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

Kidney Neoplasms Clinical Trial

Official title:

Phase II Study Of Single-Agent SU011248 In The Second-Line Treatment Of Patients With Metastatic Renal Cell Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00054886
• Other study ID #: RTKC-0511-014
• Status: Completed
• Phase: Phase 2
• First received: February 12, 2003
• Last updated: May 4, 2007
• Start date: January 2003
• Est. completion date: August 2004

Study information

• Verified date: July 2006
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: August 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Neoplasms

Intervention

Drug:
• SU-011,248

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Ann Arbor	Michigan
United States	Pfizer Investigational Site	Boston	Massachusetts
United States	Pfizer Investigational Site	Boston	Massachusetts
United States	Pfizer Investigational Site	Henderson	Nevada
United States	Pfizer Investigational Site	Las Vegas	Nevada
United States	Pfizer Investigational Site	Las Vegas	Nevada
United States	Pfizer Investigational Site	Los Angeles	California
United States	Pfizer Investigational Site	Madison	Wisconsin
United States	Pfizer Investigational Site	Mission Hills	California
United States	Pfizer Investigational Site	Monterey Park	California
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	Northridge	California
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania
United States	Pfizer Investigational Site	San Francisco	California
United States	Pfizer Investigational Site	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint was overall response rate (ORR) and the ORR achieved for the study was 40%.
Secondary	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.

External Links

•   To obtain contact information for a study center near you, click here.