A Treatment Protocol For Patients Continuing From A Prior SU011248 Protocol.

April 2, 2013 updated by: Pfizer
This protocol allows subjects who have participated in a previous SU011248 protocol the ability to continue to receive SU011248 after their study has ended.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

123

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

    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Pfizer Investigational Site
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Pfizer Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H3G 1A4
        • Pfizer Investigational Site
      • Montreal, Quebec, Canada, H2L 4M1
        • Pfizer Investigational Site
      • Montreal, Quebec, Canada, H3G 1L5
        • Pfizer Investigational Site
      • Lyon Cedex 08, France, 69373
        • Pfizer Investigational Site
      • Marseille Cedex 20, France, 13915
        • Pfizer Investigational Site
      • Villejuif, France, 94805
        • Pfizer Investigational Site
      • Berlin, Germany, 10117
        • Pfizer Investigational Site
      • Grosshansdorf, Germany, 22927
        • Pfizer Investigational Site
      • Hamburg, Germany, 20246
        • Pfizer Investigational Site
      • Wiesbaden, Germany, 65199
        • Pfizer Investigational Site
      • Bologna, Italy, 40138
        • Pfizer Investigational Site
      • Cremona, Italy, 26100
        • Pfizer Investigational Site
      • Genova, Italy, 16132
        • Pfizer Investigational Site
      • Milano, Italy, 20133
        • Pfizer Investigational Site
      • Orbassano (TO), Italy, 10043
        • Pfizer Investigational Site
      • Rozzano (MI), Italy, 20089
        • Pfizer Investigational Site
      • Barcelona, Spain, 08003
        • Pfizer Investigational Site
      • Cordoba, Spain, 14004
        • Pfizer Investigational Site
    • Alicante
      • Elche, Alicante, Spain, 03203
        • Pfizer Investigational Site
      • London, United Kingdom, SW3 6JJ
        • Pfizer Investigational Site
      • Manchester, United Kingdom, M20 4BX
        • Pfizer Investigational Site
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • Pfizer Investigational Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Pfizer Investigational Site
      • Littleton, Colorado, United States, 80120
        • Pfizer Investigational Site
    • Florida
      • Orlando, Florida, United States, 32806
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Pfizer Investigational Site
    • Illinois
      • Harvey, Illinois, United States, 60426-4265
        • Pfizer Investigational Site
      • Harvey, Illinois, United States, 60426
        • Pfizer Investigational Site
      • Maywood, Illinois, United States, 60153
        • Pfizer Investigational Site
      • Tinley Park, Illinois, United States, 60477
        • Pfizer Investigational Site
      • Zion, Illinois, United States, 60099
        • Pfizer Investigational Site
    • Indiana
      • Munster, Indiana, United States, 46321
        • Pfizer Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Pfizer Investigational Site
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Pfizer Investigational Site
    • Missouri
      • Creve Coeur, Missouri, United States, 63141
        • Pfizer Investigational Site
      • St. Louis, Missouri, United States, 63110
        • Pfizer Investigational Site
      • St. Peters, Missouri, United States, 63376
        • Pfizer Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89135
        • Pfizer Investigational Site
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Pfizer Investigational Site
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7600
        • Pfizer Investigational Site
      • Clinton, North Carolina, United States, 28328
        • Pfizer Investigational Site
      • Goldsboro, North Carolina, United States, 27534
        • Pfizer Investigational Site
      • Hickory, North Carolina, United States, 28602
        • Pfizer Investigational Site
      • Wilson, North Carolina, United States, 27893
        • Pfizer Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Pfizer Investigational Site
      • Tulsa, Oklahoma, United States, 74133
        • Pfizer Investigational Site
      • Tulsa, Oklahoma, United States, 74136
        • Pfizer Investigational Site
      • Tulsa, Oklahoma, United States, 74104
        • Pfizer Investigational Site
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Pfizer Investigational Site
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Pfizer Investigational Site
      • Greer, South Carolina, United States, 29650
        • Pfizer Investigational Site
      • Spartanburg, South Carolina, United States, 29307
        • Pfizer Investigational Site
    • Texas
      • Bedford, Texas, United States, 76022
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75246
        • Pfizer Investigational Site
      • Fort Worth, Texas, United States, 76177
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77030
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78229
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78207
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78217
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78258
        • 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:

  • Participation in a previous SU011248 protocol and are judged by the investigator to have the potential to derive clinical benefit by remaining on SU011248 after the prior protocol ends.

Exclusion Criteria:

  • Severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Administered orally in doses ranging from 25 to 50 mg once daily; dosing schedule and dosage depends on the patients dosing from the prior protocol
Other Names:
  • Sutent/Sunitinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Baseline up to Day 28 after last dose of study treatment
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Baseline up to Day 28 after last dose of study treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Baseline, every 2 months until death or up to 2 years after the last dose of study treatment
Time in weeks from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).
Baseline, every 2 months until death or up to 2 years after the last dose of study treatment
Progression-Free Survival (PFS)
Time Frame: Baseline, every 2 months until objective tumor progression or death or up to 2 years after the last dose of study medication
Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death").
Baseline, every 2 months until objective tumor progression or death or up to 2 years after the last dose of study medication
Time to Tumor Progression (TTP)
Time Frame: Baseline, every 2 months until objective tumor progression or up to 2 years after the last dose of study medication
Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]).
Baseline, every 2 months until objective tumor progression or up to 2 years after the last dose of study medication

Collaborators and Investigators

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

Sponsor

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.

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

May 1, 2006

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

March 2, 2007

First Submitted That Met QC Criteria

March 5, 2007

First Posted (Estimate)

March 6, 2007

Study Record Updates

Last Update Posted (Estimate)

May 24, 2013

Last Update Submitted That Met QC Criteria

April 2, 2013

Last Verified

April 1, 2013

More Information

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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