from study for unacceptable adverse events will be followed until resolution or stabilization of the adverse event.
Infections and infestations Pneumonia-Viral	100.0% 1/1 • Number of events 1 • Baseline through end of follow up period (12 weeks after removal from study or until death, whichever occurs first). Patients removed from study for unacceptable adverse events will be followed until resolution or stabilization of the adverse event.
Investigations Lymphopenia	100.0% 1/1 • Number of events 2 • Baseline through end of follow up period (12 weeks after removal from study or until death, whichever occurs first). Patients removed from study for unacceptable adverse events will be followed until resolution or stabilization of the adverse event.
Psychiatric disorders Depression	100.0% 1/1 • Number of events 1 • Baseline through end of follow up period (12 weeks after removal from study or until death, whichever occurs first). Patients removed from study for unacceptable adverse events will be followed until resolution or stabilization of the adverse event.
Metabolism and nutrition disorders Hyponatremia	100.0% 1/1 • Number of events 1 • Baseline through end of follow up period (12 weeks after removal from study or until death, whichever occurs first). Patients removed from study for unacceptable adverse events will be followed until resolution or stabilization of the adverse event.
General disorders Fatigue	100.0% 1/1 • Number of events 1 • Baseline through end of follow up period (12 weeks after removal from study or until death, whichever occurs first). Patients removed from study for unacceptable adverse events will be followed until resolution or stabilization of the adverse event.

Additional Information

Greg Otterson

The Ohio State University Comprehensive Cancer Center

Phone: 614-293-2887

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60