Conditions: Carcinoma, Hepatocellular
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 125
Healthy volunteers: no

Brief 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

Detailed description:

Arms:
arm 1: Phase I dose escalation and phase II using dose determined in phase I ( 200 mg BID) arm 2: None

Interventions: intervention 1: Sorafenib intervention 2: BIBF 1120
Intervention descriptions: intervention 1: None intervention 2: Dose escalated in phase I until MTD or adjusted by investigator, dose in phase II part based on phase I data

Protocol document: