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NCT01056263 Clinical Trial

Retrospective Observational Study To Update 5-Year Survival Of Subjects Who Participated In Axitinib Trial A4061012

Carcinoma, Renal Cell Clinical Trial

Official title:
Retrospective Observational Study Of Subjects With Cytokine-Refractory Metastatic Renal Cancer Treated With Axitinib (AG-013736) To Estimate 5-Yr Survival

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01056263
Other study ID # A4061065
Secondary ID
Status Completed
Phase N/A
First received January 25, 2010
Last updated April 18, 2012
Start date April 2010
Est. completion date December 2010

Study information
Verified date April 2012
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 52
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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]

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Drug:
• axitinib: observational study
Non-interventional observational study

Locations
Country Name City State
France Pfizer Investigational Site Paris Cedex 13
Germany Pfizer Investigational Site Hannover
United States Pfizer Investigational Site Boston Massachusetts
United States Pfizer Investigational Site Boston Massachusetts
United States Pfizer Investigational Site Cleveland Ohio
United States Pfizer Investigational Site Madison Wisconsin
United States Pfizer Investigational Site New York New York
United States Pfizer Investigational Site San Francisco California

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  France,  Germany, 

Outcome
Type Measure Description Time frame Safety issue
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. Baseline until death or up to Year 5 No
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