Treatment Use Study With Sunitinib (SU011248) For Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma - Full Text View

Purpose

To provide access to sunitinib to patients with metastatic renal cell carcinoma. People in this study will have been previously treated with cytokine therapy, e.g. interferon-alpha, but this is no longer effective.

Condition	Intervention	Phase
Carcinoma, Renal Cell	Drug: sunitinib malate	Phase III

ChemIDplus related topics:

Sunitinib Sunitinib malate Malic acid

U.S. FDA Resources

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

Official Title:	A SU011248 Treatment Protocol For Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma Who Are Ineligible For Participation In Other SU011248 Protocols And May Derive Benefit From Treatment With SU011248

Further study details as provided by Pfizer:

Primary Outcome Measures:

Evaluation of overall response rate will be conducted according to RECIST criteria. [ Time Frame: end of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to Tumor Progression [ Time Frame: end of study ] [ Designated as safety issue: No ]
Overall Survival [ Time Frame: end of study ] [ Designated as safety issue: No ]
Overall Response Rate [ Time Frame: end of study ] [ Designated as safety issue: No ]

Estimated Enrollment:	5000
Study Start Date:	June 2005
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A Sutent 25, 37.5, or 50 mg daily	Drug: sunitinib malate sutent, 25, 37.5, or 50 mg daily

Eligibility

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

Criteria

Inclusion Criteria:

renal cell carcinoma that is not amendable to standard therapy with curative intent

Exclusion Criteria:

current treatment in another therapeutic clinical trial

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00130897

Show 277 Study Locations

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

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A6181037
First Received:	August 14, 2005
Last Updated:	September 23, 2008
ClinicalTrials.gov Identifier:	NCT00130897
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 October 03, 2008

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00130897