Study Of Sunitinib Malate Versus Sorafenib In Patients With Inoperable Liver Cancer

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00699374
First received: June 16, 2008
Last updated: December 7, 2012
Last verified: December 2012
Results First Received: December 7, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Carcinoma, Hepatocellular
Interventions: Drug: sunitinib malate
Drug: sorafenib

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One participant was randomized twice, once to the sorafenib arm and discontinued prior to receiving treatment and a second randomization to the sunitinib arm and dispensed treatment.

Reporting Groups
  Description
Sunitinib Participants received sunitinib 37.5 milligram (mg) capsules by mouth once daily on a continuous daily dosing schedule. Dose reductions to either 25 mg or 12.5 mg were allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
Sorafenib Participants received sorafenib 400 mg tablets by mouth, twice daily (BID). Dose reduction to 400 mg once daily (QD) was allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.

Participant Flow:   Overall Study
    Sunitinib     Sorafenib  
STARTED     530     544  
Treated     526     542  
COMPLETED     0     0  
NOT COMPLETED     530     544  
Death                 93                 83  
Adverse Event                 70                 67  
Global deterioration of health status                 7                 8  
Lost to Follow-up                 3                 5  
Withdrawal by Subject                 34                 44  
Objective progression or relapse                 281                 277  
Unspecified                 18                 15  
Protocol Violation                 2                 6  
Study terminated by sponsor                 13                 28  
Randomized but not treated                 4                 2  
Died 28 days after last dose                 5                 9  



  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.
No text entered.

Reporting Groups
  Description
Sunitinib Participants received sunitinib 37.5 milligram (mg) capsules by mouth once daily on a continuous daily dosing schedule. Dose reductions to either 25 mg or 12.5 mg were allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
Sorafenib Participants received sorafenib 400 mg tablets by mouth, twice daily (BID). Dose reduction to 400 mg once daily (QD) was allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
Total Total of all reporting groups

Baseline Measures
    Sunitinib     Sorafenib     Total  
Number of Participants  
[units: participants]
  530     544     1074  
Age  
[units: Years]
Mean ± Standard Deviation
  58.1  ± 12.86     58.5  ± 12.93     58.3  ± 12.89  
Gender  
[units: Participants]
     
Female     94     85     179  
Male     436     459     895  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Survival (OS)   [ Time Frame: Baseline, every 4 weeks during treatment, every 8 weeks posttreatment up to Week 150 ]

2.  Secondary:   Progression-Free Survival (PFS)   [ Time Frame: Baseline, every 4 weeks during treatment, every 8 weeks posttreatment up to Week 150 ]

3.  Secondary:   Time to Tumor Progression (TTP)   [ Time Frame: Baseline, every 4 weeks during treatment, every 8 weeks posttreatment up to Week 150 ]

4.  Secondary:   European Quality of Life (EQ-5D)- Health State Profile Utility Score   [ Time Frame: Day 1 of each cycle ]


  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
Study terminated early due to futility. Subsequently, EQ-5D data were not collected or analyzed.


  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: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided by Pfizer

Publications automatically indexed to this study:

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00699374     History of Changes
Other Study ID Numbers: A6181170
Study First Received: June 16, 2008
Results First Received: December 7, 2012
Last Updated: December 7, 2012
Health Authority: United States: Food and Drug Administration