Ignite Creation Date:
2024-05-05 @ 11:55 PM
Last Modification Date:
2024-10-26 @ 10:41 AM
Study NCT ID:
NCT01440959
Status:
COMPLETED
Last Update Posted:
2020-01-18
First Post:
2011-09-08
Brief Title:
Dovitinib for ImatinibSumitinib-failed Gastrointestinal Stromal Tumors GIST TKI258
Sponsor:
Asan Medical Center
Organization:
Asan Medical Center
Study Overview
Official Title:
A Phase II Trial of TKI258 in Patients With Metastatic or Advanced Gastrointestinal Stromal Tumors GIST After Failure to Imatinib and SunitinibCTKI258AKR01T
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
With discovery of KIT mutations and the advent of KIT tyrosine kinase inhibitor imatinib GlivecTM Novartis there has been substantial improvement in overall survival in patients with advanced andor metastatic gastrointestinal tumors GIST Recently sunitinib SuteneTM Pfizer showed activity as second-line therapy in GIST patients after failure with imatinib However virtually all patients will eventually progress or become intolerable after the first-line imatinib and the second-line sunitinib Dovitinib TKI258 Novartis is a multi-kinase inhibitor TKI258 is a potent inhibitor of the VEGFR 1 2 and 3 FGFR1 2 and 3 PDGFRβ Kit RET TrkA CSF 1R and FLT3 with inhibitory concentration 50 IC50s of less than 40nM Stem cell factor SCF also termed KIT ligand or steel factor has been shown to modulate tumor angiogenesis In cultured human endothelial cells and Kit expressing cancer cells TKI258 inhibits VEGF- and SCF-stimulated mitogenesis
Detailed Description:
It is well known that KIT and PDGFR which can be inhibited by TKI258 have a crucial role in the development and proliferation of GIST and in general FGFR has an important role in angiogenesis and tumor proliferation in many cancers We assume that TKI258 can be also effective in patients with GIST The objective of this study is to evaluate the safety and activity of TKI258 given as salvage treatment for GIST after failure to standard imatinib and sunitinib
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None