TRIAL DETAIL

Efficiency of Imatinib Treatment After 10 Years of Treatment in Patients With Gastrointestinal Stromal Tumours (GIST) (Gist-Ten)

Drug:
Trial Name:
Efficiency of Imatinib Treatment After 10 Years of Treatment in Patients With Gastrointestinal Stromal Tumours (GIST) (Gist-Ten)
NCT#:
Conditions:
Gastrointestinal Stromal Tumor
Status:
Not yet recruiting
Phase:
2
Start Date 10/30/2021
Age of Trial (yrs) .6
Treatment Phase:
First-line
Drug Category:
KIT/PDGFRA inhibitor
Strategy:
Block KIT
Trial Type:
Specifically GIST and only GIST
Other Protocol IDs:
GIST-TEN
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:
Criteria

Inclusion Criteria:

Patients ≥18 years of age;
Histologically documented diagnosis of malignant advanced/metastatic GIST with immunohistochemical documentation of c-kit (CD117) expression either by the primary tumor or metastases;
Eastern Cooperative Oncology Group (ECOG) - Performance status (PS) 0 to 2 evaluated within 7 days prior to the date of inclusion.
Patient must be under imatinib treatment (at 300 or 400mg/day) maintained for 10 years or over with no more than 12 months in total or 3 consecutive months of interruption during the treatment period;
Patient with controlled disease (without any progression under imatinib);
Willingness and ability to comply with scheduled visits, treatment plans , laboratory tests, and other study procedures;
Covered by a medical/health insurance;
Signed and dated informed consent document indicating that the patient has been informed of all aspects of the trial prior to enrolment.

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
229 Cours Argonne
Bordeaux
Gironde
33076
France
28 rue Laennec
Lyon
Rhone
69373
France
Marseille
Bouches du Rhone
13273
France
Paris
75005
France
Reimes
France
Saint-Herblain
Loire Atlantique
44805
France
Toulouse
Haut-Garonne
31059
France
Vandoeuvre-les-Nancy
Meurthe et Moselle
54519
France
Villejuif
Val de Narne
94805
France
Besancon
Doubs
25030
France
Rennes
35042
France
Saint Priest en Jarez
Loire
42270
France