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SU011248 in the Treatment of Patients with Bevacizumab (Avastin)-Refractory Metastatic Renal Cell Carcinoma - Article


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Skin Carcinoma, Merkel Cell

 




Clinical Trial: SU011248 in the Treatment of Patients with Bevacizumab (Avastin)-Refractory Metastatic Renal Cell Carcinoma

This study is currently recruiting patients.

Sponsored by: Pfizer
Information provided by: Pfizer

Purpose

The purpose of this study is to test whether SU011248 has activity and is safe in patients with Renal Cell Carcinoma (RCC) and who have failed prior therapy with bevacizumab (Avastin).

Condition Treatment or Intervention Phase
Renal Cell Carcinoma
 Drug: SU011248
Phase II

MedlinePlus related topics:  Cancer;   Kidney Cancer

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title: A Phase 2 Study of SU011248 in the Treatment of Patients with Bevacizumab (Avastin)-Refractory Metastatic Renal Cell Carcinoma

Further Study Details: 

Expected Total Enrollment:  60

Study start: September 2004

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

  • Histologically proven renal cell carcinoma of clear cell histology with metastases. RCC of papillary, collecting duct or chromophobe type without clear cell component is not permitted. In addition, transitional cell carcinoma of the renal pelvis is not allowed.
  • Evidence of measurable disease by radiographic technique
  • Radiographic evidence of disease progression during or within 3 months of completion of bevacizumab-based treatment
  • Prior radical or partial nephrectomy
  • Male or female, 18 years or older
  • ECOG performace status of 0 or 1
  • Resolution of all acute toxicitites of prior therapies
  • Adequate organ function
  • No prior treatment with any other anti-angiogenic therapy other than bevacizumab
  • No prior systemic treatment for RCC > 2 regimens
  • No prior surgery, radiation, or systemic therapy within 4 weeks
  • No diagnosis of a second malignancy within the last 3 years
  • No known brain metastases, spinal cord compression or carcinomatous meningitis
  • No known HIV or AIDS-related illness
  • No serious acute or chronic illness or recent history of significant cardiac abnormality
  • No uncontrolled hypertension

Location and Contact Information

SU011248 Clinical Trial Information Service:      1-877-416-6248 
[NEW LOCATIONS ARE UPDATED TO THIS WEBSITE MONTHLY...... FOR MORE CURRENT INFORMATION, PLEASE CALL THE NUMBER LISTED.]    

California
      Pfizer Investigational Site, San Francisco,  California,  94115,  United States; Recruiting

Illinois
      Pfizer Investigational Site, Chicago,  Illinois,  60637,  United States; Recruiting

North Carolina
      Pfizer Investigational Site, Durham,  North Carolina,  27710,  United States; Recruiting

More Information

Study ID Numbers:  A6181039
Record last reviewed:  March 2005
Last Updated:  March 15, 2005
Record first received:  August 9, 2004
ClinicalTrials.gov Identifier:  NCT00089648
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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Page Updated: September 23, 2004
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