TRIAL DETAIL
Post Marketing Surveillance Study To Observe Safety And Efficacy Of Sutent
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Trial Name: |
Post Marketing Surveillance Study To Observe Safety And Efficacy Of Sutent |
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NCT#: |
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Conditions: |
Gastrointestinal Stromal Tumors; Carcinoma, Renal Cell |
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Status: |
Invitation Only |
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Phase: |
4 |
Start Date 01/01/2008 |
Age of Trial (yrs) 16.9 |
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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 plus other cancers |
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Other Protocol IDs: |
A6181146 |
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Sponsor: |
Pfizer |
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Patient Contact: |
Pfizer CTgov Call Center
1-800-718-1021
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Contact email: |
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Randomized: |
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IV or Oral: |
Oral |
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Trial Notes: |
This study is enrolling patients by invitation only. May only be available in South Korea. Primary Outcome Measures: * To monitor use in real practice including adverse events on SUTENE capsules (Sunitinib malate) [ Time Frame: 6 years ] [ Designated as safety issue: Yes ] Secondary Outcome Measures: * Efficacy [ Time Frame: 6 years ] [ Designated as safety issue: No ] Biospecimen Retention: None Retained Biospecimen Description: Estimated Enrollment: 3000 Study Start Date: January 2008 Estimated Study Completion Date: June 2012 Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure) |
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