TRIAL DETAIL

Imatinib TDM (Therapeutic Drug Monitoring) in GIST

Drug:
Trial Name:
Imatinib TDM (Therapeutic Drug Monitoring) in GIST
NCT#:
Conditions:
Gastrointestinal Stromal Tumor
Status:
Not yet recruiting
Phase:
2
Start Date 09/01/2022
Age of Trial (yrs) 1.8
Treatment Phase:
First-line Adjuvant
Drug Category:
KIT/PDGFRA inhibitor
Strategy:
Block KIT
Trial Type:
Specifically GIST and only GIST
Other Protocol IDs:
MCC-22-GI-123
Sponsor:
Reema A. Patel, MD, University of Kentucky
Patient Contact:
Yvonne A Taul, RN 859-323-2354 Yvonne.Taul@uky.edu
Contact email:
Contact Phone:
Randomized:
IV or Oral:
Oral
Trial Notes:
Brief Summary:

Imatinib can lead to long recurrence free survival in patients diagnosed with gastrointestinal stromal tumors (GIST); however side effects can significantly hinder quality of life for our patients. This study will use therapeutic drug monitoring to improve quality of life and symptoms and assess how many patients maintain therapeutic levels. Free drug levels and pharmokinetics of imatinib will also be monitored.

Inclusion Criteria:

Histologically or cytologically confirmed GIST with KIT mutation or PDGFRA mutation (non-D842V)
Currently receiving imatinib initiated within the last 3 months or to be started in the next 1 month
Prior systemic chemotherapy for other malignancy is allowed as long as it was completed within the past 6 months and there is no evidence of disease
Age ≥18 years
ECOG performance status of 0 or 1
Normal organ function

Exclusion Criteria:

Presence of PDGFRA D842V mutation
Known allergy to imatinib or allergic reactions to compounds of similar chemical or biologic composition to the study drug
Concomitant anticoagulation with oral warfarin.
Use of strong inhibitors or inducers of CYP3A or CYP3A4, drugs metabolized by CYP3A4 or CYP2D6
Uncontrolled intercurrent illness
Concurrent malignancy

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
800 Rose St.
Lexington
KY
40536
USA