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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.
Information provided by:
Pfizer Identifier:
First received: February 12, 2003
Last updated: May 4, 2007
Last verified: July 2006

February 12, 2003
May 4, 2007
January 2003
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The primary endpoint was overall response rate (ORR) and the ORR achieved for the study was 40%.
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Complete list of historical versions of study NCT00054886 on Archive Site
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.
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Study of the Safety and Efficacy of SU-011,248 in Adult Patients With Advanced Kidney Cancer
Phase II Study Of Single-Agent SU011248 In The Second-Line Treatment Of Patients With Metastatic Renal Cell Carcinoma
The primary goal of the study is to evaluate the effectiveness and safety of SU-011,248 as a treatment for metastatic kidney cancer.
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Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Kidney Neoplasms
Drug: SU-011,248
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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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
August 2004
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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.
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Study Director: Pfizer Call Center Pfizer
July 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP