TRIAL DETAIL

Five Year Adjuvant Imatinib Mesylate (GleevecĀ®) in Gastrointestinal Stromal Tumor (GIST) (Novartis CSTI571BUS282)

Drug:
Trial Name:
Five Year Adjuvant Imatinib Mesylate (GleevecĀ®) in Gastrointestinal Stromal Tumor (GIST) (Novartis CSTI571BUS282)
NCT#:
Conditions:
Gastrointestinal Stromal Tumor
Status:
Completed
Phase:
2
Start Date 06/01/2009
Age of Trial (yrs) 11.2
Treatment Phase:
Adjuvant
Drug Category:
KIT/PDGFRA inhibitor
Strategy:
Block KIT
Trial Type:
Specifically GIST and only GIST
Other Protocol IDs:
CSTI571BUS282
Sponsor:
Novartis
Patient Contact:
Novartis
Contact email:
Contact Phone:
800-340-6843
Randomized:
IV or Oral:
Oral
Trial Notes:
This is a Phase II, non-randomized, open-label, multi-center study conducted in the USA. The primary endpoint is to evaluate the use of long term adjuvant imatinib mesylate in patients at significant risk for recurrence following complete resection of primary GIST. A total of 133 adult patients, 18 years of age and older will be enrolled.Participants will take 400 mg of imatinib mesylate daily by mouth for a total of 5 years. At the conclusion of the treatment period, patients will be followed for 5 years for survival, status of response, antineoplastic treatments and quality of life.

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
10945 Le Conte Ave.
Los Angeles
CA
90095
USA
La Jolla
CA
92093
USA
8700 Beverly Blvd.
Los Angeles
CA
90048
USA
1665 N. Ursula St.
Aurora
CO
80045
USA
110 Irving St
Washington
DC
20010
USA
Athens
GA
30607
USA
Gainesville
GA
21231
USA
2003 Lincoln Way
Coeur d'Alene
ID
83814
USA
675 North St. Clair
Chicago
IL
60611
USA
2650 Ridge Avenue
Evanston
IL
60201
USA
Iowa City
IA
52242
USA
Baltimore
MD
21231
USA
450 Brookline Ave
Boston
MA
02215-5450
USA
660 S. Euclid Ave
St. Louis
MO
63110
USA
3211 W. Charleston
Las Vegas
NV
89102
USA
Lebanon
NH
03756
USA
1275 York Ave
New York
NY
10065
USA
Bronx
NY
10466
USA
Jamaica
NY
11432
USA
Durham
NC
27705
USA
Medical Center Boulevard
Winston-Salem
NC
27157
USA
Cleveland
OH
44195
USA
333 Cottman Ave
Philadelphia
PA
19111
USA
Hershey
PA
17033
USA
Providence
RI
02908
USA
Kingsport
TN
37660
USA
1505 Holcombe Blvd.
Houston
TX
77030
USA
San Antonio
TX
78229
USA
Norfolk
VA
23502
USA
Atlanta
GA
30308
USA
Detroit
MI
48201
USA
3181 S.W. Sam Jackson Park Rd.
Portland
OR
97239
USA