TRIAL DETAIL
Post-Marketing Clinical Study of Postoperative Adjuvant Therapy With Imatinib Mesylate in Patients With Gastrointestinal Stromal Tumors (GIST) (Japan CSTI571BJP07)
Drug: |
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Trial Name: |
Post-Marketing Clinical Study of Postoperative Adjuvant Therapy With Imatinib Mesylate in Patients With Gastrointestinal Stromal Tumors (GIST) (Japan CSTI571BJP07) |
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NCT#: |
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Conditions: |
Gastrointestinal Stromal Tumor |
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Status: |
Completed |
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Phase: |
4 |
Start Date 07/01/2004 |
Age of Trial (yrs) 20.4 |
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Treatment Phase: |
Adjuvant |
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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: |
CSTI571BJP07 |
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Sponsor: |
Novartis |
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Patient Contact: |
Novartis Pharma KK |
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Contact email: |
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Contact Phone: |
81-3-3797-8748 |
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Randomized: |
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IV or Oral: |
Oral |
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Trial Notes: |
Post-Marketing Clinical Study of Postoperative Adjuvant Therapy With Imatinib Mesylate in Patients With Gastrointestinal Stromal Tumors (GIST) Further study details as provided by Novartis: Primary Outcome Measures: * To evaluate the relapse-free survival (RFS) in patients receiving postoperative adjuvant therapy Secondary Outcome Measures: * To evaluate overall survival, relapse free * Safety Estimated Enrollment: 60 Study Start Date: July 2004 |
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Trial Links |
Trial Results |
Trial Sites
Name |
Address |
City |
State |
Zip |
Country |
Tokyo |
Japan |