A Study In Patients With Advanced Solid Tumor

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00726752
First received: July 30, 2008
Last updated: May 17, 2012
Last verified: May 2012
Results First Received: February 25, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Neoplasms
Intervention: Drug: Axitinib (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 Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.

Participant Flow:   Overall Study
    AG-013736  
STARTED     6  
COMPLETED     0  
NOT COMPLETED     6  
Lack of Efficacy                 6  



  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.
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Reporting Groups
  Description
AG-013736 Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.

Baseline Measures
    AG-013736  
Number of Participants  
[units: participants]
  6  
Age  
[units: years]
Mean ± Standard Deviation
  53.8  ± 15.8  
Gender  
[units: participants]
 
Female     3  
Male     3  



  Outcome Measures
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1.  Primary:   Single Dose: Maximum Observed Plasma Concentration (Cmax)   [ Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose ]

2.  Primary:   Area Under the Plasma Concentration-Time Curve From Time Zero to Time Infinity (AUCinf)   [ Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose ]

3.  Primary:   Single Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax)   [ Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose ]

4.  Primary:   Single Dose: Plasma Decay Half-Life (t1/2)   [ Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose ]

5.  Secondary:   Multiple Dose: Maximum Observed Plasma Concentration (Cmax)   [ Time Frame: Cycle 1 Day 15 predose in the morning, and 0.5, 1, 2, 4, 8 and 12 hour postdose ]

6.  Secondary:   Multiple Dose: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)   [ Time Frame: Cycle 1 Day 15 predose in the morning, and 0.5, 1, 2, 4, 8 and 12 hour postdose ]

7.  Secondary:   Multiple Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax)   [ Time Frame: Cycle 1 Day 15 predose in the morning, and 0.5, 1, 2, 4, 8 and 12 hour postdose ]

8.  Secondary:   Multiple Dose: Accumulation Ratio for Cmax (Rac Cmax) and Accumulation Ratio for AUCtau (Rac AUCtau)   [ Time Frame: Cycle 1 Day 15 predose in the morning, and 0.5, 1, 2, 4, 8 and 12 hour postdose ]

9.  Secondary:   Percent Change From Baseline in Soluble Vascular Endothelial Growth Factor Receptor 1, 2, and 3 (s-VEGFR1, s-VEGFR2 and s-VEGFR3), Vascular Endothelial Growth Factor (VEGF), Soluble Stem Cell Factor Receptor (s-KIT )   [ Time Frame: Prior to the initial dose (baseline) and Day 1 of Cycle 2 ]

10.  Secondary:   Number of Participants With Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progression of Disease (PD) According to the Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0)   [ Time Frame: Up to 470 days ]

11.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: Up to 470 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


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00726752     History of Changes
Other Study ID Numbers: A4061044
Study First Received: July 30, 2008
Results First Received: February 25, 2012
Last Updated: May 17, 2012
Health Authority: United States: Food and Drug Administration