TRIAL DETAIL

Dovitinib for Imatinib/Sunitinib-failed Gastrointestinal Stromal Tumors (GIST)

Drug:
Trial Name:
Dovitinib for Imatinib/Sunitinib-failed Gastrointestinal Stromal Tumors (GIST)
NCT#:
Conditions:
Gastrointestinal Stromal Tumor
Status:
Completed
Phase:
2
Start Date 09/01/2011
Age of Trial (yrs) 10.2
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:
CTKI258AKR01T
Sponsor:
Asan Medical Center
Patient Contact:
Yoon-Koo Kang, Md, PhD +82-2-3010-3230 ykkang@amc.seoul.kr Min-Hee Ryu, MD, PhD +82-2-3010-5935 miniryu@amc.seoul.kr
Contact email:
Contact Phone:
Randomized:
IV or Oral:
Oral
Trial Notes:
Background:

This prospective, phase II trial evaluated the efficacy and safety of dovitinib in patients with metastatic and/or unresectable gastrointestinal stromal tumours (GISTs) after failure of at least imatinib and sunitinib.

Methods:

Patients received oral dovitinib, 500 mg once daily, for 5 consecutive days, followed by a 2-day rest, every 28 days. The primary endpoint was disease control rate (DCR; objective response+stable disease (SD)) at 24 weeks, assessed by computed tomography (CT) scan according to RECIST v1.0. Metabolic response was evaluated by positron emission tomography (PET)–CT scans performed at baseline and after 4 weeks of treatment.

Trial results are available, see Trial Results link.

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
Seoul
Songpa-gu
138-736
Republic of Korea