Sorafenib Dose Ramp-Up in Hepatocellular Carcinoma (HCC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01203787
First received: September 10, 2010
Last updated: February 13, 2015
Last verified: February 2015
Results First Received: January 27, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hepatocellular Carcinoma
Interventions: Drug: Sorafenib Standard Dosing Regimen
Drug: Sorafenib Ramp-Up Regimen

  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
Sorafenib Standard Dosing Regimen Sorafenib 400 mg (2 tablets of 200 mg) twice daily until end of treatment or week 24
Sorafenib Ramp-Up Regimen 200 mg daily from Day 0-Day 13 200 mg twice daily from Day 14-Day 20 600 mg daily from Day 21-Day 27 400 mg twice daily beginning Day 28 until end of treatment or Week 24

Participant Flow:   Overall Study
    Sorafenib Standard Dosing Regimen     Sorafenib Ramp-Up Regimen  
STARTED     63     57  
COMPLETED     32     30  
NOT COMPLETED     31     27  
Death                 12                 10  
Withdrawal by Subject                 6                 2  
Lost to Follow-up                 2                 0  
Adverse Event                 11                 15  



  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
Sorafenib Standard Dosing Regimen Sorafenib 400 mg (2 tablets of 200 mg) twice daily until end of treatment or week 24
Sorafenib Ramp-Up Regimen 200 mg daily from Day 0-Day 13, 200 mg twice daily from Day 14-Day 20, 600 mg daily from Day 21-Day 27, 400 mg twice daily beginning Day 28 until end of treatment or Week 24
Total Total of all reporting groups

Baseline Measures
    Sorafenib Standard Dosing Regimen     Sorafenib Ramp-Up Regimen     Total  
Number of Participants  
[units: participants]
  63     57     120  
Age  
[units: participants]
     
<=18 years     00     00     0  
Between 18 and 65 years     39     30     69  
>=65 years     24     27     51  
Age  
[units: years]
Mean (Standard Deviation)
  62.0  (6.8)     63.5  (7.5)     62.7  (7.2)  
Gender  
[units: participants]
     
Female     12     10     22  
Male     51     47     98  
Region of Enrollment  
[units: participants]
     
United States     63     57     120  



  Outcome Measures
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1.  Primary:   Total (Cumulative) Dose Delivery of Sorafenib   [ Time Frame: 4 months-1/12/2010-1/27/14 ]

2.  Primary:   Cumulative Dose of Sorafenib   [ Time Frame: 11/22/2010-1/27/14 ]

3.  Secondary:   Safety and Efficacy of Sorafenib Dosing Regimens   [ Time Frame: Baseline-End of Treatment (11/22/2010-3/10/2014) ]

4.  Secondary:   Safety of Dosing Regimens as Assessed by the Frequency and Severity of Adverse Events According to National Cancer Institute- CTCAE   [ Time Frame: 11/22/2010-3/10/2014 ]

5.  Secondary:   Frequency and Severity of Adverse Events According to National Cancer Institute- CTCAE   [ Time Frame: 11/22/2010-3/10/2014 ]

6.  Secondary:   Number of Subjects With Dose Interruptions   [ Time Frame: Baseline-End of Treatment (11/22/2010-3/10/2014) ]

7.  Secondary:   Number of Subjects With Dose Reductions   [ Time Frame: 11/22/2010-3/10/2014 ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: Roniel Cabrera, MD
Organization: UNIVERSITY OF FLORIDA
phone: 352-273-9468
e-mail: RONIEL.CABRERA@MEDICINE.UFL.EDU


No publications provided


Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01203787     History of Changes
Other Study ID Numbers: ONC-2010-19
Study First Received: September 10, 2010
Results First Received: January 27, 2015
Last Updated: February 13, 2015
Health Authority: United States: Food and Drug Administration