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

Completed

• Conditions: Carcinoma, Renal Cell

• Registration Number: NCT01056263
• Lead Sponsor: Pfizer

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.

Study Timeline

• Study First Submitted: 2010-01-25
• Study First Submitted QC: 2010-01-25
• Study First Posted: 2010-01-26
• Study Start: 2010-04
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Results First Submitted: 2012-02-25
• Results First Submitted QC: 2012-02-25
• Results First Posted: 2012-03-28
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-18
• Last Update Posted: 2012-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇩🇪 Hannover, Germany