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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2015-01-31

Brief Summary

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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

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Detailed Description

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Conditions

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Carcinoma, Hepatocellular

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group I

patients with mild liver dysfunction according to their AST/ALT values and Child-Pugh score

Group Type EXPERIMENTAL

Nintedanib high dose

Intervention Type DRUG

twice daily oral dosing

Nintedanib medium dose

Intervention Type DRUG

twice daily oral dosing

Group II

patients with moderate liver dysfunction according to their AST/ALT values and Child-Pugh score

Group Type EXPERIMENTAL

Nintedanib low dose

Intervention Type DRUG

twice daily oral dosing

Nintedanib medium dose

Intervention Type DRUG

twice daily oral dosing

Nintedanib high dose

Intervention Type DRUG

twice daily oral dosing

Interventions

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Nintedanib high dose

twice daily oral dosing

Intervention Type DRUG

Nintedanib low dose

twice daily oral dosing

Intervention Type DRUG

Nintedanib medium dose

twice daily oral dosing

Intervention Type DRUG

Nintedanib medium dose

twice daily oral dosing

Intervention Type DRUG

Nintedanib high dose

twice daily oral dosing

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Histologically/cytologically confirmed hepatocellular carcinoma not amenable to curative surgery or loco-regional therapy
2. Age 20 years or older
3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1
4. Child-Pugh score of 7 or less
5. Life expectancy more than 3 months
6. Time interval from last loco-regional therapy more than 4 weeks
7. Written informed consent in accordance with good clinical practice (GCP)

Exclusion Criteria

1. More than one line of prior systemic therapy for metastatic/unresectable hepatocellular carcinoma (HCC)
2. Fibrolamellar HCC
3. Uncontrolled or refractory ascites
4. Inadequate organ function
5. Variceal bleeding within 6 months or the presence of inappropriate varices
6. History of major thrombotic (except portal vein thrombosis) or clinically relevant major bleeding event in the past 6 months
7. Major surgery within 4 weeks
8. Known inherited predisposition to bleeding or thrombosis
9. Significant cardiovascular diseases

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No