TRIAL DETAIL

Efficacy and Safety of AMN107 in Patients With GastroIntestinal Stromal Tumors (GIST) Who Have Failed Both Imatinib and Sunitinib

Drug:
Trial Name:
Efficacy and Safety of AMN107 in Patients With GastroIntestinal Stromal Tumors (GIST) Who Have Failed Both Imatinib and Sunitinib
NCT#:
Conditions:
Gastrointestinal Stromal Tumor
Status:
Completed
Phase:
2
Start Date 09/01/2008
Age of Trial (yrs) 16.7
Treatment Phase:
Gleevec-resistant
Drug Category:
KIT/PDGFRA inhibitor
Strategy:
Block KIT
Trial Type:
Specifically GIST and only GIST
Other Protocol IDs:
CAMN107D1201
Sponsor:
Novartis
Patient Contact:
Novartis Japan 81 3 3797 8748 Novartis US 862-778-8330
Contact email:
Contact Phone:
Randomized:
IV or Oral:
Oral
Trial Notes:
AMN107 is manufactured by Novartis. AMN107 is a newer and possibly more potent tyrosine kinase inhibitor. Like Gleevec, it also inhibits KIT, PDGFRA, and BCR/ABL. Phase III trials began in the U.S. in late April of 2007 and as of 4/7/08 have reached accrual goals. This is a phase 2 trial open at 8 sites in Japan.

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
Sapporo
Hokkaido
060-8648
Japan
Niigata
Japan
Chiba
277-8577
Japan
Tokyo
Japan
Kyushu
Japan
Aichi
464-8681
Japan
Osaka
Japan
Shizuoka
411-8777
Japan