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Phase I/II Comparison of Efficacy and Safety of BIBF 1120 and Sorafenib in Patients With Advanced Hepatocellular Carcinoma

NCT01004003 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2017-10-26

Study results available
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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

  • Carcinoma, Hepatocellular

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-22
Primary Completion
2014-07-14
Completion
2016-10-12

Countries

  • Austria
  • France
  • Germany
  • Hungary
  • Netherlands
  • Poland
  • Romania
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01004003 on ClinicalTrials.gov