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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Boehringer Ingelheim
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01594125
First received: May 2, 2012
Last updated: July 9, 2014
Last verified: July 2014

May 2, 2012
July 9, 2014
May 2012
October 2014   (final data collection date for primary outcome measure)
Determination of maximum tolerated dose (MTD) of nintedanib [ Time Frame: up to 28 days ] [ Designated as safety issue: No ]
Determination of maximum tolerated dose (MTD) of nintedanib [ Time Frame: up to 1 month ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01594125 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Predose (trough) and maximum measured concentration in plasma at steady state [ Time Frame: up to 2 months ] [ Designated as safety issue: No ]
  • Terminal rate constant in plasma at steady state [ Time Frame: up to 1 month ] [ Designated as safety issue: No ]
  • Time from last dosing to the maximum concentration in plasma at steady state [ Time Frame: up to 1 month ] [ Designated as safety issue: No ]
  • Mean residence time in the body at steady state after administration [ Time Frame: up to 1 month ] [ Designated as safety issue: No ]
  • Apparent clearance in plasma at steady state [ Time Frame: up to 1 month ] [ Designated as safety issue: No ]
  • Apparent volume of distribution during the terminal phase at steady state [ Time Frame: up to 1 month ] [ 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 ]
  • Terminal half-life in plasma 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 12 months ] [ Designated as safety issue: Yes ]
  • 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 12 months ] [ Designated as safety issue: Yes ]
  • Incidence of hepatitis B virus (HBV) reactivation [ Time Frame: up to 12 months ] [ Designated as safety issue: Yes ]
  • Objective tumour response according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
  • Progression free survival (PFS) [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
  • Time to progression (TTP) [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
  • Response by alpha fetoprotein (AFP) [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Dose Escalation Study of Nintedanib (BIBF 1120) in Japanese Patients With Hepatocellular Carcinoma
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.

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

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Carcinoma, Hepatocellular
  • Drug: Nintedanib high dose
    twice daily oral dosing
  • Drug: Nintedanib low dose
    twice daily oral dosing
  • Drug: Nintedanib medium dose
    twice daily oral dosing
  • Experimental: Group I
    patients with mild liver dysfunction according to their AST/ALT values and Child-Pugh score
    Interventions:
    • Drug: Nintedanib high dose
    • Drug: Nintedanib medium dose
  • Experimental: Group II
    patients with moderate liver dysfunction according to their AST/ALT values and Child-Pugh score
    Interventions:
    • Drug: Nintedanib low dose
    • Drug: Nintedanib medium dose
    • Drug: Nintedanib high dose
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
August 2015
October 2014   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com
Japan
 
NCT01594125
1199.120
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP