TRIAL DETAIL

Prospective Multicentric Randomized Study of Glivec® in Advanced Gastrointestinal Stromal Tumors Expressing c-Kit: Interruption After 5 Years vs Maintenance

Drug:
Trial Name:
Prospective Multicentric Randomized Study of Glivec® in Advanced Gastrointestinal Stromal Tumors Expressing c-Kit: Interruption After 5 Years vs Maintenance
NCT#:
Conditions:
Gastrointestinal Stromal Tumor
Status:
Completed
Phase:
3
Start Date 05/01/2002
Age of Trial (yrs) 19.6
Treatment Phase:
First-line
Drug Category:
KIT/PDGFRA inhibitor
Strategy:
Block KIT
Trial Type:
Specifically GIST and only GIST
Other Protocol IDs:
CST1571BFR14, ET2002-021
Sponsor:
Centre Leon Berard, Institut Gustave Roussy
Patient Contact:
Jean Yves Blay, M.D, Ph.D
Contact email:
blay@lyon.fnclcc.fr
Contact Phone:
33607507064
Randomized:
Randomized
IV or Oral:
Oral
Trial Notes:
Virtually all malignant GISTs actually harbor activating mutations of the KIT pathway in the tumor cells, leading to ligand-independent activation of KIT tyrosine kinase activity and tumor growth in vitro. Glivec® inhibits KIT and exerts a major antitumor efficacy in vivo in patients with advanced GIST. Glivec® is generally pursued until progression or intolerance. The optimal duration of treatment with Glivec® remains unknown. The objective of this study is to determine the feasability of Glivec® treatment interuption with reintroduction at progression in GIST patients.

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
 
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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 Glivec® 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

Name
Address
City
State
Zip
Country
28 rue Laennec
Lyon
Rhone
69373
France
Villejuif
Val de Narne
94805
France
Lyon
69008
France
Lille
Nord
59020
France
229 Cours Argonne
Bordeaux
Gironde
33076
France
Marseilles
13273
France
Nancy
57000
France
Marseille
13000
France