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

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

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

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Sunitinib malate Sunitinib

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Number of Subjects With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors(RECIST) [ Time Frame: From start of study treatment until confirmed objective response ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to Tumor Progression (TTP) [ Time Frame: From start of study treatment until disease progression or discontinuation from study ] [ Designated as safety issue: No ]
Duration of Response (DR) [ Time Frame: From the first documentation of objective tumor response to the first documentation of objective tumor progression or death due to cancer ] [ Designated as safety issue: No ]
Overall Survival (OS) [ Time Frame: From start of study treatment until death ] [ Designated as safety issue: No ]
Progression-free Survival (PFS) [ Time Frame: From start of study treatment until disease progression or death ] [ Designated as safety issue: No ]
Probability of Patient Survival [ Time Frame: From start of study treatment until death ] [ Designated as safety issue: No ]
Plasma Trough Concentrations of Sunitinib [ Time Frame: Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater ] [ Designated as safety issue: No ]
Plasma Trough Concentrations of Sunitinib Metabolite [ Time Frame: Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater ] [ Designated as safety issue: No ]
Plasma Trough Concentrations of Sunitinib Plus Metabolite [ Time Frame: Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater ] [ Designated as safety issue: No ]

Enrollment:	106
Study Start Date:	February 2004
Study Completion Date:	September 2008
Primary Completion Date:	September 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
Durham, 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

Additional Information:

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

Link to ClinicalStudyResults.org posting This link exits the ClinicalTrials.gov site

No publications provided by Pfizer

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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
Study First Received:	February 13, 2004
Results First Received:	September 25, 2009
Last Updated:	September 25, 2009
ClinicalTrials.gov Identifier:	NCT00077974 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Urogenital Neoplasms
Urologic Neoplasms
Angiogenesis Inhibitors
Pharmacologic Actions
Carcinoma
Neoplasms
Neoplasms by Site

Urologic Diseases
Kidney Neoplasms
Sunitinib
Therapeutic Uses
Carcinoma, Renal Cell
Growth Inhibitors
Angiogenesis Modulating Agents
Kidney Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 09, 2009