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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

Tracking Information
First Submitted Date  ICMJE February 12, 2003
First Posted Date  ICMJE February 13, 2003
Last Update Posted Date May 7, 2007
Study Start Date  ICMJE January 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: July 5, 2006)
The primary endpoint was overall response rate (ORR) and the ORR achieved for the study was 40%.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00054886 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 5, 2006)
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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of the Safety and Efficacy of SU-011,248 in Adult Patients With Advanced Kidney Cancer
Official Title  ICMJE Phase II Study Of Single-Agent SU011248 In The Second-Line Treatment Of Patients With Metastatic Renal Cell Carcinoma
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Kidney Neoplasms
Intervention  ICMJE Drug: SU-011,248
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: July 5, 2006)
63
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE August 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00054886
Other Study ID Numbers  ICMJE RTKC-0511-014
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date July 2006

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