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

This study is currently recruiting participants.
Verified April 2014 by Boehringer Ingelheim
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01594125
First received: May 2, 2012
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention Phase
Carcinoma, Hepatocellular
Drug: Nintedanib high dose
Drug: Nintedanib low dose
Drug: Nintedanib medium dose
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Determination of maximum tolerated dose (MTD) of nintedanib [ Time Frame: up to 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Predose (trough) and maximum measured concentration in plasma at steady state [ Time Frame: up to 2 months ] [ Designated as safety issue: No ]
  • Amount of drug eliminated in urine at steady state [ Time Frame: up to 1 month ] [ Designated as safety issue: No ]
  • Incidence and intensity of adverse events according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 [ Time Frame: up to 28 months ] [ Designated as safety issue: No ]
  • Area under the concentration-time curve in plasma at steady state [ Time Frame: up to 1 month ] [ Designated as safety issue: No ]
  • Changes of safety laboratory values from baseline [ Time Frame: up to 28 months ] [ Designated as safety issue: No ]
  • Incidence of hepatitis B virus (HBV) reactivation [ Time Frame: up to 28 months ] [ Designated as safety issue: No ]
  • Objective tumour response according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 [ Time Frame: up to 28 months ] [ Designated as safety issue: No ]
  • Progression free survival (PFS) [ Time Frame: up to 28 months ] [ Designated as safety issue: No ]
  • Time to progression (TTP) [ Time Frame: up to 28 months ] [ Designated as safety issue: No ]
  • Response by alpha fetoprotein (AFP) [ Time Frame: up to 28 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 29
Study Start Date: May 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group I
patients with mild liver dysfunction according to their AST/ALT values and Child-Pugh score
Drug: Nintedanib high dose
twice daily oral dosing
Drug: Nintedanib medium dose
twice daily oral dosing
Experimental: Group II
patients with moderate liver dysfunction according to their AST/ALT values and Child-Pugh score
Drug: Nintedanib low dose
twice daily oral dosing
Drug: Nintedanib medium dose
twice daily oral dosing
Drug: Nintedanib high dose
twice daily oral dosing

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01594125

Contacts
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
Japan
1199.120.001 Boehringer Ingelheim Investigational Site Recruiting
Chuo-ku, Tokyo, Japan
1199.120.005 Boehringer Ingelheim Investigational Site Not yet recruiting
Fukuoka, Fukuoka, Japan
1199.120.002 Boehringer Ingelheim Investigational Site Recruiting
Kashiwa, Chiba, Japan
1199.120.003 Boehringer Ingelheim Investigational Site Recruiting
Nagoya, Aichi, Japan
1199.120.004 Boehringer Ingelheim Investigational Site Not yet recruiting
Saga, Saga, Japan
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01594125     History of Changes
Other Study ID Numbers: 1199.120
Study First Received: May 2, 2012
Last Updated: April 2, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on April 17, 2014