TRIAL DETAIL

Efficacy and Safety of AMN107 Compared With Current Treatment Options in Patients With GIST Who Have Failed Both Imatinib and Sunitinib (ENEST)

Drug:
Trial Name:
Efficacy and Safety of AMN107 Compared With Current Treatment Options in Patients With GIST Who Have Failed Both Imatinib and Sunitinib (ENEST)
NCT#:
Conditions:
Gastrointestinal Stromal Tumor
Status:
Completed
Phase:
3
Start Date 03/01/2007
Age of Trial (yrs) 14.8
Treatment Phase:
Gleevec-resistant
Drug Category:
KIT/PDGFRA inhibitor
Strategy:
Block KIT
Trial Type:
Specifically GIST and only GIST
Other Protocol IDs:
CAMN107A2201 (ENEST)
Sponsor:
Novartis
Patient Contact:
Novartis
Contact email:
Contact Phone:
800-340-6843
Randomized:
Randomized
IV or Oral:
Oral
Trial Notes:
AMN107 is manufactured by Novartis. Like Gleevec, Also also inhibits KIT, PDGFRA, and BCR/ABL. Phase III trials began in late April of 2007 and as of 4/7/08 have reached accrual goals.
The phase III trial is for patients that are resistant (or intolerant) to both Gleevec and Sutent. Patients were randomized to receive either AMN107 or best supportive care. For every patient that received best supportive care, two patients received AMN107. Best supportive care allows the treating physician to continue administering Gleevec, Sutent, or other supporting care. Patients receiving best supportive care will be allowed to cross over to receive AMN107 at the time of progression. Patients receiving AMN107 will be given 400 mg twice a day (800 mg total).

Trial Links

 
 
 
 

Trial Results

 
 
 
 

Drug Information

Nilotinib prescribing information
 
Tasigna.com
 
Tasigna medication guide
 
FDA approves Tasigna for CML
 
Nilotinib (Tasigna) in Wikipedia
 
Nilotinib scientific discussion (pdf)
 
Nilotinib Compassionate Use In Advanced GIST- A Retrospective Analysis (Poster PDF)
 
Tasigna International Patient Assistance Program (TIPAP)
 
Nilotinib for patients with advanced GIST who failed imatinib and sunitinib: Negative effect of prior major gastrectomy on exposure to nilotinib -ASCO 2010
 
Effects of rifampin and ketoconazole on the pharmacokinetics of nilotinib in healthy participants
 
Novartis discontinues clinical trial of Tasigna® for investigational use in newly diagnosed patients with unresectable and/or metastatic GIST
 
Clinical experience to date with nilotinib in gastrointestinal stromal tumors (Pubmed)
 
Pharmacokinetics and pharmacodynamics of nilotinib in gastrointestinal stromal tumors (Pubmed)
 
Progressive peripheral arterial occlusive disease and other vascular events during nilotinib therapy in CML
 
Extended kinase profile and properties of the protein kinase inhibitor nilotinib
 
Severe adverse events associated with the use of second-line BCR/ABL tyrosine kinase inhibitors: preferential occurrence in patients with comorbidities
 
Calcium carbonate does not affect nilotinib pharmacokinetics in healthy volunteers.
 
Nilotinib exacerbates diabetes mellitus by decreasing secretion of endogenous insulin
 
Early onset hypercholesterolemia induced by the second generation tyrosine kinase inhibitor nilotinib in patients with chronic phase-chronic myeloid leukemia
 
Application of systematic coronary risk evaluation chart to identify chronic myeloid leukemia patients at risk of cardiovascular diseases during nilotinib treatment.
 
Association between severe toxicity of nilotinib and UGT1A1 polymorphisms in Japanese patients with chronic myelogenous leukemia.
 
Hyperhomocysteinemia and high doses of nilotinib favor cardiovascular events in chronic phase Chronic Myelogenous Leukemia patients
 
Nilotinib-induced vasculopathy: identification of vascular endothelial cells as a primary target site
 
Genetic predisposition and induced pro-inflammatory/pro-oxidative status may play a role in increased atherothrombotic events in nilotinib treated chronic myeloid leukemia patients
 

Trial Sites

Name
Address
City
State
Zip
Country
450 Brookline Ave
Boston
MA
02215-5450
USA
333 Cottman Ave
Philadelphia
PA
19111
USA
660 S. Euclid Ave
St. Louis
MO
63110
USA
4100 John R
Detroit
MI
48201
USA
12902 Magnolia Dr.
Tampa
FL
33612
USA
Medical Center Boulevard
Winston-Salem
NC
27157
USA
5841 S. Maryland Ave
Chicago
IL
60637
USA
110 Irving St
Washington
DC
20010
USA
10945 Le Conte Ave.
Los Angeles
CA
90095
USA
1505 Holcombe Blvd.
Houston
TX
77030
USA
550 First Avenue
New York
NY
10016
USA
Berlin
Germany
Essen
Germany
Munchen
Germany
Hannover
Germany
Frankfurt
Germany
Koln
Germany
Dusseldorf
Germany
Tubingen
Germany
Mannheim
68135
Germany