TRIAL DETAIL

Imatinib Mesylate in Treating Patients With Gastrointestinal Stromal Tumor That Has Been Completely Removed During Surgery (Z9000)

Drug:
Trial Name:
Imatinib Mesylate in Treating Patients With Gastrointestinal Stromal Tumor That Has Been Completely Removed During Surgery (Z9000)
NCT#:
Conditions:
Gastrointestinal Stromal Tumor
Status:
Completed
Phase:
2
Start Date 09/27/2001
Age of Trial (yrs) 18.9
Treatment Phase:
Adjuvant
Drug Category:
KIT/PDGFRA inhibitor
Strategy:
Block KIT
Trial Type:
Specifically GIST and only GIST
Other Protocol IDs:
CDR0000068942, ACOSOG-Z9000, CWRU-020313
Sponsor:
ACS NCI
Patient Contact:
Contact email:
Contact Phone:
Randomized:
IV or Oral:
Oral
Trial Notes:
This phase II trial (Z9000) of adjuvant Gleevec enrolled 106 patients beginning in September, 2001. The trial is ongoing but not recruiting new patients.
Patients were given Gleevec for one year and then followed. This trial has some of the longest follow-up of the adjuvant trials and thus some of the better data on what happens to patients after they stop taking imatinib. The Z9001 phase III adjuvant trial had a placebo so it demonstrates the large advantage that Gleevec has in preventing (or delaying) a recurrence; however the follow-up time is not as long.
See the links under trial results.

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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