Overview

A Phase I / II Trial of Nintedanib in Asian Hepatocellular Carcinoma Patients

Status:
Completed

Trial end date:
2016-01-01

Target enrollment:
0

Participant gender:
All

Summary

This study is to evaluate the safety, appropriate dose, and efficacy of BIBF 1120 in liver cancer patients

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Boehringer Ingelheim

Treatments:

Nintedanib
Sorafenib

Criteria

Inclusion criteria:

1. Hepatocellular carcinoma, either histologically/cytologically confirmed or clinically
diagnosed, which is not amenable to curative surgery or loco-regional therapy

2. Age 18 years or older

3. Eastern Cooperative Group performance score of 2 or less

4. Child-Pugh score of 7 or less

5. Written informed consent in accordance with International Conference on Harmonisation
(ICH) and Good Clinical Practice (GCP) and local legislation

Exclusion criteria:

1. Prior systemic therapy for metastatic/unresectable hepatocellular carcinoma (for phase
II)

2. More than one line of prior systemic therapy for metastatic/unresectable
hepatocellular carcinoma (for phase I)

3. Uncontrolled or refractory ascites to adequate medical therapy

4. Bilirubin greater than 1.5 times upper limit of normal

5. Aspartate amino transferase or alanine amino transferase greater than 5 times upper
limit of normal

6. Absolute neutrophil count less than 1500/microliter

7. Platelet count less than 75000/microliter

8. Hemoglobin less than 9 g/dL

9. Serum creatinine greater than 1.5 times upper limit of normal