A Pivotal Study Of SU011248 In The Treatment Of Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma. - Full Text View

Purpose

To assess the safety and efficacy of SU011248 in patients with metastatic, refractory renal cell carcinoma

Condition	Intervention	Phase
Carcinoma, Renal Cell	Drug: SU011248	Phase II

Drug Information available for:

Sunitinib Sunitinib malate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Official Title:	A Pivotal Study Of SU011248 In The Treatment Of Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma

Further study details as provided by Pfizer:

Primary Outcome Measures:

Objective response rate according to RECIST [ Time Frame: 4 yrs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Other anti-tumor efficacy including progression-free survival, overall survival, and duration of response and safety [ Time Frame: 4 yrs ] [ Designated as safety issue: No ]

Enrollment:	106
Study Start Date:	February 2004
Estimated Study Completion Date:	October 2008
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: SU011248 50-mg orally taken daily for 4 weeks and off treatment for 2 weeks until progression or unacceptable toxicity

Eligibility

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

Criteria

Inclusion Criteria:

Cytokine refractory metastatic renal cell carcinoma with clear cell component
Radiographic evidence of disease progression during or within 9 months of completion of 1 cytokine therapy
Prior nephrectomy

Exclusion Criteria:

Prior treatment with any systemic therapy other than 1 cytokine therapy
History of or known brain metastases
Uncontrolled hypertension or other significant cardiac events within the 12 months prior to study start

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00077974

Locations


United States, California
	Pfizer Investigational Site
	San Francisco, California, United States, 94115
	Pfizer Investigational Site
	Duarte, California, United States, 91010-3000
	Pfizer Investigational Site
	Pasadena, California, United States, 91105

United States, Massachusetts
	Pfizer Investigational Site
	Boston, Massachusetts, United States, 02114
	Pfizer Investigational Site
	Boston, Massachusetts, United States, 02115
	Pfizer Investigational Site
	Boston, Massachusetts, United States, 02215

United States, Michigan
	Pfizer Investigational Site
	ANN ARBOR, Michigan, United States, 48109

United States, Minnesota
	Pfizer Investigational Site
	Rochester, Minnesota, United States, 55905

United States, New York
	Pfizer Investigational Site
	NEW YORK, New York, United States, 10021
	Pfizer Investigational Site
	New York, New York, United States, 10022

United States, North Carolina
	Pfizer Investigational Site
	Durhan, North Carolina, United States, 27705

United States, Ohio
	Pfizer Investigational Site
	Cleveland, Ohio, United States, 44195

United States, Oregon
	Pfizer Investigational Site
	Portland, Oregon, United States, 97213

United States, Pennsylvania
	Pfizer Investigational Site
	Philadelphia, Pennsylvania, United States, 19111

United States, Wisconsin
	Pfizer Investigational Site
	Madison, Wisconsin, United States, 53792

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:

Motzer RJ, Rini BI, Bukowski RM, Curti BD, George DJ, Hudes GR, Redman BG, Margolin KA, Merchan JR, Wilding G, Ginsberg MS, Bacik J, Kim ST, Baum CM, Michaelson MD. Sunitinib in patients with metastatic renal cell carcinoma. JAMA. 2006 Jun 7;295(21):2516-24.

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A6181006
First Received:	February 13, 2004
Last Updated:	November 21, 2008
ClinicalTrials.gov Identifier:	NCT00077974
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Urogenital Neoplasms

Renal cancer

Urologic Neoplasms

Kidney cancer

Carcinoma

Urologic Diseases

Kidney Neoplasms

Sunitinib

Carcinoma, Renal Cell

Kidney Diseases

Adenocarcinoma

Urinary tract neoplasm

Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

Neoplasms by Histologic Type

Antineoplastic Agents

Growth Substances

Therapeutic Uses

Physiological Effects of Drugs

Growth Inhibitors

Angiogenesis Modulating Agents

Angiogenesis Inhibitors

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2008

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00077974