TRIAL DETAIL
A Study of Sunitinib In Young Patients With Advanced Gastrointestinal Stromal Tumor
Drug: |
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Trial Name: |
A Study of Sunitinib In Young Patients With Advanced Gastrointestinal Stromal Tumor |
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NCT#: |
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Conditions: |
Gastrointestinal Stromal Tumor |
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Status: |
Completed |
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Phase: |
2 |
Start Date 01/01/2012 |
Age of Trial (yrs) 12.9 |
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Treatment Phase: |
Gleevec-resistant |
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Drug Category: |
KIT/PDGFRA inhibitor |
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Strategy: |
Block KIT |
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Trial Type: |
Specifically GIST and only GIST |
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Other Protocol IDs: |
A6181196 |
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Sponsor: |
Pfizer |
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Patient Contact: |
Pfizer CT.gov Call Center
1-800-718-1021
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Contact email: |
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Contact Phone: |
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Randomized: |
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IV or Oral: |
Oral |
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Trial Notes: |
Check the listing at clinicaltrials.gov for a full list of sites. Offficial Title: A Phase 1/2 Study Of Sunitinib In Young Patients With Advanced Gastrointestinal Stromal Tumor Patients with Stem Cell Factor Receptor gene (KIT)-mutant GIST must have demonstrated either disease progression or intolerance to imatinib mesylate. Children and young adults with gastrointestinal stromal tumors (GIST) will be treated with sunitinib. The safety (including pharmacokinetics) and tolerability of sunitinib will be studied in these patients. In addition, tumor responses and overall survival will be assessed Children ages 6yrs-<18yrs Drug: sunitinib malate dose escalation: starting dose will be 15mg/m2 daily on a 4 weeks on/2 weeks off schedule (Schedule 4/2). Young adults ages 18yrs-<21 yrs sunitinib 50mg daily on Schedule 4/2 |
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Trial Links |
Trial Results |
Trial Sites
Name |
Address |
City |
State |
Zip |
Country |
450 Brookline Ave |
Boston |
MA |
02215-5450 |
USA |
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Boston |
MA |
02115 |
USA |