TRIAL DETAIL

Efficiency of Imatinib Treatment Maintenance or Interruption After 3 Years of Adjuvant Treatment in Patients With Gastrointestinal Stromal Tumours (GIST) (ImadGist)

Drug:
Trial Name:
Efficiency of Imatinib Treatment Maintenance or Interruption After 3 Years of Adjuvant Treatment in Patients With Gastrointestinal Stromal Tumours (GIST) (ImadGist)
NCT#:
Conditions:
Gastrointestinal Stromal Tumor
Status:
Recruiting
Phase:
3
Start Date 12/24/2014
Age of Trial (yrs) 5.6
Treatment Phase:
Adjuvant
Drug Category:
KIT/PDGFRA inhibitor
Strategy:
Block KIT
Trial Type:
Specifically GIST and only GIST
Other Protocol IDs:
IMADGIST 2013-001372-37 ( EudraCT Number )
Sponsor:
Centre Leon Berard
Patient Contact:
Jean-Yves Blay, Pr +33 4 78 78 27 57 jean-yves.blay@lyon.unicancer.fr
Contact email:
Contact Phone:
Randomized:
Randomized
IV or Oral:
Oral
Trial Notes:
This is a 2 arms study concerning patients with primary GIST who followed an Imatinib adjuvant treatment for 3 years after surgery and who have a high risk of recurrence.

In the first arm, patients will continue Imatinib treatment for 3 more years, allowing to determine if the continuation of this treatment is efficient for disease control, in terms of Disease Free Survival improvement.

In the second arm, patients will discontinue the Imatinib treatment, as standard practice. This arm will allow to determine if the re-introduction of Imatinib at relapse is still an efficient treatment for the control of disease.

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 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
Marseille
Bouches du Rhone
13273
France
264 Rue Saint Pierre
Marseille
Bouches du Rhone
13386
France
Besancon
Doubs
25030
France
229 Cours Argonne
Bordeaux
Gironde
33076
France
Paris
Ile de France
75908
France
Saint-Herblain
Loire Atlantique
44805
France
Lille
Nord
59020
France
Saint Priest en Jarez
Loire
42270
France
Reims
Marne
51092
France
Villejuif
Val de Narne
94805
France
Paris
75571
France
Toulouse
Haut-Garonne
31059
France
Montpellier
Herault
34298
France
Vandoeuvre-les-Nancy
Meurthe et Moselle
54519
France
Strasbourg
67098
France
Dijon
21079
France