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

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Carcinoma, Hepatocellular

Treatments: Drug: BIBF 1120; Drug: Sorafenib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00987935

1199.39

Details and patient eligibility

About

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

Enrollment: 134 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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134 participants in 2 patient groups

Nintedanib (BIBF 1120)

Experimental group

Description:

Phase I dose escalation and phase II using dose determined in phase I

Treatment:

Drug: BIBF 1120

Sorafenib

Active Comparator group

Description:

Twice daily dosing in phase II

Treatment:

Drug: Sorafenib