Study of the Safety and Efficacy of SU-011,248 in Adult Patients With Advanced Kidney Cancer

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ClinicalTrials.gov Identifier: NCT00054886

Recruitment Status : Completed

First Posted : February 13, 2003

Last Update Posted : May 7, 2007

Sponsor:

Information provided by:

Pfizer

Study Description

Brief Summary:

The primary goal of the study is to evaluate the effectiveness and safety of SU-011,248 as a treatment for metastatic kidney cancer.

Condition or disease	Intervention/treatment	Phase
Kidney Neoplasms	Drug: SU-011,248	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	63 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Phase II Study Of Single-Agent SU011248 In The Second-Line Treatment Of Patients With Metastatic Renal Cell Carcinoma
Study Start Date :	January 2003
Actual Study Completion Date :	August 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Cancer

Drug Information available for: Sunitinib malate Sunitinib

Genetic and Rare Diseases Information Center resources: Renal Cell Carcinoma Clear Cell Renal Cell Carcinoma

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

The primary endpoint was overall response rate (ORR) and the ORR achieved for the study was 40%.

Secondary Outcome Measures :

The secondary endpoints included time to progression (TTP) and overall survival (OS). The median TTP for the study was 8.7 months and the median OS was 16.4 months. SU011248 was generally well tolerated.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Eligible patients must be at least 18 years of age with a diagnosis of metastatic kidney cancer.
The patient's kidney cancer must have gotten worse during/after previous cytokine-based therapy was given.
Any side effects from prior therapy must have subsided, and blood and urine tests must show adequate bone marrow, liver, and kidney function

Exclusion Criteria:

Prior treatment with any systemic therapy other than 1 prior cytokine-based treatment regimen;
Prior surgical resection of or irradiation to the only site of measurable disease;
Ongoing severe hematuria;
Other active second malignancy;
Cardiovascular diseases or conditions within the last 12 months;
Known brain metastases;
Known HIV-positive or AIDS-related illness;
Pregnant or breast-feeding women;
Current participation in other clinical trials;
Other severe acute or chronic medical conditions.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00054886

Locations

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United States, California
Pfizer Investigational Site
Los Angeles, California, United States, 90095
Pfizer Investigational Site
Mission Hills, California, United States, 91345
Pfizer Investigational Site
Monterey Park, California, United States, 91754
Pfizer Investigational Site
Northridge, California, United States, 91328
Pfizer Investigational Site
San Francisco, California, United States, 94115
Pfizer Investigational Site
San Francisco, California, United States, 94121
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02114
Pfizer Investigational Site
Boston, Massachusetts, United States, 02115
United States, Michigan
Pfizer Investigational Site
Ann Arbor, Michigan, United States, 48109
United States, Nevada
Pfizer Investigational Site
Henderson, Nevada, United States, 89052
Pfizer Investigational Site
Las Vegas, Nevada, United States, 89109
Pfizer Investigational Site
Las Vegas, Nevada, United States, 89128
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10021
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

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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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

de Velasco G, McKay RR, Lin X, Moreira RB, Simantov R, Choueiri TK. Comprehensive Analysis of Survival Outcomes in Non-Clear Cell Renal Cell Carcinoma Patients Treated in Clinical Trials. Clin Genitourin Cancer. 2017 Dec;15(6):652-660.e1. doi: 10.1016/j.clgc.2017.03.004. Epub 2017 Mar 21.

Grünwald V, Lin X, Kalanovic D, Simantov R. Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma. Eur Urol. 2016 Dec;70(6):1006-1015. doi: 10.1016/j.eururo.2016.05.010. Epub 2016 May 26.

Grünwald V, McKay RR, Krajewski KM, Kalanovic D, Lin X, Perkins JJ, Simantov R, Choueiri TK. Depth of remission is a prognostic factor for survival in patients with metastatic renal cell carcinoma. Eur Urol. 2015 May;67(5):952-8. doi: 10.1016/j.eururo.2014.12.036. Epub 2015 Jan 7.

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ClinicalTrials.gov Identifier:	NCT00054886
Other Study ID Numbers:	RTKC-0511-014
First Posted:	February 13, 2003 Key Record Dates
Last Update Posted:	May 7, 2007
Last Verified:	July 2006

Additional relevant MeSH terms:

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Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Kidney Diseases Urologic Diseases Sunitinib Antineoplastic Agents	Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

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