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A Phase 2 Study Of SU011248 In The Treatment Of Patients With Bevacizumab-Refractory Metastatic Renal Cell Carcinoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Carcinoma, Renal Cell

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Trial Information

A Phase 2 Study Of SU011248 In The Treatment Of Patients With Bevacizumab-Refractory Metastatic Renal Cell Carcinoma


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Subjects With Overall Confirmed Objective Disease Response According to the Response Evaluation Criteria in Solid Tumors (RECIST)

Outcome Time Frame:

4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation including 28 day post study follow up

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A6181039

NCT ID:

NCT00089648

Start Date:

December 2004

Completion Date:

March 2008

Related Keywords:

  • Carcinoma, Renal Cell
  • Carcinoma
  • Carcinoma, Renal Cell

Name

Location

Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteCincinnait, Ohio  45236
Pfizer Investigational SiteSpringfield, Illinois  62701-1014
Pfizer Investigational SiteHouston, Texas  77030
Pfizer Investigational SiteNorth Adams, Massachusetts  01247
Pfizer Investigational SiteAsheville, North Carolina  28801
Pfizer Investigational SiteBristol, Tennessee  37620