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SU011248 In The Treatment Of Patients With Bevacizumab (Avastin)-Refractory Metastatic Renal Cell Carcinoma

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NCT00089648

Last updated on May 12, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Duarte, California, 91010 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Renal Cell Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Histologically proven renal cell carcinoma of clear cell histology with metastases

- Evidence of measurable disease

- Radiographic evidence of disease progression during or within 3 months of completion
of bevacizumab-based treatment

- Prior radical or partial nephrectomy

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Prior treatment with any other anti-angiogenic therapy other than bevacizumab

- Prior systemic treatment for RCC > 2 regimens

- History of or known brain metastases

- Serious acute or chronic illness or recent history of significant cardiac abnormality

NCT00089648
Pfizer
Completed
SU011248 In The Treatment Of Patients With Bevacizumab (Avastin)-Refractory Metastatic Renal Cell Carcinoma

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SU011248 In The Treatment Of Patients With Bevacizumab (Avastin)-Refractory Metastatic Renal Cell Carcinoma
A Phase 2 Study Of SU011248 In The Treatment Of Patients With Bevacizumab-Refractory Metastatic Renal Cell Carcinoma
The purpose of this study is to test whether sunitinib (SU011248) has activity and is safe in patients with renal cell carcinoma (RCC) who have failed prior therapy with bevacizumab (Avastin) -based treatment.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Carcinoma, Renal Cell
Drug: Sunitinib
50 mg orally daily for 4 weeks followed by 2 weeks off treatment for approximately 1 year or until disease progression/unacceptable toxicity; after completion of 1 year, pts with clinical benefit can continue the study treatment in a separate continuation protocol
Other Name: SUTENT, SU011248,
Experimental: 1
Intervention: Drug: Sunitinib
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
61
March 2008
January 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically proven renal cell carcinoma of clear cell histology with metastases
  • Evidence of measurable disease
  • Radiographic evidence of disease progression during or within 3 months of completion of bevacizumab-based treatment
  • Prior radical or partial nephrectomy

Exclusion Criteria:

  • Prior treatment with any other anti-angiogenic therapy other than bevacizumab
  • Prior systemic treatment for RCC > 2 regimens
  • History of or known brain metastases
  • Serious acute or chronic illness or recent history of significant cardiac abnormality
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00089648
A6181039
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2010

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

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