NCT01594125

Dose Escalation Study of Nintedanib (BIBF 1120) in Japanese Patients With Hepatocellular Carcinoma

An Open Label, Dose Escalation Phase I Study to Evaluate the Safety and Tolerability of Continuous Twice-daily Oral Treatment of Nintedanib in Japanese Patients With Hepatocellular Carcinoma.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to investigate the safety, tolerability, efficacy and pharmacokinetics (PK) for Japanese hepatocellular carcinoma which are not amenable to curative surgery or loco regional therapy

Conditions

• Carcinoma, Hepatocellular

Interventions

Type	Name	Description
DRUG	Nintedanib high dose	twice daily oral dosing
DRUG	Nintedanib low dose	twice daily oral dosing
DRUG	Nintedanib medium dose	twice daily oral dosing
DRUG	Nintedanib medium dose	twice daily oral dosing
DRUG	Nintedanib high dose	twice daily oral dosing

Timeline

• Start date: 2012-05-01
• Primary completion: 2014-11-01
• Completion: 2015-01-01
• First posted: 2012-05-08
• Last updated: 2016-02-12
• Results posted: 2015-12-22

Locations

5 sites across 1 country: Japan