Retrospective Observational Study To Update 5-Year Survival Of Subjects Who Participated In Axitinib Trial A4061012
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01056263
First received: January 25, 2010
Last updated: April 18, 2012
Last verified: April 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Carcinoma, Renal Cell |
Drug: axitinib: observational study |
| Study Type: | Observational |
| Study Design: | Time Perspective: Retrospective |
| Official Title: | Retrospective Observational Study Of Subjects With Cytokine-Refractory Metastatic Renal Cancer Treated With Axitinib (AG-013736) To Estimate 5-Yr Survival |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Overall Survival (OS) [ Time Frame: Baseline until death or up to Year 5 ] [ Designated as safety issue: No ]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.
| Enrollment: | 52 |
| Study Start Date: | April 2010 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Non-Interventional Study
Subjects participating in this observational study originally participated in study A4061012 [NCT00076011], and may have also have participated in study A4061008 [NCT00828919].
|
Drug: axitinib: observational study
Non-interventional observational study
Other Name: AG-013736
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Subjects participating in this observational study originally participated in study A4061012 [NCT00076011], and may have also have participated in study A4061008 [NCT00828919].
Criteria
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]
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01056263
Locations
| United States, California | |
| Pfizer Investigational Site | |
| San Francisco, California, United States, 94115 | |
| United States, Massachusetts | |
| Pfizer Investigational Site | |
| Boston, Massachusetts, United States, 02215 | |
| Pfizer Investigational Site | |
| Boston, Massachusetts, United States, 02114 | |
| United States, New York | |
| Pfizer Investigational Site | |
| New York, New York, United States, 10065 | |
| United States, Ohio | |
| Pfizer Investigational Site | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Wisconsin | |
| Pfizer Investigational Site | |
| Madison, Wisconsin, United States, 53792 | |
| France | |
| Pfizer Investigational Site | |
| Paris Cedex 13, France, 75651 | |
| Germany | |
| Pfizer Investigational Site | |
| Hannover, Germany, 30625 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01056263 History of Changes |
| Other Study ID Numbers: | A4061065 |
| Study First Received: | January 25, 2010 |
| Results First Received: | February 25, 2012 |
| Last Updated: | April 18, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
retrospective trial 5-year survival metastatic renal cancer cell |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Renal Cell Kidney Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Adenocarcinoma Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on June 17, 2013