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Anti-angiogenesis Agent AG-013736 in Patients With Metastatic Renal Cell Carcinoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00076011
First received: January 12, 2004
Last updated: June 20, 2012
Last verified: June 2012
History of Changes
Results First Received: February 25, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Kidney Neoplasms
Intervention: Drug: Vascular Endothelial Growth Factor Receptor [VEGFR] and Platelet-Derived Growth Factor Receptor [PDGFR] inhibitor

  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
Axitinib Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.

Participant Flow:   Overall Study
    Axitinib  
STARTED     52  
COMPLETED     0  
NOT COMPLETED     52  
Death                 1  
Adverse Event                 10  
Lack of Efficacy                 25  
Withdrawal by Subject                 1  
Study terminated by sponsor                 3  
Unspecified                 11  
Ongoing                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Axitinib Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.

Baseline Measures
    Axitinib  
Number of Participants  
[units: participants]
 		  52  
Age  
[units: Years]
Mean ± Standard Deviation 		  58.8  ± 11.25  
Gender  
[units: Participants]
 		 
Female     12  
Male     40  



  Outcome Measures
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1.  Primary:   Percentage of Participants With Objective Response (OR)   [ Time Frame: Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 139 weeks ]
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Measure Type Primary
Measure Title Percentage of Participants With Objective Response (OR)
Measure Description Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Time Frame Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 139 weeks  
Safety Issue No  

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.
Study Population included all participants who received at least 1 dose of study medication and had a baseline assessment of disease.

Reporting Groups
  Description
Axitinib Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.

Measured Values
    Axitinib  
Number of Participants Analyzed  
[units: participants]
 		  52  
Percentage of Participants With Objective Response (OR)  
[units: Percentage of participants]
Number ( 95% Confidence Interval ) 		  44.2  
  ( 30.5 to 58.7 )  

No statistical analysis provided for Percentage of Participants With Objective Response (OR)



2.  Secondary:   Time to Disease Progression (TTP)   [ Time Frame: Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 139 weeks ]
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3.  Secondary:   Duration of Response (DR)   [ Time Frame: Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 139 weeks ]
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4.  Secondary:   Overall Survival (OS)   [ Time Frame: Baseline to death due to any cause or at least 1 year after the initial dose for the last treated participant ]
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5.  Secondary:   Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score   [ Time Frame: Baseline, Days 29, 57, 113, 169, 225, 281, 337, 393, 449, 505, 561, 617, 673, 729, 785, 841, 897, 953 and follow-up visit after last dose ]
  Show Outcome Measure 5

6.  Other Pre-specified:   Population Pharmacokinetics of Axitinib (AG-013736)   [ Time Frame: Day 1 (Pre-dose), Day 29, Day 57 and then every 8 weeks up to 139 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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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.


Limitations and Caveats
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
No text entered.  


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: NCT00076011     History of Changes
Obsolete Identifiers: NCT00077272
Other Study ID Numbers: A4061012
Study First Received: January 12, 2004
Results First Received: February 25, 2012
Last Updated: June 20, 2012
Health Authority: United States: Food and Drug Administration