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Completed

NCT Number: NCT01594125

Dose Escalation Study of Nintedanib (BIBF 1120) in Japanese Patients With Hepatocellular Carcinoma

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

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Key information

Conditions

Carcinoma, Hepatocellular Adenocarcinoma Carcinoma Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

1199.120.001 Boehringer Ingelheim Investigational Site, Chuo-ku, Tokyo, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nintedanib high dose

Drug

twice daily oral dosing

Nintedanib low dose

Drug

twice daily oral dosing

Nintedanib medium dose

Drug

twice daily oral dosing

Primary outcomes

  1. Number of Participants With Dose Limiting Toxicities to Determine Maximum Tolerated Dose (MTD) of Nintedanib

    Time frame: up to 28 days

    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.

Secondary outcomes

  1. Number of Participants With Objective Tumour Response According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.0

    Time frame: up to 28 months

    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.

  2. Progression Free Survival (PFS)

    Time frame: up to 28 months

    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.

  3. Time to Progression (TTP)

    Time frame: up to 28 months

    TTP is defined as the duration from the start date of the study treatment to PD according to RECIST 1.0.

  4. Number of Participants With Response by Alpha Fetoprotein (AFP)

    Time frame: up to 28 months

    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.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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.

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
May 8, 2012
Registry last updated
Feb 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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