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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
twice daily oral dosing
twice daily oral dosing
twice daily oral dosing
1199.120.001 Boehringer Ingelheim Investigational Site
Chuo-ku, Tokyo, Japan
1199.120.005 Boehringer Ingelheim Investigational Site
Fukuoka, Fukuoka, Japan
1199.120.002 Boehringer Ingelheim Investigational Site
Kashiwa, Chiba, Japan
1199.120.003 Boehringer Ingelheim Investigational Site
Nagoya, Aichi, Japan
Number of Participants With Dose Limiting Toxicities to Determine Maximum Tolerated Dose (MTD) of Nintedanib
The MTD is based on the incidence of Dose Limiting Toxicities (DLTs). A drug-related AE was considered as a DLT if one of the following met: CTCAE grade 4 thrombocytopenia of any duration, CTCAE grade 4 neutropenia lasting for ≥8 days, CTCAE grade 4 febrile neutropenia of any duration, CTCAE grade 3 or 4 non-haematologic toxicity (with the following exception: Alopecia, Vomiting, nausea, or diarrhoea with no adequate supportive care, Transient electrolyte abnormality, which resolves spontaneously or can be corrected with appropriate treatment within 3 days, Liver toxicity), Liver enzyme toxicity of AST, ALT, alkaline phosphatase \[ALP\] elevation \>5x ULN, or total bilirubin \>3x ULN if baseline liver enzymes are within the normal range, or AST, ALT or ALP \> baseline value + 4x ULN if the baseline value is elevated. The MTD was determined to be 200mg bid.
Time frame: up to 28 days
Number of Participants With Objective Tumour Response According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.0
Objective response (Complete response (CR) + Partial response (PR), regardless of confirmation) is derived from a patient's best objective response by RECIST. Best objective response is calculated based on the "overall" visit response from each assessment. Best objective response represents the best response a patient has had during their time in the study up until progression, last evaluable assessment in the absence of progression or the start of subsequent anti-cancer therapy. For patients whose progression event is death, best objective response will be calculated based on data up until the last evaluable RECIST assessment prior to death.
Time frame: up to 28 months
Progression Free Survival (PFS)
PFS is defined as the duration from start date of the study treatment to PD according to RECIST 1.0, or any death whichever occurs earlier.
Time frame: up to 28 months
Time to Progression (TTP)
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twice daily oral dosing
twice daily oral dosing
1199.120.004 Boehringer Ingelheim Investigational Site
Saga, Saga, Japan
TTP is defined as the duration from the start date of the study treatment to PD according to RECIST 1.0.
Time frame: up to 28 months
Number of Participants With Response by Alpha Fetoprotein (AFP)
Response by AFP is defined as 20% or more decline in AFP between the baseline value and the AFP value after three courses (12 weeks) of therapy. If patients only receive two courses of therapy the AFP value after two courses (8 weeks) will be used for the analysis.
Time frame: up to 28 months