Anti-angiogenesis Agent AG-013736 in Patients With Advanced Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00094094
First received: October 11, 2004
Last updated: June 21, 2012
Last verified: June 2012
Results First Received: February 25, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Lung Neoplasms
Carcinoma, Non-small Cell Lung
Intervention: Drug: axitinib

  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 or the participant withdrew consent.

Participant Flow:   Overall Study
    Axitinib  
STARTED     32  
COMPLETED     0  
NOT COMPLETED     32  
Death                 2  
Lack of Efficacy                 23  
Adverse Event                 7  



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

Baseline Measures
    Axitinib  
Number of Participants  
[units: participants]
  32  
Age  
[units: Years]
Mean ± Standard Deviation
  64.1  ± 12.3  
Gender  
[units: Participants]
 
Female     13  
Male     19  



  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 98 weeks ]

2.  Secondary:   Progression-Free Survival (PFS)   [ Time Frame: Baseline until the date of first documented progression or death due to any cause, assessed every 8 weeks up to 98 weeks ]

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 98 weeks ]

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 ]

5.  Other Pre-specified:   Population Pharmacokinetics for Axitinib (AG-013736) Plasma Concentrations   [ Time Frame: Day 1 (pre-dose), Day 29, Day 57 and then every 8 weeks up to 98 weeks ]

6.  Other Pre-specified:   Plasma Concentrations of Soluble Proteins   [ Time Frame: Day 1 (pre-dose) and then every 8 weeks up to 98 weeks ]


  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
Population pharmacokinetics and plasma concentrations of soluble proteins were not presented, as the data was not available for the single study and data for all the axitinib Phase 2 studies would be pooled together in a separate report.


  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


ClinicalTrials.gov Identifier: NCT00094094     History of Changes
Other Study ID Numbers: A4061011
Study First Received: October 11, 2004
Results First Received: February 25, 2012
Last Updated: June 21, 2012
Health Authority: United States: Food and Drug Administration