Clinical trial · Interventional
Dose Escalation Study of Nintedanib (BIBF 1120) in Japanese Patients With Hepatocellular Carcinoma
An Open Label, Dose Escalation Phase I Study to Evaluate the Safety and Tolerability of Continuous Twice-daily Oral Treatment of Nintedanib in Japanese Patients With Hepatocellular Carcinoma.
NCT01594125CI-TRIAL-00020897completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Hepatocellular | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nintedanib high dose | Drug | Nintedanib | ALIAS |
| Nintedanib low dose | Drug | Nintedanib | ALIAS |
| Nintedanib medium dose | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group I
- description
- patients with mild liver dysfunction according to their AST/ALT values and Child-Pugh score
- interventionNames
- Drug: Nintedanib high dose
- Drug: Nintedanib medium dose
- type
- EXPERIMENTAL
- label
- Group II
- description
- patients with moderate liver dysfunction according to their AST/ALT values and Child-Pugh score
- interventionNames
- Drug: Nintedanib low dose
- Drug: Nintedanib medium dose
- Drug: Nintedanib high dose
Primary outcomes (1)
- measure
- Number of Participants With Dose Limiting Toxicities to Determine Maximum Tolerated Dose (MTD) of Nintedanib
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDOkusaka T, Otsuka T, Ueno H, Mitsunaga S, Sugimoto R, Muro K, Saito I, Tadayasu Y, Inoue K, Loembe AB, Ikeda M. Phase I study of nintedanib in Japanese patients with advanced hepatocellular carcinoma and liver impairment. Cancer Sci. 2016 Dec;107(12):1791-1799. doi: 10.1111/cas.13077. Epub 2016 Dec 12. PMID 27627050