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

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

Gastrointestinal Stromal Tumor

Completed

2

Start Date 09/01/2011

Age of Trial (yrs) 13.2

Gleevec-resistant

KIT/PDGFRA inhibitor+ VEGF inhibitor (TKI)

Block KIT + Block blood vessel growth

Specifically GIST and only GIST

CTKI258AKR01T

Asan Medical Center

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

Oral

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.