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Study Of AG-013736 (Axitinib) In Patients With Advanced Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00447005
First received: March 12, 2007
Last updated: May 17, 2012
Last verified: May 2012
History of Changes
Results First Received: February 25, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Carcinoma
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
Six participants initially received a single dose of AG-013736 5 mg followed by 5 mg twice daily (BID) multiple dosing. They were monitored for dose limiting toxicity (DLT) up to multiple dosing Cycle 1. Since no more than 1 of the first 6 participants had a DLT, 6 additional participants initiated AG-013736 from multiple dosing per the protocol.

Reporting Groups
  Description
AG-013736

Single dose (first 6 participants only): Single AG-013736 5 mg was administered orally.

Multiple dose (all participants): AG-013736 5 mg twice daily (BID) was administered orally in fed state, 12 hours apart at approximately the same time each day. AG-013736 dose was titrated or reduced based on the dose modification criteria: the available dose was 2, 3, 5, 7, or 10 mg at a time. One cycle length was 28 days and participants continued the study treatment until intolerable toxicity or disease progression occurred.

Participant Flow:   Overall Study
    AG-013736  
STARTED     12  
COMPLETED     0  
NOT COMPLETED     12  
Adverse Event                 1  
Lack of Efficacy                 11  



  Baseline Characteristics
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Reporting Groups
  Description
AG-013736

Single dose (first 6 participants only): Single AG-013736 5 mg was administered orally.

Multiple dose (all participants): AG-013736 5 mg twice daily (BID) was administered orally in fed state, 12 hours apart at approximately the same time each day. AG-013736 dose was titrated or reduced based on the dose modification criteria: the available dose was 2, 3, 5, 7, or 10 mg at a time. One cycle length was 28 days and participants continued the study treatment until intolerable toxicity or disease progression occurred.

Baseline Measures
    AG-013736  
Number of Participants  
[units: participants]
 		  12  
Age  
[units: years]
Mean ± Standard Deviation 		  60.2  ± 13.1  
Gender  
[units: participants]
 		 
Female     5  
Male     7  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Adverse Events   [ Time Frame: Up to 795 days of treatment plus 28-days follow-up ]
  Show Outcome Measure 1

2.  Secondary:   Maximum Observed Plasma Concentration (Cmax): Single Dose   [ Time Frame: Single dose: predose, 0.5, 1, 2, 4, 6, 8, 12, 24, and 32 hours postdose ]
  Show Outcome Measure 2

3.  Secondary:   Time to Reach Maximum Observed Plasma Concentration (Tmax): Single Dose   [ Time Frame: Single dose: predose, 0.5, 1, 2, 4, 6, 8, 12, 24, and 32 hours postdose ]
  Show Outcome Measure 3

4.  Secondary:   Area Under The Plasma Concentration-Time Curve From Time Zero to Time Infinity (AUCinf): Single Dose   [ Time Frame: Single dose: predose, 0.5, 1, 2, 4, 6, 8, 12, 24, and 32 hours postdose ]
  Show Outcome Measure 4

5.  Secondary:   Terminal Phase Plasma Half-Life (t1/2): Single Dose   [ Time Frame: Single dose: predose, 0.5, 1, 2, 4, 6, 8, 12, 24, and 32 hours postdose ]
  Show Outcome Measure 5

6.  Secondary:   Maximum Observed Plasma Concentration (Cmax): Multiple Dose   [ Time Frame: Multiple dose Cycle 1 Day 1 and 15: predose, 0.5, 1, 2, 4, 8 and 12 hours postdose ]
  Show Outcome Measure 6

7.  Secondary:   Time to Reach Maximum Observed Plasma Concentration (Tmax): Multiple Dose   [ Time Frame: Multiple dose Cycle 1 Day 1 and 15: predose, 0.5, 1, 2, 4, 8 and 12 hours postdose ]
  Show Outcome Measure 7

8.  Secondary:   Area Under The Plasma Concentration-Time Curve Over Dosing Interval Tau (AUCtau): Multiple Dose   [ Time Frame: Multiple dose Cycle 1 Day 1 and 15: predose, 0.5, 1, 2, 4, 8 and 12 hours postdose ]
  Show Outcome Measure 8

9.  Secondary:   Accumulation Ratio for Cmax (Rac Cmax) and Accumulation Ratio for AUCtau (Rac AUCtau): Multiple Dose   [ Time Frame: Multiple dose Cycle 1 Day 1 and 15: predose, 0.5, 1, 2, 4, 8 and 12 hours postdose ]
  Show Outcome Measure 9

10.  Secondary:   Percent Change From Baseline in Soluble Vascular Endothelial Growth Factor Receptor 2 and 3 (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), Day 1 of Cycle 2 and at the discontinuation ]
  Hide Outcome Measure 10

Measure Type Secondary
Measure Title Percent Change From Baseline in Soluble Vascular Endothelial Growth Factor Receptor 2 and 3 (s-VEGFR2 and s-VEGFR3), Vascular Endothelial Growth Factor (VEGF), Soluble Stem Cell Factor Receptor (s-KIT)
Measure Description Percent change from baseline is obtained from (observed value minus baseline value) divided by baseline value multiplied by 100 in each parameter, i.e., VEGFR2, s-VEGFR3, s-KIT, and VEGF.
Time Frame Prior to the initial dose (baseline), Day 1 of Cycle 2 and at the discontinuation  
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.
Participants who received at least one study drug and completed pharmacodynamic blood sampling for at least one day (Pharmacodynamic Analysis Set); n= number of participants assessed.

Reporting Groups
  Description
AG-013736

Single dose (first 6 participants only): Single AG-013736 5 mg was administered orally.

Multiple dose (all participants): AG-013736 5 mg twice daily (BID) was administered orally in fed state, 12 hours apart at approximately the same time each day. AG-013736 dose was titrated or reduced based on the dose modification criteria: the available dose was 2, 3, 5, 7, or 10 mg at a time. One cycle length was 28 days and participants continued the study treatment until intolerable toxicity or disease progression occurred.

Measured Values
    AG-013736  
Number of Participants Analyzed  
[units: participants]
 		  12  
Percent Change From Baseline in Soluble Vascular Endothelial Growth Factor Receptor 2 and 3 (s-VEGFR2 and s-VEGFR3), Vascular Endothelial Growth Factor (VEGF), Soluble Stem Cell Factor Receptor (s-KIT)  
[units: percent change]
Median ( Full Range ) 		 
s-VEGFR2: Cycle 2 Day 1 (n=12)     -41.73  
  ( -53.2 to -10.1 )  
s-VEGFR2: At discontinuation (n=11)     -40.57  
  ( -53.0 to -8.4 )  
s-VEGFR3: Cycle 2 Day 1 (n=12)     -52.50  
  ( -93.7 to -15.6 )  
s-VEGFR3: At discontinuation (n=11)     -65.48  
  ( -81.2 to 39.4 )  
s-KIT: Cycle 2 Day 1 (n=12)     -0.26  
  ( -23.8 to 33.5 )  
s-KIT: At discontinuation (n=11)     4.66  
  ( -31.2 to 12.9 )  
VEGF: Cycle 2 Day 1 (n=12)     266.92  
  ( 14.9 to 1030.4 )  
VEGF: At discontinuation (n=11)     43.48  
  ( -15.5 to 423.1 )  

No statistical analysis provided for Percent Change From Baseline in Soluble Vascular Endothelial Growth Factor Receptor 2 and 3 (s-VEGFR2 and s-VEGFR3), Vascular Endothelial Growth Factor (VEGF), Soluble Stem Cell Factor Receptor (s-KIT)



11.  Secondary:   The Numbers 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 795 days ]
  Show Outcome Measure 11


  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: NCT00447005     History of Changes
Other Study ID Numbers: A4061022
Study First Received: March 12, 2007
Results First Received: February 25, 2012
Last Updated: May 17, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare