A Study To Assess The Safety And Efficacy Of SU11248 In Patients With Gastrointestinal Stromal Tumor(GIST)
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00075218
First received: January 6, 2004
Last updated: August 31, 2009
Last verified: August 2009
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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:
Genetics Home Reference related topics:
gastrointestinal stromal tumor
MedlinePlus related topics:
Cancer
U.S. FDA Resources
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00075218
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Hide Study LocationsLocations
| 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, 98109 | |
| Pfizer Investigational Site | |
| Seattle, Washington, United States, 98195 | |
| 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, 20141 | |
| Pfizer Investigational Site | |
| Milano, Italy, 20162 | |
| Pfizer Investigational Site | |
| Milano, Italy, 20133 | |
| 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 |
| 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 Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Sunitinib |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013