Anti-Angiogenesis Agent AG-013736 in Patients With Metastatic Renal Cell Carcinoma - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00076011

Purpose

The primary purpose of this protocol is to determine the activity of AG 013736 in patients with metastatic renal cell cancer who have received 1 prior cytokine-based therapy.

Condition	Intervention	Phase
Kidney Neoplasms	Drug: VEGFR and PDGFR inhibitor	Phase II

MedlinePlus related topics: Cancer Kidney Cancer

Drug Information available for: Axitinib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase 2 Study of AG 013736 as Second-Line Treatment in Patients With Metastatic Renal Cell Cancer

Further study details as provided by Pfizer:

Primary Outcome Measures:

response rate

Secondary Outcome Measures:

safety profile of AG 013736
time to progression
duration of response
overall survival
explore the effects of treatment on health-related quality of life (HQoL) and the responsiveness and sensitivity of the HQoL instrument in this study population
explore pharmacokinetic correlates with response or adverse events

Estimated Enrollment:	52
Study Start Date:	October 2003

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically documented RCC with metastases.
Failure of 1 prior cytokine-based therapy (interleukin-2 and/or interferon) due to disease progression or unacceptable treatment-related toxicity

Exclusion Criteria:

Any prior systemic treatment for RCC other than 1 prior cytokine-based treatment regimen. Cytokine-based regimens containing thalidomide or an anti-angiogenesis agent are not allowed.
Inability to take oral medication

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00076011

Locations

United States, California
Pfizer Investigational Site
San Francisco, California, United States, 94115
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02114
Pfizer Investigational Site
Boston, Massachusetts, United States, 02115
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10021
United States, Ohio
Pfizer Investigational Site
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19111-2497
United States, Wisconsin
Pfizer Investigational Site
Madison, Wisconsin, United States, 53792
France, Paris
Pfizer Investigational Site
Paris Cedex 13, Paris, France, 75651
Germany
Pfizer Investigational Site
30625 Hannover, Germany

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Publications indexed to this study:

Rixe O, Bukowski RM, Michaelson MD, Wilding G, Hudes GR, Bolte O, Motzer RJ, Bycott P, Liau KF, Freddo J, Trask PC, Kim S, Rini BI. Axitinib treatment in patients with cytokine-refractory metastatic renal-cell cancer: a phase II study. Lancet Oncol. 2007 Nov;8(11):975-84. Epub 2007 Oct 23.

Study ID Numbers:	A4061012
Study First Received:	January 12, 2004
Last Updated:	August 14, 2007
ClinicalTrials.gov Identifier:	NCT00076011
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell
Urogenital Neoplasms
Renal cancer

Kidney Diseases
Kidney cancer
Urologic Neoplasms
Urinary tract neoplasm
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 15, 2009