Rollover Protocol for Prior SU011248 Protocols

December 13, 2012 updated by: Pfizer

A Treatment Protocol For Patients Continuing From A Prior SU011248 Protocol

The objective of this protocol is to provide SU011248 treatment for patients who have participated in a SU011248 protocol and are eligible to enter this protocol

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

314

Phase

  • Not Applicable

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

  • Australia
    • New South Wales
      • Randwick, New South Wales, Australia, 2031
        • Pfizer Investigational Site
    • Victoria
      • East Melbourne, Victoria, Australia, 3002
        • Pfizer Investigational Site
      • Heidelberg, Victoria, Australia, 3084
        • Pfizer Investigational Site
  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2L 4M1
        • Pfizer Investigational Site
  • France
      • Villejuif Cedex, France, 94805
        • Pfizer Investigational Site
  • Greece
      • Thessaloniki, Greece, 564 03
        • Pfizer Investigational Site
  • Italy
      • Milano, Italy, 20133
        • Pfizer Investigational Site
      • Milano, Italy, 20141
        • Pfizer Investigational Site
  • Netherlands
    • Gld
      • Nijmegen, Gld, Netherlands, 6525 GA
        • Pfizer Investigational Site
  • Singapore
      • Singapore, Singapore, 308433
        • Pfizer Investigational Site
  • Sweden
      • Lund, Sweden
        • Pfizer Investigational Site
      • Stockholm, Sweden
        • Pfizer Investigational Site
  • Switzerland
      • St. Gallen, Switzerland, CH-9007
        • Pfizer Investigational Site
  • United Kingdom
      • Leeds, United Kingdom, LS9 7TF
        • Pfizer Investigational Site
      • London, United Kingdom, SW3 6JJ
        • Pfizer Investigational Site
      • London, United Kingdom, NW1 2PG
        • Pfizer Investigational Site
      • Newcastle-Upon-Tyne, United Kingdom, NE4 6BE
        • Pfizer Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Pfizer Investigational Site
      • Birmingham, Alabama, United States, 35294
        • Pfizer Investigational Site
      • Birmingham, Alabama, United States, 35233-2115
        • Pfizer Investigational Site
    • California
      • Los Angeles, California, United States, 90095
        • Pfizer Investigational Site
      • Los Angeles, California, United States, 90033
        • Pfizer Investigational Site
      • San Francisco, California, United States, 94115
        • Pfizer Investigational Site
      • San Francisco, California, United States, 94115-1705
        • Pfizer Investigational Site
      • Santa Monica,, California, United States, 90404
        • Pfizer Investigational Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Pfizer Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Pfizer Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Pfizer Investigational Site
      • Boston, Massachusetts, United States, 02115
        • Pfizer Investigational Site
      • Boston, Massachusetts, United States, 02215
        • Pfizer Investigational Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-0843
        • Pfizer Investigational Site
      • Detroit, Michigan, United States, 48201
        • Pfizer Investigational Site
      • Farmington Hills, Michigan, United States, 48334
        • Pfizer Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455-0392
        • Pfizer Investigational Site
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Pfizer Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131-0001
        • Pfizer Investigational Site
      • Albuqurque, New Mexico, United States, 87106
        • Pfizer Investigational Site
    • New York
      • New York, New York, United States, 10021
        • Pfizer Investigational Site
      • New York, New York, United States, 10032
        • Pfizer Investigational Site
      • New York, New York, United States, 10022
        • Pfizer Investigational Site
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Pfizer Investigational Site
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Pfizer Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Pfizer Investigational Site
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Pfizer Investigational Site
    • Tennessee
      • Franklin, Tennessee, United States, 37067
        • Pfizer Investigational Site
      • Gallatin, Tennessee, United States, 37066
        • Pfizer Investigational Site
      • Hermitage, Tennessee, United States, 37076
        • Pfizer Investigational Site
      • Lebanon, Tennessee, United States, 37087
        • Pfizer Investigational Site
      • Murfreesboro, Tennessee, United States, 37130
        • Pfizer Investigational Site
      • Nashville, Tennessee, United States, 37203
        • Pfizer Investigational Site
      • Nashville, Tennessee, United States, 37232
        • Pfizer Investigational Site
      • Nashville, Tennessee, United States, 37205
        • Pfizer Investigational Site
      • Nashville, Tennessee, United States, 37207
        • Pfizer Investigational Site
      • Nashville, Tennessee, United States, 37211
        • Pfizer Investigational Site
      • Nashville, Tennessee, United States, 37212
        • Pfizer Investigational Site
      • Smyrna, Tennessee, United States, 37167
        • Pfizer Investigational Site
    • Texas
      • Dallas, Texas, United States, 75246
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77030-4009
        • 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:

  • Prior SU011248 Protocol.
  • Eligible to continue SU011248 treatment.

Exclusion Criteria:

  • Uncontrolled CNS metastasis.
  • Unfit to receive SU011248.

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Sunitinib
Drug: Sunitinib
Sunitinib dose varies according to the doses allowed in previous protocol. It is given once a day, orally with various schedules depending on the parent protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Duration of Treatment
Time Frame: Baseline up to Day 28 after last dose of study treatment
Baseline up to Day 28 after last dose of study treatment

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.

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

March 1, 2004

Primary Completion (ACTUAL)

December 1, 2011

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

November 25, 2008

First Submitted That Met QC Criteria

November 25, 2008

First Posted (ESTIMATE)

November 26, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

January 21, 2013

Last Update Submitted That Met QC Criteria

December 13, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A6181030

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.

Subscribe