Axitinib (AG-013736) For the Treatment of Metastatic Renal Cell Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00920816
First received: June 11, 2009
Last updated: September 9, 2014
Last verified: September 2014
Results First Received: July 26, 2013  
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
First-line participants included all treatment-naive participants with metastatic renal cell cancer (mRCC) from global and second-line participants included all previously-treated Asian participants with mRCC.

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 (First-line Participants) Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 milligram (mg) orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
Sorafenib (First-line Participants) Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
Axitinib (Second-line Participants) Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
Sorafenib (Second-line Participants) Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.

Participant Flow:   Overall Study
    Axitinib (First-line Participants)     Sorafenib (First-line Participants)     Axitinib (Second-line Participants)     Sorafenib (Second-line Participants)  
STARTED     192     96     135     69  
Treated     189     96     135     69  
COMPLETED     0     0     0     0  
NOT COMPLETED     192     96     135     69  
Death                 77                 36                 58                 28  
Adverse Event                 1                 0                 1                 0  
Lost to Follow-up                 1                 2                 3                 4  
Objective progression or relapse                 0                 0                 2                 0  
Withdrawal by Subject                 7                 2                 1                 1  
Ongoing                 106                 56                 70                 36  



  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
Axitinib (First-line Participants) Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
Sorafenib (First-line Participants) Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
Axitinib (Second-line Participants) Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
Sorafenib (Second-line Participants) Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
Total Total of all reporting groups

Baseline Measures
    Axitinib (First-line Participants)     Sorafenib (First-line Participants)     Axitinib (Second-line Participants)     Sorafenib (Second-line Participants)     Total  
Number of Participants  
[units: participants]
  192     96     135     69     492  
Age, Customized  
[units: participants]
         
Less than (<) 65 years     142     77     110     56     385  
Greater than or equal to (>=) 65 years     50     19     25     13     107  
Gender  
[units: participants]
         
Female     58     22     41     20     141  
Male     134     74     94     49     351  



  Outcome Measures
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1.  Primary:   Progression Free Survival (PFS): First-Line Participants   [ Time Frame: Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107) ]

2.  Primary:   Progression Free Survival (PFS): Second-Line Participants   [ Time Frame: Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103) ]

3.  Secondary:   Percentage of Participants With Objective Response (OR): First-Line Participants   [ Time Frame: Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107) ]

4.  Secondary:   Percentage of Participants With Objective Response (OR): Second-Line Participants   [ Time Frame: Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103) ]

5.  Secondary:   Duration of Response (DR): First-Line Participants   [ Time Frame: Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107) ]

6.  Secondary:   Duration of Response (DR): Second-Line Participants   [ Time Frame: Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103) ]

7.  Secondary:   Overall Survival (OS): First-Line Participants   [ Time Frame: Baseline until death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107) ]

8.  Secondary:   Overall Survival (OS): Second-Line Participants   [ Time Frame: Baseline until death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103) ]

9.  Other Pre-specified:   Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants   [ Time Frame: Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose) ]

10.  Other Pre-specified:   Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants   [ Time Frame: Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose) ]

11.  Other Pre-specified:   Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants   [ Time Frame: Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose) ]

12.  Other Pre-specified:   Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants   [ Time Frame: Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose) ]

13.  Other Pre-specified:   Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants   [ Time Frame: Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose) ]

14.  Other Pre-specified:   Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants   [ Time Frame: Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose) ]

15.  Other Pre-specified:   Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants   [ Time Frame: Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose) ]

16.  Other Pre-specified:   Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants   [ Time Frame: Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose) ]


  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
The objective of the statistical analysis for secondary endpoints was to summarize data using descriptive statistics without performing any hypothesis testing.


  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: NCT00920816     History of Changes
Other Study ID Numbers: A4061051
Study First Received: June 11, 2009
Results First Received: July 26, 2013
Last Updated: September 9, 2014
Health Authority: United States: Food and Drug Administration