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Phase II Study Of Single-Agent SU011248 In The Second-Line Treatment Of Patients With Metastatic Renal Cell Carcinoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Kidney Neoplasms

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Trial Information

Phase II Study Of Single-Agent SU011248 In The Second-Line Treatment Of Patients With Metastatic Renal Cell Carcinoma


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.

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:

The primary endpoint was overall response rate (ORR) and the ORR achieved for the study was 40%.

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

RTKC-0511-014

NCT ID:

NCT00054886

Start Date:

January 2003

Completion Date:

August 2004

Related Keywords:

  • Kidney Neoplasms
  • Neoplasms
  • Kidney Neoplasms

Name

Location

Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteDetroit, Michigan  48201
Pfizer Investigational SiteBronx, New York  10461
Pfizer Investigational SiteNorth Adams, Massachusetts  01247
Pfizer Investigational SiteLas Vegas, Nevada  89128
Pfizer Investigational SiteKingston, Pennsylvania  18704-5535
Pfizer Investigational SiteMilwaukee, Wisconsin  53215