Study Of Sunitinib With Capecitabine In Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00662025
First received: April 17, 2008
Last updated: May 22, 2013
Last verified: May 2013
Results First Received: September 20, 2010  
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: Advanced/Metastatic Breast Cancer
Interventions: Drug: Capecitabine
Drug: Sunitinib

  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
The study consisted of 2 cohorts. Cohort 1 enrolled 6 participants. All adverse events in Cohort 1 were evaluated at the end of Cycle 2, and study continuation to Cohort 2 was determined based on the recommendation from the Independent Safety Monitoring Committee. Cohort 2 consisted of 63 participants, including the 6 participants in Cohort 1.

Reporting Groups
  Description
SUNITINIB+CAPECITABINE Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.

Participant Flow:   Overall Study
    SUNITINIB+CAPECITABINE  
STARTED     63 [1]
COMPLETED     0  
NOT COMPLETED     63  
Objective progression or relapse                 51  
Adverse Event                 7  
Withdrawal by Subject                 1  
Results of other clinical study                 2  
Target lesion cannot be evaluated                 1  
Domestic circumstances                 1  
[1] All 63 participants were included in Full Analysis Set population.



  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
SUNITINIB+CAPECITABINE Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.

Baseline Measures
    SUNITINIB+CAPECITABINE  
Number of Participants  
[units: participants]
  63  
Age  
[units: years]
Mean ( Full Range )
  52.9  
  ( 26 to 76 )  
Age, Customized  
[units: participants]
 
>=20 years and 44 years >=     13  
>=45 years and 64 years >=     43  
>=65 years     7  
Gender  
[units: participants]
 
Female     63  
Male     0  
Eastern Cooperative Oncology Group (ECOG) Performance Status [1]
[units: participants]
 
Score 0     57  
Score 1     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, e.g., light house work, office work.




  Outcome Measures
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1.  Primary:   Number of Participants With Objective Response Based on Data Review Committee's Assessment   [ Time Frame: Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8. ]

2.  Secondary:   Number of Participants With Objective Response Based on Investigator's Assessment   [ Time Frame: Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of study. ]

3.  Secondary:   Number of Participants With Clinical Benefit Response (CBR) Based on Data Review Committee's Assessment   [ Time Frame: Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8. ]

4.  Secondary:   Number of Subjects With CBR Based on Investigator's Assessment   [ Time Frame: Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of study. ]

5.  Secondary:   Progression-Free Survival (PFS)   [ Time Frame: Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8. Up to 28 days after the last administration of the study drug. ]

6.  Secondary:   Time to Tumor Progression (TTP)   [ Time Frame: Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8. Up to 28 days after the last administration of the study drug. ]

7.  Secondary:   Duration of Objective Tumor Response (DR)   [ Time Frame: Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8. Up to 28 days after the last administration of the study drug. ]

8.  Secondary:   Time to Objective Tumor Response (TTR)   [ Time Frame: Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8. Up to 28 days after the last administration of the study drug. ]

9.  Secondary:   Overall Survival (OS)   [ Time Frame: A survival survey was conducted at least every 6 months after the completion of study treatment or withdrawal from the study. ]

10.  Secondary:   Trough Plasma Concentration (Ctrough) for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662)   [ Time Frame: Days 14 and 15 of Cycle 1 ]

11.  Secondary:   Tmax for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662)   [ Time Frame: Days 14 and 15 of Cycle 1 ]

12.  Secondary:   Cmax for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662)   [ Time Frame: Days 14 and 15 of Cycle 1 ]

13.  Secondary:   AUC(0-24) for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662)   [ Time Frame: Days 14 and 15 of Cycle 1 ]

14.  Secondary:   Tmax for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU)   [ Time Frame: Day 14 of Cycle 1 ]

15.  Secondary:   Cmax for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU)   [ Time Frame: Day 14 of Cycle 1 ]

16.  Secondary:   AUC(0-inf) for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU)   [ Time Frame: Day 14 of Cycle 1 ]

17.  Secondary:   t1/2 for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU)   [ Time Frame: Day 14 of Cycle 1 ]


  Serious Adverse Events


  Other Adverse Events


  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


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00662025     History of Changes
Other Study ID Numbers: A6181163
Study First Received: April 17, 2008
Results First Received: September 20, 2010
Last Updated: May 22, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare