TRIAL DETAIL

Post-Marketing Clinical Study of Postoperative Adjuvant Therapy With Imatinib Mesylate in Patients With Gastrointestinal Stromal Tumors (GIST) (Japan CSTI571BJP07)

Drug:
Trial Name:
Post-Marketing Clinical Study of Postoperative Adjuvant Therapy With Imatinib Mesylate in Patients With Gastrointestinal Stromal Tumors (GIST) (Japan CSTI571BJP07)
NCT#:
Conditions:
Gastrointestinal Stromal Tumor
Status:
Completed
Phase:
4
Start Date 07/01/2004
Age of Trial (yrs) 16.1
Treatment Phase:
Adjuvant
Drug Category:
KIT/PDGFRA inhibitor
Strategy:
Block KIT
Trial Type:
Specifically GIST and only GIST
Other Protocol IDs:
CSTI571BJP07
Sponsor:
Novartis
Patient Contact:
Novartis Pharma KK      
Contact email:
Contact Phone:
81-3-3797-8748
Randomized:
IV or Oral:
Oral
Trial Notes:
Post-Marketing Clinical Study of Postoperative Adjuvant Therapy With Imatinib Mesylate in Patients With Gastrointestinal Stromal Tumors (GIST)

Further study details as provided by Novartis:

Primary Outcome Measures:

* To evaluate the relapse-free survival (RFS) in patients receiving postoperative adjuvant therapy


Secondary Outcome Measures:

* To evaluate overall survival, relapse free
* Safety


Estimated Enrollment: 60
Study Start Date: July 2004

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
Tokyo
Japan