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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00054886
First received: February 12, 2003
Last updated: May 4, 2007
Last verified: July 2006
History of Changes
  Purpose

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 Intervention Phase
Kidney Neoplasms
 Drug: SU-011,248
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

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.

Estimated Enrollment: 63
Study Start Date: January 2003
Study Completion Date: August 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00054886

Locations
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
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

No publications provided

ClinicalTrials.gov Identifier: NCT00054886     History of Changes
Other Study ID Numbers: RTKC-0511-014
Study First Received: February 12, 2003
Last Updated: May 4, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
 Neoplasms by Site
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 23, 2013