Study of the Safety and Efficacy of SU-011,248 in Adult Patients With Advanced Kidney Cancer

May 4, 2007 updated by: Pfizer

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

The primary goal of the study is to evaluate the effectiveness and safety of SU-011,248 as a treatment for metastatic kidney cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

63

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Pfizer Investigational Site
      • Mission Hills, California, United States, 91345
        • Pfizer Investigational Site
      • Monterey Park, California, United States, 91754
        • Pfizer Investigational Site
      • Northridge, California, United States, 91328
        • Pfizer Investigational Site
      • San Francisco, California, United States, 94115
        • Pfizer Investigational Site
      • San Francisco, California, United States, 94121
        • Pfizer Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Pfizer Investigational Site
      • Boston, Massachusetts, United States, 02115
        • Pfizer Investigational Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Pfizer Investigational Site
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Pfizer Investigational Site
      • Las Vegas, Nevada, United States, 89128
        • Pfizer Investigational Site
      • Las Vegas, Nevada, United States, 89109
        • Pfizer Investigational Site
    • New York
      • New York, New York, United States, 10021
        • Pfizer Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Pfizer Investigational Site
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Study Completion (Actual)

August 1, 2004

Study Registration Dates

First Submitted

February 12, 2003

First Submitted That Met QC Criteria

February 12, 2003

First Posted (Estimate)

February 13, 2003

Study Record Updates

Last Update Posted (Estimate)

May 7, 2007

Last Update Submitted That Met QC Criteria

May 4, 2007

Last Verified

July 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RTKC-0511-014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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