TRIAL DETAIL

Imatinib Mesylate (Gleevec; STI571) in Treating Patients With Primary Gastrointestinal Stromal Tumor That Has Been Completely Removed by Surgery (ACOSOG-Z9001)

Drug:
Trial Name:
Imatinib Mesylate (Gleevec; STI571) in Treating Patients With Primary Gastrointestinal Stromal Tumor That Has Been Completely Removed by Surgery (ACOSOG-Z9001)
NCT#:
Conditions:
Gastrointestinal Stromal Tumor
Status:
Completed
Phase:
3
Start Date 06/01/2002
Age of Trial (yrs) 18.2
Treatment Phase:
Adjuvant
Drug Category:
KIT/PDGFRA inhibitor
Strategy:
Block KIT
Trial Type:
Specifically GIST and only GIST
Other Protocol IDs:
CDR0000069452, ACOSOG-Z9001, CAN-NCIC-SRC1, CALGB-ACOSOG-Z9001, SWOG-ACOSOG-Z9001, UWCC-UW-6303, UWCC-UW-03-8438-A-03
Sponsor:
ACS, NCI, NCIC, CALGB, SWOG
Patient Contact:
Contact email:
Contact Phone:
Randomized:
Randomized
IV or Oral:
Oral
Trial Notes:
This randomized trial (Z9001) compared patients taking imatinib (Gleevec) for one year after complete surgical removal of a primary tumor, to the same patient group that did not receive imatinib.
On December 19th, 2008, the FDA approved adjuvant imatinib (preventative) for patients in the United States based on the results of this trial (results will continue to be updated as the trial matures). On May 7, 2009, imatinib received approval from the European Commission (EC) for adjuvant treatment of GIST.
Patients assigned to the Gleevec arm had a recurrence-free survival (RFS) of 97% at the one year mark compared to 83% RFS for the patients on placebo.
Patients will continue to be followed by protocol for up to 10 years. Note however, that patients in the imatinibĀ  arm AND the placebo arm may have taken imatinib after their active trial participation thus making the results more difficult to interpret.

Trial Links

Trial Results

 
 
 
 
 
 
 

Drug Information

All About Gleevec (LRG website)
 
Gleevec prescribing information
 
Patient assistance program (insurance, financial help, etc).
 
Gleevec blood level monitoring (LRG story/info)
 
Gleevec drug interactions (LRG site)
 
Gleevec.com website (GIST portion)
 
FDA approves adjuvant Gleevec
 
Effect of a proton pump inhibitor on the pharmacokinetics of imatinib
 
Imatinib Mesylate May Improve Fasting Blood Glucose in Diabetic Ph+ Chronic Myelogenous Leukemia Patients Responsive to Treatment
 
European Commission approves new label for Novartis drug GlivecĀ® extending adjuvant therapy to three years for certain GIST patients
 
Disintegration of chemotherapy tablets (including imatinib) for oral administration in patients with swallowing difficulties
 
Imatinib-induced hyperbilirubinemia with UGT1A1 (*28) promoter polymorphism: first case series in patients with gastrointestinal stromal tumor.
 

Trial Sites

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