Axitinib (AG 013736) As Second Line Therapy For Metastatic Renal Cell Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00678392
First received: May 12, 2008
Last updated: June 25, 2014
Last verified: June 2014
Results First Received: February 25, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Kidney Neoplasms
Interventions: Drug: Axitinib (AG-013736)
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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Axitinib Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily (BID) in cycles of 4 weeks.
Sorafenib Sorafenib 400 mg tablet administered orally BID in cycles of 4 weeks.

Participant Flow:   Overall Study
    Axitinib     Sorafenib  
STARTED     361     362  
Treated     359     355  
COMPLETED     0     0  
NOT COMPLETED     361     362  
Adverse Event                 1                 0  
Death                 103                 102  
Withdrawal by Subject                 2                 4  
Protocol Violation                 2                 0  
Lost to Follow-up                 3                 4  
Objective progression or relapse                 3                 6  
Global deterioration of health status                 1                 0  
Unspecified                 2                 3  
Randomized but not treated                 2                 7  
Ongoing                 242                 236  



  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
Axitinib Axitinib (AG-013736) 5 mg tablet administered orally BID in cycles of 4 weeks.
Sorafenib Sorafenib 400 mg tablet administered orally BID in cycles of 4 weeks.
Total Total of all reporting groups

Baseline Measures
    Axitinib     Sorafenib     Total  
Number of Participants  
[units: participants]
  361     362     723  
Age, Customized  
[units: Participants]
     
Less than 65 years     238     238     476  
Greater than or equal to 65 years     123     124     247  
Gender  
[units: Participants]
     
Female     96     104     200  
Male     265     258     523  



  Outcome Measures

1.  Primary:   Progression-Free Survival (PFS)   [ Time Frame: Week 6, Week 12, every 8 weeks thereafter up to 3 years ]

2.  Secondary:   Overall Survival (OS)   [ Time Frame: Week 6, Week 12, every 8 weeks thereafter up to 3 years ]
Results not yet posted.   Anticipated Posting Date:   07/2014   Safety Issue:   No

3.  Secondary:   Percentage of Participants With Objective Response (OR)   [ Time Frame: Week 6, Week 12, every 8 weeks thereafter up to 3 years ]
Results not yet posted.   Anticipated Posting Date:   07/2014   Safety Issue:   No

4.  Secondary:   Duration of Response (DR)   [ Time Frame: Week 6, Week 12, every 8 weeks thereafter up to 3 years ]
Results not yet posted.   Anticipated Posting Date:   07/2014   Safety Issue:   No

5.  Secondary:   Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15) Score   [ Time Frame: Baseline, Day 1 of every cycle until disease progression and Day 28 of follow-up visit (up to 670 days) ]
Results not yet posted.   Anticipated Posting Date:   07/2014   Safety Issue:   No

6.  Secondary:   FKSI-Disease Related Symptoms (FKSI-DRS) Score   [ Time Frame: Baseline, Day 1 of every cycle until disease progression and Day 28 of follow-up visit (up to 670 days) ]
Results not yet posted.   Anticipated Posting Date:   07/2014   Safety Issue:   No

7.  Secondary:   Euro Quality of Life Questionnaires- 5 Dimension (EQ-5D) Index Score   [ Time Frame: Baseline, Day 1 of every cycle until disease progression and Day 28 of follow-up visit (up to 670 days) ]
Results not yet posted.   Anticipated Posting Date:   07/2014   Safety Issue:   No

8.  Secondary:   EQ-5D Visual Analog Scale (EQ-5D VAS)   [ Time Frame: Baseline, Day 1 of every cycle until disease progression and Day 28 of follow-up visit (up to 670 days) ]
Results not yet posted.   Anticipated Posting Date:   07/2014   Safety Issue:   No


  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: 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: NCT00678392     History of Changes
Other Study ID Numbers: A4061032, AXIS TRIAL
Study First Received: May 12, 2008
Results First Received: February 25, 2012
Last Updated: June 25, 2014
Health Authority: United States: Food and Drug Administration