Phase 1
Completed N=30
Dose Escalation Study of Nintedanib (BIBF 1120) in Japanese Patients With Hepatocellular Carcinoma
Carcinoma, Hepatocellular
Source: ClinicalTrials.gov NCT01594125 ↗
Enrolled (actual)
30
Serious AEs
33.3%
Results posted
Dec 2015
Primary outcomePrimary: Number of Participants With Dose Limiting Toxicities to Determine Maximum Tolerated Dose (MTD) of Nintedanib — 0; 0; 0; 0 participants
Summary
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Dose Limiting Toxicities to Determine Maximum Tolerated Dose (MTD) of Nintedanib |
0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Objective Tumour Response According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 |
0; 0; 0; 0; 0 | — |
| SECONDARY Progression Free Survival (PFS) |
6.05; 2.76; 7.26; 2.40; 2.76 | — |
| SECONDARY Time to Progression (TTP) |
6.05; 2.76; 7.26; 2.40; 2.76 | — |
| SECONDARY Number of Participants With Response by Alpha Fetoprotein (AFP) |
2; 1; 1; 1; 1 | — |
Eligibility Criteria
Inclusion criteria
- Histologically/cytologically confirmed hepatocellular carcinoma not amenable to curative surgery or loco-regional therapy
- Age 20 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1
- Child-Pugh score of 7 or less
- Life expectancy more than 3 months
- Time interval from last loco-regional therapy more than 4 weeks
- Written informed consent in accordance with good clinical practice (GCP)
Exclusion criteria
- More than one line of prior systemic therapy for metastatic/unresectable hepatocellular carcinoma (HCC)
- Fibrolamellar HCC
- Uncontrolled or refractory ascites
- Inadequate organ function
- Variceal bleeding within 6 months or the presence of inappropriate varices
- History of major thrombotic (except portal vein thrombosis) or clinically relevant major bleeding event in the past 6 months
- Major surgery within 4 weeks
- Known inherited predisposition to bleeding or thrombosis
- Significant cardiovascular diseases
Data sourced from ClinicalTrials.gov (NCT01594125). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.