Safety And Efficacy Study Of Sunitinib Malate In Chinese Patients With Imatinib Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor
NCT ID: NCT00793871
Last Updated: 2015-11-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
60 participants
INTERVENTIONAL
2008-11-30
2014-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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sunitinib
single agent sunitinib, single arm
Sunitinib Malate (SU011248)
Subjects will receive treatment with sunitinib in repeated 6-week cycles (4 weeks on, 2 weeks off), at a starting dose of 50 mg.
Interventions
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Sunitinib Malate (SU011248)
Subjects will receive treatment with sunitinib in repeated 6-week cycles (4 weeks on, 2 weeks off), at a starting dose of 50 mg.
Eligibility Criteria
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Inclusion Criteria
* Evidence of unidimensionally measurable disease
* Failure of prior treatment with imatinib or intolerant to imatinib
* Male or female, 18 years of age or older.
* ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1.
* Resolution of all acute toxic effects
* Adequate organ function.
Exclusion Criteria
* Major surgery within 4 weeks or radiation therapy within 2 weeks.
* Grade 3 hemorrhage within 4 weeks prior to starting the study treatment.
* Diagnosis of second malignancy within the last 5 years.
* History of brain disease.
* Cardiac disease within 12 months.
* Thyroid function abnormality.
* Ongoing cardiac dysrhythmias.
* Uncontrolled hypertension.
* Ongoing treatment with anticoagulant and CYP3A4 inhibitors and inducers.
* HIV or AIDS related illness.
* Pregnancy or breastfeeding.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Nanjing Bayi Hospital
Nanjing, Jiangsu, China
Cancer Institute & Hospital Chinese Academy of Medical Sciences and PUMC
Beijing, , China
Beijing Cancer Hospital
Beijing, , China
307 Hospital of PLA
Beijing, , China
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A6181177
Identifier Type: -
Identifier Source: org_study_id