Status:
COMPLETED
A Phase I / II Trial of Nintedanib in Asian Hepatocellular Carcinoma Patients
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Carcinoma, Hepatocellular
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study is to evaluate the safety, appropriate dose, and efficacy of BIBF 1120 in liver cancer patients
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Hepatocellular carcinoma, either histologically/cytologically confirmed or clinically diagnosed, which is not amenable to curative surgery or loco-regional therapy
- Age 18 years or older
- Eastern Cooperative Group performance score of 2 or less
- Child-Pugh score of 7 or less
- Written informed consent in accordance with International Conference on Harmonisation (ICH) and Good Clinical Practice (GCP) and local legislation
- Exclusion criteria:
- Prior systemic therapy for metastatic/unresectable hepatocellular carcinoma (for phase II)
- More than one line of prior systemic therapy for metastatic/unresectable hepatocellular carcinoma (for phase I)
- Uncontrolled or refractory ascites to adequate medical therapy
- Bilirubin greater than 1.5 times upper limit of normal
- Aspartate amino transferase or alanine amino transferase greater than 5 times upper limit of normal
- Absolute neutrophil count less than 1500/microliter
- Platelet count less than 75000/microliter
- Hemoglobin less than 9 g/dL
- Serum creatinine greater than 1.5 times upper limit of normal
Exclusion
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT00987935
Start Date
October 1 2009
End Date
January 1 2016
Last Update
March 10 2016
Active Locations (16)
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1
1199.39.82001 Boehringer Ingelheim Investigational Site
Seoul, South Korea
2
1199.39.82002 Boehringer Ingelheim Investigational Site
Seoul, South Korea
3
1199.39.82003 Boehringer Ingelheim Investigational Site
Seoul, South Korea
4
1199.39.82004 Boehringer Ingelheim Investigational Site
Seoul, South Korea