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A Study To Assess The Safety And Efficacy Of SU11248 In Patients With Gastrointestinal Stromal Tumor(GIST)

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00075218
First received: January 6, 2004
Last updated: August 31, 2009
Last verified: August 2009
  Purpose

A study to assess the safety and efficacy of SU11248 in patients with gastrointestinal stromal tumor (GIST) whose disease has failed imatinib therapy or who were intolerant to imatinib treatment.


Condition Intervention Phase
Gastrointestinal Stromal Tumor
Drug: Placebo
Drug: SU011248
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Of SU011248 In The Treatment Of Patients With Imatinib Mesylate (Gleevec Tm, Glivec)-Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Time to Tumor Progression (TTP) as Assessed by Imaging Studies at End of Double-blind Treatment Phase [ Time Frame: Day 28 of each 6-week cycle : duration of double-blind treatment phase ] [ Designated as safety issue: No ]
  • Time to Tumor Progression (TTP) as Assessed in the Double-blind Treatment Phase at End of Study [ Time Frame: Day 28 of each 6-week cycle : duration of double-blind treatment phase after Last Subject Last Visit (LSLV) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: Day 28 of each cycle : duration of double-blind treatment phase ] [ Designated as safety issue: No ]
  • Overall Survival Status of Subjects [ Time Frame: clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug ] [ Designated as safety issue: No ]
  • Overall Survival Based on the Rank Preserving Structural Failure Time Method [ Time Frame: clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug ] [ Designated as safety issue: No ]
  • Best Overall Tumor Response During Double-blind Treatment Phase [ Time Frame: Day 28 of each cycle : duration of double-blind treatment phase ] [ Designated as safety issue: No ]
  • Confirmed Objective Response (CR or PR) in Subjects [ Time Frame: Day 28 of each cycle : duration of double-blind treatment phase ] [ Designated as safety issue: No ]
  • Time to Tumor Response (TTR) [ Time Frame: Day 28 of each cycle : duration of double-blind treatment phase ] [ Designated as safety issue: No ]
  • Duration of Performance Status Maintenance [ Time Frame: Day 28 of each cycle : duration of double-blind treatment phase ] [ Designated as safety issue: No ]
  • Time to Pain Progression Using McGill Pain Questionnaire-present Pain Intensity (MPQ-PPI) [ Time Frame: Day 1 & 28 of each cycle : duration of double-blind treatment phase ] [ Designated as safety issue: No ]
  • Subjects With Pain Relief Response Using McGill Pain Questionnaire-present Pain Intensity (MPQ-PPI) [ Time Frame: Day 1 & 28 of each cycle : duration of double-blind treatment phase ] [ Designated as safety issue: No ]
  • Change From Baseline Score in EuroQoL Visual Analog Scale (EQ-VAS) [ Time Frame: Day 1 & 28 of each cycle : duration of double-blind treatment phase ] [ Designated as safety issue: No ]
  • Change From Baseline in EQ-5D Health State Profile Index [ Time Frame: Day 1 & 28 of each cycle : duration of double-blind treatment phase ] [ Designated as safety issue: No ]

Enrollment: 361
Study Start Date: December 2003
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: B Drug: Placebo
50 mg taken orally once a day. 6 week treatment cycle (Schedule 4/2) 4 weeks on study drug/2 weeks off study drug.
Active Comparator: A Drug: SU011248
50 mg taken orally once a day. 6 week treatment cycle (Schedule 4/2) 4 weeks on study drug/2 weeks off study drug.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Histologically-proven diagnosis of malignant GIST not amenable to surgery, radiation or combined modality treatment with curative intent
  • Failed Gleevec treatment or intolerant to Gleevec therapy

Key Exclusion Criteria:

  • Treatment with any chemotherapy, chemoembolization therapy, immunotherapy, or investigational agent since the last dose of Gleevec
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00075218

  Hide Study Locations
Locations
United States, California
Pfizer Investigational Site
Duarte, California, United States, 91010
Pfizer Investigational Site
Los Angeles, California, United States, 90095
Pfizer Investigational Site
Los Angeles, California, United States, 90095-6984
Pfizer Investigational Site
Pasadena, California, United States, 91105
Pfizer Investigational Site
Santa Monica, California, United States, 90404
Pfizer Investigational Site
Stanford, California, United States, 94305
United States, District of Columbia
Pfizer Investigational Site
Washington, District of Columbia, United States, 20010
United States, Florida
Pfizer Investigational Site
Miami, Florida, United States, 33136
Pfizer Investigational Site
Tampa, Florida, United States, 33612
United States, Illinois
Pfizer Investigational Site
Park Ridge, Illinois, United States, 60068
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02115
United States, Michigan
Pfizer Investigational Site
Detroit, Michigan, United States, 48201
United States, Minnesota
Pfizer Investigational Site
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Pfizer Investigational Site
St. Louis, Missouri, United States, 63110
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10032
Pfizer Investigational Site
New York, New York, United States, 10021-6007
Pfizer Investigational Site
New York, New York, United States, 10022
United States, North Carolina
Pfizer Investigational Site
Durham, North Carolina, United States, 27710
United States, Ohio
Pfizer Investigational Site
Cleveland, Ohio, United States, 44195-0002
Pfizer Investigational Site
Columbus, Ohio, United States, 43210
Pfizer Investigational Site
Columubs, Ohio, United States, 43210
United States, Oregon
Pfizer Investigational Site
Portland, Oregon, United States, 97201
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19111
United States, Tennessee
Pfizer Investigational Site
Nashville, Tennessee, United States, 37232
United States, Washington
Pfizer Investigational Site
Seattle, Washington, United States, 98195
Pfizer Investigational Site
Seattle, Washington, United States, 98109
United States, Wisconsin
Pfizer Investigational Site
Madison, Wisconsin, United States, 53792-0001
Australia, Australian Capital Territory
Pfizer Investigational Site
Garran, Australian Capital Territory, Australia, 2605
Australia, New South Wales
Pfizer Investigational Site
Camperdown, New South Wales, Australia, 2050
Pfizer Investigational Site
Randwick, New South Wales, Australia, 2031
Australia, Queensland
Pfizer Investigational Site
Auchenflower, Queensland, Australia, 4066
Australia, South Australia
Pfizer Investigational Site
Ashford, South Australia, Australia, 5035
Pfizer Investigational Site
Bedford Park, South Australia, Australia, 5042
Australia, Victoria
Pfizer Investigational Site
East Melbourne, Victoria, Australia, 3002
Belgium
Pfizer Investigational Site
Leuven, Belgium, 3000
Canada, Ontario
Pfizer Investigational Site
Toronto, Ontario, Canada, M5G 1X5
Canada, Quebec
Pfizer Investigational Site
Montreal, Quebec, Canada, H2L 4M1
France
Pfizer Investigational Site
Lyon, France, 69373
Pfizer Investigational Site
Marseille, France, 13385
Pfizer Investigational Site
VILLEJUIF Cedex, France, 94805
Italy
Pfizer Investigational Site
Aviano, PN, Italy, 33081
Pfizer Investigational Site
Candiolo, Torino, Italy, 10060
Pfizer Investigational Site
Bologna, Italy, 40138
Pfizer Investigational Site
Genova, Italy, 16132
Pfizer Investigational Site
Milano, Italy, 20133
Pfizer Investigational Site
Milano, Italy, 20162
Pfizer Investigational Site
Milano, Italy, 20141
Pfizer Investigational Site
Torino, Italy, 10153
Netherlands
Pfizer Investigational Site
Groningen, Gr, Netherlands, 9713 GZ
Pfizer Investigational Site
Rotterdam, ZH, Netherlands, 3075 EA
Singapore
Pfizer Investigational Site
Singapore, Singapore, 308433
Pfizer Investigational Site
Singapore, Singapore, 119074
Pfizer Investigational Site
Singapore, Singapore, 169610
Spain
Pfizer Investigational Site
L'Hospitalet del Llobregat, Barcelona, Spain, 08907
Pfizer Investigational Site
Barcelona, Spain, 08025
Pfizer Investigational Site
Madrid, Spain, 28041
Switzerland
Pfizer Investigational Site
Lausanne, Switzerland, CH-1011
United Kingdom
Pfizer Investigational Site
Sutton, Surrey, United Kingdom, SM2 5NG
Pfizer Investigational Site
Leeds, United Kingdom, LS9 7TF
Pfizer Investigational Site
London, United Kingdom, W1T 3AA
Pfizer Investigational Site
Newcastle-Upon-Tyne, United Kingdom, NE4 6BE
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00075218     History of Changes
Obsolete Identifiers: NCT00085618
Other Study ID Numbers: A6181004
Study First Received: January 6, 2004
Results First Received: May 6, 2009
Last Updated: August 31, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue

ClinicalTrials.gov processed this record on November 20, 2014