TRIAL DETAIL

Treatment of Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumors in First Line With Nilotinib. (OPEN)

Drug:
Trial Name:
Treatment of Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumors in First Line With Nilotinib. (OPEN)
NCT#:
Conditions:
Gastrointestinal Stromal Tumor
Status:
Active, not recruiting
Phase:
2
Start Date 08/29/2008
Age of Trial (yrs) 16.6
Treatment Phase:
First-line
Drug Category:
KIT/PDGFRA inhibitor
Strategy:
Block KIT
Trial Type:
Specifically GIST and only GIST
Other Protocol IDs:
CAMN107DDE06, EUDRACT- Nr. 2008-000358-11
Sponsor:
Novartis
Patient Contact:
Novartis Basel + 41 61 324 1111 +1-800-340-6843
Contact email:
Contact Phone:
Randomized:
IV or Oral:
Oral
Trial Notes:
This phase II trial looks at how effective nilotinib (AMN107) would be if given initially for GIST instead of Gleevec. The trial is only for patients with metastatic or unresectable GIST that have never had Gleevec.
Nilotinib is also in phase III trials for third-line therapy in GIST after failure of Gleevec and Sutent.
Nilotinib is a potent inhibitor of KIT as well as Bcr-abl and PDGFR.

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
Bad Saarow
Germany
Milan
20132
Italy
Helsinki
Finland
Lyon
69373
France
Munchen
Germany
Barcelona
08036
Spain
Mallorca
Spain
Valencia
46009
Spain