TRIAL DETAIL

Efficacy and Safety of Dovitinib in Patients With Gastrointestinal Stromal Tumors Refractory and/or Intolerant to Imatinib (DoviGIST)

Drug:
Trial Name:
Efficacy and Safety of Dovitinib in Patients With Gastrointestinal Stromal Tumors Refractory and/or Intolerant to Imatinib (DoviGIST)
NCT#:
Conditions:
Gastrointestinal Stromal Tumor
Status:
Completed
Phase:
2
Start Date 01/15/2012
Age of Trial (yrs) 12.3
Treatment Phase:
Gleevec-resistant
Drug Category:
KIT/PDGFRA inhibitor+ VEGF inhibitor (TKI)
Strategy:
Block KIT + Block blood vessel growth
Trial Type:
Specifically GIST and only GIST
Other Protocol IDs:
CTKI258AIC02, 2011-001725-24
Sponsor:
Novartis
Patient Contact:
Contact: Novartis Pharmaceuticals 862-778-8300
Contact email:
Contact Phone:
Randomized:
IV or Oral:
Oral
Trial Notes:
This phase II trial will look at the effectiveness of dovitinib (TKI258) in treating GIST patients that are resistant to imatinib (Glivec). Patients can not have had Sutent or any other targeted treatment except imatinib (second line trial).
Dovitinib is a KIT/PDGFRA/VEGFR that also inhibits additional kinases. Dovitinib is made by Novartis.

Trial Links

Trial Results

Drug Information
Phase 1 PK & PD study of TKI258 in solid tumors (full text article)
 
Novartis info on TKI258 Dovitinib
 
Phase II study of dovitinib in patients with metastatic and/or unresectable gastrointestinal stromal tumours after failure of imatinib and sunitinib
 
Analysis of serum protein biomarkers, circulating tumor DNA, and dovitinib activity in patients with tyrosine kinase inhibitor-refractory gastrointestinal stromal tumors.
 

Trial Sites

Name
Address
City
State
Zip
Country
Reims
France
Milan
20132
Italy
Barcelona
08035
Spain
Bordeaux
33076
France
Lille Cedex
59020
France
Lyon
69373
France