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

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NCT01056263

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Study Location
Pfizer Investigational Site
San Francisco, California, 94115, United States
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Renal Cell Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subjects participating in this observational study originally participated in study A4061012 [NCT00076011] and may have also participated in study A4061008 [NCT00828919]

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Subjects who withdrew from the original study A4061012 [NCT00076011] or the continuing
access study A4061008 [NCT00828919]

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Advanced Information
Descriptive Information
Brief Title Retrospective Observational Study To Update 5-Year Survival Of Subjects Who Participated In Axitinib Trial A4061012
Official Title Retrospective Observational Study Of Subjects With Cytokine-Refractory Metastatic Renal Cancer Treated With Axitinib (AG-013736) To Estimate 5-Yr Survival
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 Type Observational
Study Design Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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].
Condition Carcinoma, Renal Cell
Intervention Drug: axitinib: observational study
Non-interventional observational study
Other Name: AG-013736
Study Groups/Cohorts 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].
Intervention: Drug: axitinib: observational study
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 18, 2012)		52
Original Estimated Enrollment
 (submitted: January 25, 2010)		24
Actual Study Completion Date December 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility 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]
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France,   Germany,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01056263
Other Study ID Numbers A4061065
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2012