Trial Outcomes & Findings for Retrospective Observational Study To Update 5-Year Survival Of Subjects Who Participated In Axitinib Trial A4061012 (NCT NCT01056263)
NCT ID: NCT01056263
Last Updated: 2012-04-20
Results Overview
Overall survival is the duration from first dose of study medication to death. For participants who are alive, overall survival is censored at the last contact.
COMPLETED
52 participants
Baseline until death or up to Year 5
2012-04-20
Participant Flow
Participant milestones
| Measure |
Axitinib
The study is aimed to retrospectively update the overall survival data (5-year) collected from participants who participated to a previous completed axitinib (AG-013736) study (A4061012; NCT00076011). Part of these participants continued axitinib (AG-013736) treatment after study A4061012 closure, under the roll over study (A4061008; NCT00828919).
|
|---|---|
|
Overall Study
STARTED
|
52
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
52
|
Reasons for withdrawal
| Measure |
Axitinib
The study is aimed to retrospectively update the overall survival data (5-year) collected from participants who participated to a previous completed axitinib (AG-013736) study (A4061012; NCT00076011). Part of these participants continued axitinib (AG-013736) treatment after study A4061012 closure, under the roll over study (A4061008; NCT00828919).
|
|---|---|
|
Overall Study
Adverse Event
|
12
|
|
Overall Study
Death
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Lack of Efficacy
|
29
|
|
Overall Study
Progressive disease
|
2
|
|
Overall Study
Neoplasm progression
|
1
|
|
Overall Study
Objective progression or relapse
|
1
|
|
Overall Study
Ongoing in study A4061008 (NCT00828919)
|
5
|
Baseline Characteristics
Retrospective Observational Study To Update 5-Year Survival Of Subjects Who Participated In Axitinib Trial A4061012
Baseline characteristics by cohort
| Measure |
Axitinib
n=52 Participants
The study is aimed to retrospectively update the overall survival data (5-year) collected from participants who participated to a previous completed axitinib (AG-013736) study (A4061012; NCT00076011). Part of these participants continued axitinib (AG-013736) treatment after study A4061012 closure, under the roll over study (A4061008; NCT00828919).
|
|---|---|
|
Age Continuous
|
58.8 years
STANDARD_DEVIATION 11.3 • n=99 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline until death or up to Year 5Population: Full analysis set included all participants who received at least 1 dose of axitinib (AG-013736).
Overall survival is the duration from first dose of study medication to death. For participants who are alive, overall survival is censored at the last contact.
Outcome measures
| Measure |
Axitinib
n=52 Participants
The study is aimed to retrospectively update the overall survival data (5-year) collected from participants who participated to a previous completed axitinib (AG-013736) study (A4061012; NCT00076011). Part of these participants continued axitinib (AG-013736) treatment after study A4061012 closure, under the roll over study (A4061008; NCT00828919).
|
|---|---|
|
Overall Survival (OS)
|
911.0 Days
Interval 670.0 to 1283.0
|
Adverse Events
Axitinib
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 Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER