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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Carcinoma, Hepatocellular

Treatments: Drug: Nintedanib medium dose; Drug: Nintedanib low dose; Drug: Nintedanib high dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT01594125

1199.120

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Group I

Experimental group

Description:

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

Treatment:

Drug: Nintedanib medium dose

Drug: Nintedanib high dose

Drug: Nintedanib high dose

Drug: Nintedanib medium dose

Group II

Experimental group

Description:

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

Treatment:

Drug: Nintedanib medium dose

Drug: Nintedanib high dose

Drug: Nintedanib high dose

Drug: Nintedanib medium dose

Drug: Nintedanib low dose