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A Study to Estimate Safety and Efficacy of Sorafenib (BAY43-9006) in the Treatment of Hepatocellular Carcinoma

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00044512
First received: August 30, 2002
Last updated: March 7, 2013
Last verified: March 2013
History of Changes
Results First Received: February 20, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Carcinoma, Hepatocellular
Intervention: Drug: Sorafenib (Nexavar, BAY43-9006)

  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
Only subjects with measurable, histologically or cytologically documented hepatocellur carcinoma (HCC) which was inoperable or who had refused surgery could participate in this study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 147 enrolled patients, 137 received treatment. 10 patients failed screening; reasons were: target lesions identified at baseline (3), liver function tests too high for inclusion (2), prior systemic anticancer treatment (2), creatinine too high for inclusion (1), platelets too low for inclusion (1), diagnosis of HCC not confirmed (1)

Reporting Groups
  Description
Sorafenib 400 mg b.i.d. Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)

Participant Flow for 2 periods

 Period 1:   Treatment
    Sorafenib 400 mg b.i.d.  
STARTED     137  
COMPLETED     137  
NOT COMPLETED     0  

Period 2:   Follow Up
    Sorafenib 400 mg b.i.d.  
STARTED     137  
COMPLETED     135  
NOT COMPLETED     2  
Lost to Follow-up                 2  



  Baseline Characteristics
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Reporting Groups
  Description
Sorafenib 400 mg b.i.d. Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)

Baseline Measures
    Sorafenib 400 mg b.i.d.  
Number of Participants  
[units: participants]
 		  137  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     84  
>=65 years     53  
Gender  
[units: participants]
 		 
Female     40  
Male     97  
Child Pugh Status [1]
[units: participants]
 		 
Status A     98  
Status B     38  
Missing     1  
Eastern Cooperative Group performance status (ECOG PS) at study entry [2]
[units: participants]
 		 
Grade 0     68  
Grade 1     69  
Grade 2     0  
Grade 3     0  
Grade 4     0  
Stage of Disease at study entry (TNM Classification) [3]
[units: participants]
 		 
Stage 1     0  
Stage 2     4  
Stage 3     42  
Stage 4     91  
[1] A Child-Pugh (CP) score (determined by encephalopathy grade, ascites, serum bilirubin and albumin, prothrombin time) is used to assess the prognosis of chronic liver disease, mainly cirrhosis. One of the inclusion criterion for this study was a CP class A (good operative risk) or B (moderate risk) score; class C (poor operative risk) was excluded.
[2] Eastern Cooperative Oncology Group (ECOG) Performance Status is a scale that measures how cancer affects a patient. 0 = fully active, 1 = restricted strenuous activity, 2 = ambulatory, 3 = limited selfcare, 4 = completely disabled, 5 = dead. Subjects entering this study must have had an ECOG score of 0 or 1.
[3] TNM (Tumor, Nodes, Metastasis) is a solid tumor classification system. T1-T4 = size and degree of spreading. N0-N3 = degree of spreading into lymph nodes. M0-M1 = whether the cancer has metastazied beyond the lymph nodes or not. Bigger numbers are worse. One of the inclusion criteria for this study was inoperable tumor T2-T4, any N, M0 or M1.



  Outcome Measures
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1.  Primary:   Percentage of Participants for Each Type of Response   [ Time Frame: Until 30 days after termination of active therapy ]
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2.  Secondary:   Duration of Response   [ Time Frame: up to 3 years later ]
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3.  Secondary:   Time to Response   [ Time Frame: up to 3 years later ]
  Show Outcome Measure 3

4.  Secondary:   Time to Progression   [ Time Frame: up to 3 years later ]
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5.  Secondary:   Duration of Stable Disease   [ Time Frame: up to 3 years later ]
  Show Outcome Measure 5

6.  Secondary:   Time to Minor Response   [ Time Frame: up to 3 years later ]
  Show Outcome Measure 6

7.  Secondary:   Duration of Minor Response   [ Time Frame: Time from MR to PD ]
  Show Outcome Measure 7

8.  Secondary:   Overall Survival   [ Time Frame: Start of treatment to death ]
  Show Outcome Measure 8


  Serious Adverse Events
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  Other Adverse Events
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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.


Limitations and Caveats
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
Subjects had advanced disease and were heavily pretreated. National Cancer Institute-Common Toxicity Criteria (NCI-CTC) was translated to Medical Dictionary for Regulatory Activities (MedDRA) for System Organ Class (SOC) only.  


Results Point of Contact:  
Name/Title: Therapeutic Area Head
Organization: BAYER
e-mail: clinical-trials-contact@bayerhealthcare.com


Publications of Results:


Responsible Party: Therapeutic Area Head, Bayer HealtCare Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00044512     History of Changes
Obsolete Identifiers: NCT00048919, NCT00058383
Other Study ID Numbers: 10874
Study First Received: August 30, 2002
Results First Received: February 20, 2009
Last Updated: March 7, 2013
Health Authority: United States: Food and Drug Administration