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

NCT01594125 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2016-02-12

Study results available
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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

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

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2014-11-30
Completion
2015-01-31

Countries

  • Japan

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Entities

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 NCT01594125 on ClinicalTrials.gov