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

NCT ID: NCT00987935

Last Updated: 2016-03-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2016-01-31

Brief Summary

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

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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

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nintedanib (BIBF 1120)

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

Group Type EXPERIMENTAL

BIBF 1120

Intervention Type DRUG

Twice daily

Sorafenib

Twice daily dosing in phase II

Group Type ACTIVE_COMPARATOR

Sorafenib

Intervention Type DRUG

400 mg twice daily

Interventions

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Sorafenib

400 mg twice daily

Intervention Type DRUG

BIBF 1120

Twice daily

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1199.39.82001 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1199.39.82002 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1199.39.82003 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1199.39.82004 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1199.39.82005 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1199.39.82006 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1199.39.88606 Boehringer Ingelheim Investigational Site

Changhua, , Taiwan

Site Status

1199.39.88609 Boehringer Ingelheim Investigational Site

Kaohsiung City, , Taiwan

Site Status

1199.39.88610 Boehringer Ingelheim Investigational Site

Kaohsiung City, , Taiwan

Site Status

1199.39.88605 Boehringer Ingelheim Investigational Site

Taichung, , Taiwan

Site Status

1199.39.88602 Boehringer Ingelheim Investigational Site

Tainan City, , Taiwan

Site Status

1199.39.88608 Boehringer Ingelheim Investigational Site

Tainan City, , Taiwan

Site Status

1199.39.88601 Boehringer Ingelheim Investigational Site

Taipei, , Taiwan

Site Status

1199.39.88603 Boehringer Ingelheim Investigational Site

Taipei, , Taiwan

Site Status

1199.39.88604 Boehringer Ingelheim Investigational Site

Taoyuan, , Taiwan

Site Status

1199.39.88607 Boehringer Ingelheim Investigational Site

Yunlin County, , Taiwan

Site Status

Countries

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South Korea Taiwan

Other Identifiers

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1199.39

Identifier Type: -

Identifier Source: org_study_id

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