At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 162 enrolled
Drug / intervention
dovitinib +1 moredrug
Likely dose
dovitinib 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label, Randomized, Multi-center, Phase II Study to Compare the Safety and Efficacy of TKI258 Versus Sorafenib as First-line Treatment in Adult Patients With Advanced Hepatocellular Carcinoma
In Brief
A Phase 2 clinical trial evaluating dovitinib and sorafenib for Hepatocellular Carcinoma. Completed, enrolled 162 participants across 24 sites in 7 countries.
Detailed Summary
The purpose of this open-label, randomized, phase II study is to compare the safety and efficacy of dovitinib versus sorafenib as first-line treatment in adult patients with advanced Hepatocellular Carcinoma (HCC). This trial will be opened in countries of the Asia-Pacific region.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatocellular Carcinoma
CountriesChina, Hong Kong, Japan, Singapore, South Korea, Taiwan, Thailand
Collaborators--
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 2010
Enrollment StartJul 2011
Primary CompletionApr 2014
TodayJul 2026
First PostedNov 2, 2010
Enrollment StartJul 1, 2011
Primary CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 15.7 years ago
Interventions
dovitinibdrug
500 mg p.o. o.d. 5 days on/2 days off
sorafenibdrug
400 mg p.o. b.i.d.