Carcinoma, Renal Cell
Conditions
Keywords
retrospective trial, 5-year survival, metastatic renal cancer cell
Brief summary
The primary objective of this observational study is to retrospectively collect current survival data for patients originally included in axitinib A4061012 \[NCT00076011\] study to estimate the 5-year survival rate in subjects with metastatic renal cancer cell treated with axitinib.
Detailed description
Subjects participating in this observational study originally participated in study A4061012 \[NCT00076011\], and may have also have participated in study A4061008 \[NCT00828919\]. Subjects participating in this observational study originally participated in study A4061012 \[NCT00076011\], and may have also have participated in study A4061008 \[NCT00828919\]. 5-year survival information to be updated.
Interventions
DRUGaxitinib: observational study
Non-interventional observational study
Sponsors
Pfizer
Study design
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects participating in this observational study originally participated in study A4061012 \[NCT00076011\] and may have also participated in study A4061008 \[NCT00828919\]
Exclusion criteria
* Subjects who withdrew from the original study A4061012 \[NCT00076011\] or the continuing access study A4061008 \[NCT00828919\]
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Baseline until death or up to Year 5 | 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. |
Countries
France, Germany, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 52 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 12 |
| Overall Study | Death | 1 |
| Overall Study | Lack of Efficacy | 29 |
| Overall Study | Neoplasm progression | 1 |
| Overall Study | Objective progression or relapse | 1 |
| Overall Study | Ongoing in study A4061008 (NCT00828919) | 5 |
| Overall Study | Progressive disease | 2 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Axitinib |
|---|---|
| Age Continuous | 58.8 years STANDARD_DEVIATION 11.3 |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Overall Survival (OS)
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.
Time frame: Baseline until death or up to Year 5
Population: Full analysis set included all participants who received at least 1 dose of axitinib (AG-013736).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Axitinib | Overall Survival (OS) | 911.0 Days |
Comparison: Five year survival probability was the probability of survival at 5 year after the date of the start of the study treatment based on the Kaplan-Meier estimate.95% CI: [10.94, 32.38]