Clinical trial NCT01594125: Dose Escalation Study of Nintedanib (BIBF 1120) in Japanese Patients With Hepatocellular Carcinoma
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Carcinoma, Hepatocellular
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2012-05-08
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Dose Limiting Toxicities to Determine Maximum Tolerated Dose (MTD) of Nintedanib
timeFrame: up to 28 days
Secondary outcomes:
measure: Number of Participants With Objective Tumour Response According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.0
timeFrame: up to 28 months
measure: Progression Free Survival (PFS)
timeFrame: up to 28 months
measure: Time to Progression (TTP)
timeFrame: up to 28 months
measure: Number of Participants With Response by Alpha Fetoprotein (AFP)
timeFrame: up to 28 months
Other outcomes:
Locations:
city: Chuo-ku, Tokyo
country: Japan
facility: 1199.120.001 Boehringer Ingelheim Investigational Site
city: Fukuoka, Fukuoka
country: Japan
facility: 1199.120.005 Boehringer Ingelheim Investigational Site
city: Kashiwa, Chiba
country: Japan
facility: 1199.120.002 Boehringer Ingelheim Investigational Site
city: Nagoya, Aichi
country: Japan
facility: 1199.120.003 Boehringer Ingelheim Investigational Site
city: Saga, Saga
country: Japan
facility: 1199.120.004 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Okusaka 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.