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Study of the Anti-angiogenesis Agent AG-013736 in Patients With Metastatic Thyroid Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00094055
First received: October 8, 2004
Last updated: June 21, 2012
Last verified: June 2012
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: Thyroid Neoplasms
Intervention: Drug: AG013736

  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     60  
COMPLETED     0  
NOT COMPLETED     60  
Adverse Event                 11  
Death                 4  
Lack of Efficacy                 17  
Lost to Follow-up                 2  
progressive disease                 2  
clinical progression                 1  
roll-over to another study                 14  
Withdrawal by Subject                 9  



  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]
  60  
Age  
[units: years]
Mean ± Standard Deviation
  59.3  ± 13.7  
Gender  
[units: participants]
 
Female     25  
Male     35  



  Outcome Measures
  Show All Outcome Measures

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 206 weeks ]

2.  Secondary:   Progression-Free Survival (PFS)   [ Time Frame: Baseline to disease progression or death due to any cause, assessed every 8 weeks up to 206 weeks ]

3.  Secondary:   Duration of Response (DR)   [ Time Frame: Baseline to disease progression or discontinuation from study due to any cause, assessed every 8 weeks up to 206 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 206 weeks ]

6.  Other Pre-specified:   Plasma Concentrations of Soluble Proteins   [ Time Frame: Day 1 (pre-dose) and then every 8 weeks up to 206 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 (AG-013736) 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


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00094055     History of Changes
Other Study ID Numbers: A4061014
Study First Received: October 8, 2004
Results First Received: February 25, 2012
Last Updated: June 21, 2012
Health Authority: United States: Food and Drug Administration