TRIAL DETAIL

Imatinib Mesylate in Treating Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumor (EORTC-62005)

Drug:
Trial Name:
Imatinib Mesylate in Treating Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumor (EORTC-62005)
NCT#:
Conditions:
Gastrointestinal Stromal Tumor
Status:
Unknown
Phase:
3
Start Date 01/24/2001
Age of Trial (yrs) 23.8
Treatment Phase:
First-line
Drug Category:
KIT/PDGFRA inhibitor
Strategy:
Block KIT
Trial Type:
Specifically GIST and only GIST
Other Protocol IDs:
CDR0000596490, EORTC-62005, AGITG-AGO102-GIST, ISG-62005, SSG-15
Sponsor:
EORTC, ISG, AGTG SSG
Patient Contact:
Contact email:
Contact Phone:
Randomized:
Randomized
IV or Oral:
Oral
Trial Notes:
This is the EORTC phase 3 European, Asian and Australian trial for GIST. This trial recruited 946 patients. It started in early 2001 and finished recruitment by 2003. The trial is ongoing but no longer recruiting patients.
The results of this trial (EORTC 62005), the similar US/Canadian phase 3 trial (S0033) and the phase 2 B2222 trial, form the basis of much of what is known about Gleevec for metastatic GIST today. Links to the "meta-analysis" refer to the combined data from this trial and the S0033 phase 3 trial.

Study Chair: Jacob Verweij, MD, PhD Daniel Den Hoed Cancer Center at Erasmus Medical Center
Study Chair: Paolo G. Casali, MD Fondazione Istituto Nazionale dei Tumori
Study Chair: John R. Zalcberg, MB, BS, PhD, FRACP Peter MacCallum Cancer Centre, Australia
Study Chair: Kirsten Sundby Hall, MD Lund University Hospital

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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