At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 125 enrolled
Drug / intervention
Sorafenib +1 moredrug
Likely dose
Not stated in 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.
A Multicenter, Open Label, Phase I /Randomised Phase II Study to Evaluate Safety, Pharmacokinetics and Efficacy of BIBF 1120 in Comparison With Oral Sorafenib for Advanced Hepatocellular Carcinoma Patients.
In Brief
A Phase 2 clinical trial evaluating Sorafenib and BIBF 1120 for Carcinoma, Hepatocellular. Completed, enrolled 125 participants across 28 sites in 8 countries.
Detailed Summary
The study aim is to determine maximally tolerated dose (MTD) of BIBF 1120 in HCC (hepatocellular cancer) and compare efficacy of BIBF 1120 to Sorafenib in HCC patients
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Hepatocellular
CountriesAustria, France, Germany, Hungary, Netherlands, Poland, Romania, United Kingdom
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2009
First PostedOct 2009
Primary CompletionJul 2014
Study CompletionOct 2016
TodayJul 2026
First PostedOct 29, 2009
Enrollment StartOct 22, 2009
Primary CompletionJul 14, 2014
Study CompletionOct 12, 2016
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 16.7 years ago
Interventions
Sorafenibdrug
BIBF 1120drug
Dose escalated in phase I until MTD or adjusted by investigator, dose in phase II part based on phase I data