Study Of AG-013736 (Axitinib) As Second-Line Treatment In Patients With Metastatic Renal Cell Cancer (mRCC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00569946
First received: December 7, 2007
Last updated: June 19, 2014
Last verified: June 2014
Results First Received: February 25, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Carcinoma, Renal Cell
Intervention: Drug: AG-013736

  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
No text entered.

Reporting Groups
  Description
AG-013736 The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.

Participant Flow:   Overall Study
    AG-013736  
STARTED     64  
COMPLETED     5  
NOT COMPLETED     59  
Adverse Event                 16  
Objective Progression or Relapse                 42  
Global Deterioration of Health Status                 1  



  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
AG-013736 The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.

Baseline Measures
    AG-013736  
Number of Participants  
[units: participants]
  64  
Age, Customized  
[units: participants]
 
<18     0  
18-44     6  
45-64     30  
>= 65     28  
Gender  
[units: participants]
 
Female     20  
Male     44  



  Outcome Measures
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1.  Primary:   Objective Response Rate (Percentage of Participants With Complete Response [CR] or Partial Response [PR]): Independent Review Committee Assessment   [ Time Frame: Up to 1709 days of treatment ]

2.  Primary:   Objective Response Rate (Percentage of Participants With Complete Response [CR] or Partial Response [PR]): Investigators Assessment   [ Time Frame: Up to 1709 days of treatment ]

3.  Secondary:   Progression-Free Survival (PFS)   [ Time Frame: Up to 1709 days of treatment ]

4.  Secondary:   Time to Tumor Progression (TTP)   [ Time Frame: Up to 1709 days of treatment ]

5.  Secondary:   Duration of Response   [ Time Frame: Start of first confirmed CR or PR to the date of the first event (PD or death) or the last tumor assessment ]

6.  Secondary:   Overall Survival (OS)   [ Time Frame: Up to 2002 days (maximum duration of treatment plus follow-up observation) ]

7.  Secondary:   Number of Participants Analyzed for Population Pharmacokinetics of AG-013736   [ Time Frame: Cycle 1 Day 1 (2 hours after morning dose); Cycles 3, 5, and 7 Day 1 predose and 2 hours post morning dose ]

8.  Secondary:   Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 1 (s-VEGFR1)   [ Time Frame: Cycle 1 Day 1 predose, Day 1 of Cycle 2 to Cycle 7, and end of treatment/discontinuation ]

9.  Secondary:   Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 2 (s-VEGFR2)   [ Time Frame: Cycle 1 Day 1 predose, Day 1 of Cycle 2 to Cycle 7, and end of treatment/discontinuation ]

10.  Secondary:   Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 3 (s-VEGFR3)   [ Time Frame: Cycle 1 Day 1 predose, Day 1 of Cycle 2 to Cycle 7, and end of treatment/discontinuation ]

11.  Secondary:   Plasma Concentration of Soluble Stem Cell Factor Receptor (s-KIT)   [ Time Frame: Cycle 1 Day 1 predose, Day 1 of Cycle 2 to Cycle 7, and end of treatment/discontinuation ]

12.  Secondary:   Plasma Concentration of Vascular Endothelial Growth Factor (VEGF)   [ Time Frame: Cycle 1 Day 1 predose, Day 1 of Cycle 2 to Cycle 7, and end of treatment/discontinuation ]

13.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: Up to 1709 days of treatment plus 28-days follow-up ]


  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: NCT00569946     History of Changes
Other Study ID Numbers: A4061035
Study First Received: December 7, 2007
Results First Received: February 25, 2012
Last Updated: June 19, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare