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A Safety Study Of Sunitinib In Combination With Pemetrexed In Patients With Advanced Solid Malignancies

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00732992
First received: August 8, 2008
Last updated: March 15, 2011
Last verified: March 2011
History of Changes
Results First Received: October 27, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Neoplasm, Malignant
Intervention: Drug: Sunitinib, Pemetrexed

  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
Sunitinib 37.5 mg/Day Continuous Daily Dosing Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.
Sunitinib 50 mg/Day Schedule-2/1

Sunitinib 50.0 mg was administered continuously on a daily basis for 2 weeks, followed by 1 week off treatment.

Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.

Participant Flow:   Overall Study
    Sunitinib 37.5 mg/Day Continuous Daily Dosing     Sunitinib 50 mg/Day Schedule-2/1  
STARTED     6     6  
COMPLETED     0     0  
NOT COMPLETED     6     6  
Adverse Event                 1                 1  
Objective Progression or Relapse                 3                 5  
Global Deterioration of Health Status                 1                 0  
Withdrawal by Subject                 1                 0  



  Baseline Characteristics
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Reporting Groups
  Description
Sunitinib 37.5 mg/Day Continuous Daily Dosing Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.
Sunitinib 50 mg/Day Schedule-2/1

Sunitinib 50.0 mg was administered continuously on a daily basis for 2 weeks, followed by 1 week off treatment.

Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.
Total Total of all reporting groups

Baseline Measures
    Sunitinib 37.5 mg/Day Continuous Daily Dosing     Sunitinib 50 mg/Day Schedule-2/1     Total  
Number of Participants  
[units: participants]
 		  6     6     12  
Age, Customized  
[units: Participants]
 		     
20-44 years     0     0     0  
45- 64 years     4     2     6  
>=65 years     2     4     6  
Gender  
[units: Participants]
 		     
Female     0     2     2  
Male     6     4     10  
Eastern Cooperative Oncology Group (ECOG) Performance Status [1]
[units: Participants]
 		     
Score 0     2     4     6  
Score 1     4     2     6  
[1] Score 0: Fully active, able to carry on all pre-disease performance without restriction; Score 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, such as light house work and office work.



  Outcome Measures
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1.  Primary:   Number of Participants With Adverse Events   [ Time Frame: End of study (up to individual discontinuation) ]
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2.  Secondary:   Sunitinib Relative Dose Intensity in the "Sunitinib 37.5 mg/Day Continuous Daily Dosing" Treatment Arm   [ Time Frame: Up to Cycle 5 (end of study) ]
  Hide Outcome Measure 2

Measure Type Secondary
Measure Title Sunitinib Relative Dose Intensity in the "Sunitinib 37.5 mg/Day Continuous Daily Dosing" Treatment Arm
Measure Description Relative dose intensity was defined as percentage of total dose administered over total planned dose in the given period.
Time Frame Up to Cycle 5 (end of study)  
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.
Full analysis set = defined as "all enrolled patients". n = number of participants assessed for the relative dose intensity in the given period.

Reporting Groups
  Description
Sunitinib 37.5 mg/Day Continuous Daily Dosing Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.

Measured Values
    Sunitinib 37.5 mg/Day Continuous Daily Dosing  
Number of Participants Analyzed  
[units: participants]
 		  6  
Sunitinib Relative Dose Intensity in the "Sunitinib 37.5 mg/Day Continuous Daily Dosing" Treatment Arm  
[units: percent of total planned dose]
Median ( Full Range ) 		 
Cycle 1 (n=6)     92.0  
  ( 75.9 to 100 )  
Cycle 2 (n=6)     54.8  
  ( 4.8 to 100 )  
Cycle 3 (n=4)     46.0  
  ( 14.9 to 95.2 )  
Cycle 4 (n=4)     55.6  
  ( 41.4 to 104.8 )  
Cycle 5 (n=1)     44.4  
  ( 44.4 to 44.4 )  

No statistical analysis provided for Sunitinib Relative Dose Intensity in the "Sunitinib 37.5 mg/Day Continuous Daily Dosing" Treatment Arm



3.  Secondary:   Sunitinib Relative Dose Intensity in the "Sunitinib 50 mg/Day Schedule-2/1" Treatment Arm   [ Time Frame: Up to Cycle 6 ]
  Show Outcome Measure 3

4.  Secondary:   Trough and Maximum Concentration of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1   [ Time Frame: Cycle 2 Day 1: Pre-dose and 2, 4, 6, 8, 10, and 24 hours post-dose ]
  Show Outcome Measure 4

5.  Secondary:   AUC 0-24 of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1   [ Time Frame: Cycle 2 Day 1: Pre-dose and 2, 4, 6, 8, 10, and 24 hours post-dose ]
  Show Outcome Measure 5

6.  Secondary:   Tmax of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1   [ Time Frame: Cycle 2 Day 1: Pre-dose and 2, 4, 6, 8, 10, and 24 hours post-dose ]
  Show Outcome Measure 6

7.  Secondary:   Maximum Concentration of Pemetrexed Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1   [ Time Frame: Cycle 2 Day 1: Pre-dose, 10 minutes after the start of infusion (immediately before the end of infusion), and 1, 2, 4, 6, 8, 10, and 24 hours post-dose ]
  Show Outcome Measure 7

8.  Secondary:   AUC0-∞ of Pemetrexed Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1   [ Time Frame: Cycle 2 Day 1: Pre-dose, 10 minutes after the start of infusion (immediately before the end of infusion), and 1, 2, 4, 6, 8, 10, and 24 hours post-dose ]
  Show Outcome Measure 8

9.  Secondary:   Terminal Phase Elimination Half-Life (T1/2) of Pemetrexed Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1   [ Time Frame: Cycle 2 Day 1: Pre-dose, 10 minutes after the start of infusion (immediately before the end of infusion), and 1, 2, 4, 6, 8, 10, and 24 hours post-dose ]
  Show Outcome Measure 9

10.  Secondary:   Trough Concentrations of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) After Coadministration of Sunitinib 50 mg/Day and Pemetrexed 500 mg/m^2 (Cycle 1 Day 1), Followed by Sunitinib 50 mg/Day on Schedule-2/1 at Cycle 1 Day 14 or 15   [ Time Frame: Cycle 1 Day 14 (or 15): approximately 24 hours after the previous dose ]
  Show Outcome Measure 10

11.  Secondary:   Summary of Best Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST): Number of Participants   [ Time Frame: End of study (Up to individual study discontinuation) ]
  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: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00732992     History of Changes
Other Study ID Numbers: A6181165
Study First Received: August 8, 2008
Results First Received: October 27, 2010
Last Updated: March 15, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency