Trials / Completed
CompletedNCT01004003
Phase I/II Comparison of Efficacy and Safety of BIBF 1120 and Sorafenib in Patients With Advanced Hepatocellular Carcinoma
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.
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 125 (actual)
- Sponsor
- Boehringer Ingelheim · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sorafenib | |
| DRUG | BIBF 1120 | Dose escalated in phase I until MTD or adjusted by investigator, dose in phase II part based on phase I data |
Timeline
- Start date
- 2009-10-22
- Primary completion
- 2014-07-14
- Completion
- 2016-10-12
- First posted
- 2009-10-29
- Last updated
- 2017-10-26
- Results posted
- 2015-08-07
Locations
28 sites across 8 countries: Austria, France, Germany, Hungary, Netherlands, Poland, Romania, United Kingdom
Source: ClinicalTrials.gov record NCT01004003. Inclusion in this directory is not an endorsement.