TRIAL DETAIL

Preoperative and Postoperative Imatinib Mesylate Study in Patients With c-Kit Positive GIST (MDACC)

Drug:
Trial Name:
Preoperative and Postoperative Imatinib Mesylate Study in Patients With c-Kit Positive GIST (MDACC)
NCT#:
Conditions:
GIST
Status:
Completed
Phase:
2
Start Date 07/01/2003
Age of Trial (yrs) 17.1
Treatment Phase:
Adjuvant Neoadjuvant
Drug Category:
KIT/PDGFRA inhibitor
Strategy:
Block KIT
Trial Type:
Specifically GIST and only GIST
Other Protocol IDs:
ID03-0023
Sponsor:
MD Anderson, Novartis
Patient Contact:
Jon Trent, MD, PhD
Contact email:
Contact Phone:
713-792-3626
Randomized:
Randomized
IV or Oral:
Oral
Trial Notes:
Primary objectives

1. To determine whether induction of apoptosis or inhibition of angiogenesis are involved in the antitumor activity of Gleevec in patients with GIST as assessed by PET scanning.
2. To determine whether dynamic CT, PET scan, molecular and histopathologic responses in GIST tumors from patients treated with Gleevec predict DFS time.

Secondary objectives

1. To determine the disease free survival of patients with resectable or partially resectable GI stromal tumors treated with Gleevec preoperatively and continued for 2 years after resection of disease.
2. To assess the safety and tolerability of Gleevec given to patients with GI stromal tumors 3, 5, or 7 days preoperatively and continued postoperatively.

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

Name
Address
City
State
Zip
Country
1505 Holcombe Blvd.
Houston
TX
77030
USA