- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00443534
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
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
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Alberta
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Edmonton, Alberta, Canada, T6G 1Z2
- Pfizer Investigational Site
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Ontario
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Ottawa, Ontario, Canada, K1H 8L6
- Pfizer Investigational Site
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Quebec
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Montreal, Quebec, Canada, H3G 1A4
- Pfizer Investigational Site
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Montreal, Quebec, Canada, H2L 4M1
- Pfizer Investigational Site
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Montreal, Quebec, Canada, H3G 1L5
- Pfizer Investigational Site
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Lyon Cedex 08, France, 69373
- Pfizer Investigational Site
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Marseille Cedex 20, France, 13915
- Pfizer Investigational Site
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Villejuif, France, 94805
- Pfizer Investigational Site
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Berlin, Germany, 10117
- Pfizer Investigational Site
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Grosshansdorf, Germany, 22927
- Pfizer Investigational Site
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Hamburg, Germany, 20246
- Pfizer Investigational Site
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Wiesbaden, Germany, 65199
- Pfizer Investigational Site
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Bologna, Italy, 40138
- Pfizer Investigational Site
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Cremona, Italy, 26100
- Pfizer Investigational Site
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Genova, Italy, 16132
- Pfizer Investigational Site
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Milano, Italy, 20133
- Pfizer Investigational Site
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Orbassano (TO), Italy, 10043
- Pfizer Investigational Site
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Rozzano (MI), Italy, 20089
- Pfizer Investigational Site
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Barcelona, Spain, 08003
- Pfizer Investigational Site
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Cordoba, Spain, 14004
- Pfizer Investigational Site
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Alicante
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Elche, Alicante, Spain, 03203
- Pfizer Investigational Site
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London, United Kingdom, SW3 6JJ
- Pfizer Investigational Site
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Manchester, United Kingdom, M20 4BX
- Pfizer Investigational Site
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Surrey
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Sutton, Surrey, United Kingdom, SM2 5PT
- Pfizer Investigational Site
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Colorado
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Aurora, Colorado, United States, 80045
- Pfizer Investigational Site
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Littleton, Colorado, United States, 80120
- Pfizer Investigational Site
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Florida
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Orlando, Florida, United States, 32806
- Pfizer Investigational Site
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Georgia
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Atlanta, Georgia, United States, 30322
- Pfizer Investigational Site
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Illinois
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Harvey, Illinois, United States, 60426-4265
- Pfizer Investigational Site
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Harvey, Illinois, United States, 60426
- Pfizer Investigational Site
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Maywood, Illinois, United States, 60153
- Pfizer Investigational Site
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Tinley Park, Illinois, United States, 60477
- Pfizer Investigational Site
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Zion, Illinois, United States, 60099
- Pfizer Investigational Site
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Indiana
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Munster, Indiana, United States, 46321
- Pfizer Investigational Site
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Maryland
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Baltimore, Maryland, United States, 21201
- Pfizer Investigational Site
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Michigan
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Grand Rapids, Michigan, United States, 49503
- Pfizer Investigational Site
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Missouri
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Creve Coeur, Missouri, United States, 63141
- Pfizer Investigational Site
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St. Louis, Missouri, United States, 63110
- Pfizer Investigational Site
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St. Peters, Missouri, United States, 63376
- Pfizer Investigational Site
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Nevada
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Las Vegas, Nevada, United States, 89135
- Pfizer Investigational Site
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New Jersey
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Hackensack, New Jersey, United States, 07601
- Pfizer Investigational Site
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North Carolina
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Chapel Hill, North Carolina, United States, 27599-7600
- Pfizer Investigational Site
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Clinton, North Carolina, United States, 28328
- Pfizer Investigational Site
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Goldsboro, North Carolina, United States, 27534
- Pfizer Investigational Site
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Hickory, North Carolina, United States, 28602
- Pfizer Investigational Site
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Wilson, North Carolina, United States, 27893
- Pfizer Investigational Site
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73120
- Pfizer Investigational Site
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Tulsa, Oklahoma, United States, 74133
- Pfizer Investigational Site
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Tulsa, Oklahoma, United States, 74136
- Pfizer Investigational Site
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Tulsa, Oklahoma, United States, 74104
- Pfizer Investigational Site
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Pennsylvania
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Hershey, Pennsylvania, United States, 17033
- Pfizer Investigational Site
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South Carolina
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Greenville, South Carolina, United States, 29615
- Pfizer Investigational Site
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Greer, South Carolina, United States, 29650
- Pfizer Investigational Site
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Spartanburg, South Carolina, United States, 29307
- Pfizer Investigational Site
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Texas
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Bedford, Texas, United States, 76022
- Pfizer Investigational Site
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Dallas, Texas, United States, 75246
- Pfizer Investigational Site
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Fort Worth, Texas, United States, 76177
- Pfizer Investigational Site
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Houston, Texas, United States, 77030
- Pfizer Investigational Site
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San Antonio, Texas, United States, 78229
- Pfizer Investigational Site
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San Antonio, Texas, United States, 78207
- Pfizer Investigational Site
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San Antonio, Texas, United States, 78217
- Pfizer Investigational Site
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San Antonio, Texas, United States, 78258
- Pfizer Investigational Site
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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 |
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Experimental: 1
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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
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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.
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Baseline up to Day 28 after last dose of study treatment
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Overall Survival (OS)
Time Frame: Baseline, every 2 months until death or up to 2 years after the last dose of study treatment
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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).
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Baseline, every 2 months until death or up to 2 years after the last dose of study treatment
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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
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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").
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Baseline, every 2 months until objective tumor progression or death or up to 2 years after the last dose of study medication
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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
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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]).
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Baseline, every 2 months until objective tumor progression or up to 2 years after the last dose of study medication
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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
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A6181078
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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