At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 134 enrolled
Drug / intervention
Sorafenib +1 moredrug
Likely dose
BIBF 1120 twice daily or Sorafenib 400 mg twice dailyAI-extracted
Key inclusion· 4
- ✓Hepatocellular carcinoma (histologically/cytologically confirmed or clinically diagnosed) not amenable to curative surgery or loco-regional therapy
- ✓Age 18 years or older
- ✓ECOG performance status 0-2
- ✓Child-Pugh score ≤7
Key exclusion· 9
- ✕Prior systemic therapy for metastatic/unresectable HCC (Phase II only)
- ✕More than one line of prior systemic therapy for metastatic/unresectable HCC (Phase I)
- ✕Uncontrolled or refractory ascites despite adequate medical therapy
- ✕Bilirubin >1.5 × ULN
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Open Label, Phase I/Randomized II Study to Evaluate Safety, Pharmacokinetics and Efficacy of BIBF 1120 in Comparison With Sorafenib for Advanced Hepatocellular Carcinoma Patients in Asia.
In Brief
A Phase 2 clinical trial evaluating Sorafenib and BIBF 1120 for Carcinoma, Hepatocellular. Completed, enrolled 134 participants across 16 sites in 2 countries.
Detailed Summary
This study is to evaluate the safety, appropriate dose, and efficacy of BIBF 1120 in liver cancer patients
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Hepatocellular
CountriesSouth Korea, Taiwan
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 2009
Enrollment StartOct 2009
Primary CompletionJul 2014
Study CompletionJan 2016
TodayJul 2026
First PostedOct 1, 2009
Enrollment StartOct 1, 2009
Primary CompletionJul 1, 2014
Study CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 16.8 years ago
Interventions
Sorafenibdrug
400 mg twice daily
BIBF 1120drug
Twice daily