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

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00054886
Collaborator
(none)
63
Enrollment
15
Locations
19
Duration (Months)
4.2
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

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
Phase 2

Study Design

Study Type:
Interventional
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 :
Jan 1, 2003
Actual Study Completion Date :
Aug 1, 2004

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

  1. 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

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Pfizer Investigational Site Los Angeles California United States 90095
2 Pfizer Investigational Site Mission Hills California United States 91345
3 Pfizer Investigational Site Monterey Park California United States 91754
4 Pfizer Investigational Site Northridge California United States 91328
5 Pfizer Investigational Site San Francisco California United States 94115
6 Pfizer Investigational Site San Francisco California United States 94121
7 Pfizer Investigational Site Boston Massachusetts United States 02114
8 Pfizer Investigational Site Boston Massachusetts United States 02115
9 Pfizer Investigational Site Ann Arbor Michigan United States 48109
10 Pfizer Investigational Site Henderson Nevada United States 89052
11 Pfizer Investigational Site Las Vegas Nevada United States 89109
12 Pfizer Investigational Site Las Vegas Nevada United States 89128
13 Pfizer Investigational Site New York New York United States 10021
14 Pfizer Investigational Site Philadelphia Pennsylvania United States 19111
15 Pfizer Investigational Site Madison Wisconsin United States 53792

Sponsors and Collaborators

  • Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00054886
Other Study ID Numbers:
  • RTKC-0511-014
First Posted:
Feb 13, 2003
Last Update Posted:
May 7, 2007
Last Verified:
Jul 1, 2006
Additional relevant MeSH terms:
Kidney Neoplasms
Sunitinib

Study Results

No Results Posted as of May 7, 2007