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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01056263
First received: January 25, 2010
Last updated: April 18, 2012
Last verified: April 2012
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014