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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01594125
First received: May 2, 2012
Last updated: January 11, 2016
Last verified: January 2016
Results First Received: November 17, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Carcinoma, Hepatocellular
Interventions: Drug: Nintedanib high dose
Drug: Nintedanib low dose
Drug: Nintedanib medium dose

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Group I: Nintedanib 150mg Bid Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 150mg twice daily
Group I: Nintedanib 200mg Bid Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 200mg twice daily
Group II: Nintedanib 100mg Bid Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 100mg twice daily
Group II: Nintedanib 150mg Bid Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 x to <=5 upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 150mg twice daily
Group II: Nintedanib 200mg Bid Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 200mg twice daily

Participant Flow:   Overall Study
    Group I: Nintedanib 150mg Bid     Group I: Nintedanib 200mg Bid     Group II: Nintedanib 100mg Bid     Group II: Nintedanib 150mg Bid     Group II: Nintedanib 200mg Bid  
STARTED     4     12     3     4     7  
COMPLETED     0     0     0     0     0  
NOT COMPLETED     4     12     3     4     7  
Withdrawal by Subject                 1                 0                 0                 1                 0  
Progressive Disease                 3                 12                 3                 3                 7  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Group I: Nintedanib 150mg Bid Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 150mg twice daily
Group I: Nintedanib 200mg Bid Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 200mg twice daily
Group II: Nintedanib 100mg Bid Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 100mg twice daily
Group II: Nintedanib 150mg Bid Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 x to <=5 upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 150mg twice daily
Group II: Nintedanib 200mg Bid Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 200mg twice daily
Total Total of all reporting groups

Baseline Measures
    Group I: Nintedanib 150mg Bid     Group I: Nintedanib 200mg Bid     Group II: Nintedanib 100mg Bid     Group II: Nintedanib 150mg Bid     Group II: Nintedanib 200mg Bid     Total  
Number of Participants  
[units: participants]
  4     12     3     4     7     30  
Age  
[units: years]
Mean (Standard Deviation)
  67.0  (14.72)     63.1  (9.84)     73.3  (2.31)     66.5  (6.56)     67.4  (4.35)     66.1  (8.81)  
Gender  
[units: participants]
           
Female     2     1     3     2     1     9  
Male     2     11     0     2     6     21  



  Outcome Measures
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1.  Primary:   Number of Participants With Dose Limiting Toxicities to Determine Maximum Tolerated Dose (MTD) of Nintedanib   [ Time Frame: up to 28 days ]

2.  Secondary:   Number of Participants With Objective Tumour Response According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.0   [ Time Frame: up to 28 months ]

3.  Secondary:   Progression Free Survival (PFS)   [ Time Frame: up to 28 months ]

4.  Secondary:   Time to Progression (TTP)   [ Time Frame: up to 28 months ]

5.  Secondary:   Number of Participants With Response by Alpha Fetoprotein (AFP)   [ Time Frame: up to 28 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Boehringer Ingelheim, Call Center
Organization: Boehringer Ingelheim
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com



Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01594125     History of Changes
Other Study ID Numbers: 1199.120
Study First Received: May 2, 2012
Results First Received: November 17, 2015
Last Updated: January 11, 2016
Health Authority: Japan: Ministry of Health, Labor and Welfare