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

Phase 1 Completed 30 enrolled Boehringer Ingelheim

Non-randomizedParallel-groupOpen-labelTreatment

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

Timeline

Start: 2012-05
Primary completion: 2014-11
Completion: 2015-01

Publications

Okusaka T, Otsuka T, Ueno H, Mitsunaga S, Sugimoto R, Muro K, Saito I, Tadayasu Y, Inoue K, Loembe AB, Ikeda M. Phase I study of nintedanib in Japanese patients with advanced hepatocellular carcinoma and liver impairment. Cancer Sci. 2016 Dec;107(12):1791-1799. doi: 10.1111/cas.13077. Epub 2016 Dec 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nintedanib	Small molecule	100 mg	Oral
Subject	Nintedanib	Small molecule	150 mg	Oral
Subject	Nintedanib	Small molecule	200 mg	Oral

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

Summary

Timeline

Publications

Drugs

Indications