A Study of Sunitinib In Young Patients With Advanced Gastrointestinal Stromal Tumor
NCT ID: NCT01396148
Last Updated: 2019-03-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
6 participants
INTERVENTIONAL
2012-06-30
2017-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
TREATMENT
NONE
Study Groups
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Children with GIST
children ages 6yrs-\<18yrs
sunitinib malate dose escalation
sunitinib starting dose will be 15mg/m\^2 daily on a 4 weeks on/2 weeks off schedule (Schedule 4/2).
Young adults with GIST
young adults ages 18yrs-\<21 yrs
sunitinib malate
sunitinib 50mg daily on Schedule 4/2
Interventions
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sunitinib malate dose escalation
sunitinib starting dose will be 15mg/m\^2 daily on a 4 weeks on/2 weeks off schedule (Schedule 4/2).
sunitinib malate
sunitinib 50mg daily on Schedule 4/2
Eligibility Criteria
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Inclusion Criteria
* Patients must have demonstrated either disease progression or intolerance to imatinib mesylate, have non-mutant Stem Cell Factor Receptor gene (KIT) GIST, or cannot obtain imatinib in their country
* Measurable by Response Evaluation Criterion in Solid Tumors (RECIST) or evaluable disease.
Exclusion Criteria
* Prior sunitinib treatment.
* Prior therapy with known risk for cardiovascular complications.
6 Years
20 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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Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles
Los Angeles, California, United States
Children's Hospital Boston
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Fakultni nemocnice Brno
Brno, , Czechia
FN Brno
Brno, , Czechia
Masarykuv onkologicky ustav
Brno, , Czechia
CHU de La Timone, Hopital enfants
Marseille, , France
Hopital d'Enfants de la Timone
Marseille, , France
Hopital de la Timone
Marseille, , France
Countries
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References
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Wang E, DuBois SG, Wetmore C, Verschuur AC, Khosravan R. Population Pharmacokinetics of Sunitinib and its Active Metabolite SU012662 in Pediatric Patients with Gastrointestinal Stromal Tumors or Other Solid Tumors. Eur J Drug Metab Pharmacokinet. 2021 May;46(3):343-352. doi: 10.1007/s13318-021-00671-7. Epub 2021 Apr 14.
Verschuur AC, Bajciova V, Mascarenhas L, Khosravan R, Lin X, Ingrosso A, Janeway KA. Sunitinib in pediatric patients with advanced gastrointestinal stromal tumor: results from a phase I/II trial. Cancer Chemother Pharmacol. 2019 Jul;84(1):41-50. doi: 10.1007/s00280-019-03814-5. Epub 2019 Apr 20.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2011-002008-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
A6181196
Identifier Type: -
Identifier Source: org_study_id
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