An International Phase 2 Study Of SU011248 In Patients With Advanced / Metastatic Gastric Cancer Failing Chemotherapy

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00226811
First received: September 23, 2005
Last updated: December 10, 2009
Last verified: December 2009
Results First Received: May 14, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Stomach Neoplasms
Intervention: 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
This study used a Simon 2-stage design with objective response rate (ORR) as the primary efficacy endpoint. Enrollment was halted after Part 1 Stage 2 because the minimum number of responding subjects required to proceed to Part 2 was not reached. Further subject enrollment therefore ended after 78 subjects had been enrolled and treated on Part 1.

Reporting Groups
  Description
50 mg Sunitinib Sunitinib was administered orally daily for 4 weeks followed by a 2-week off-treatment period (Schedule 4 weeks on drug / 2 weeks off) in each cycle. The starting dose was 50 mg daily with provision for dose interruption and/or reduction based on tolerability. All subjects received repeated cycles of sunitinib until disease progression, occurrence of unacceptable toxicity, withdrawal of subject consent, or other withdrawal criteria were met.

Participant Flow:   Overall Study
    50 mg Sunitinib  
STARTED     78  
COMPLETED     2  
NOT COMPLETED     76  
Death                 8  
Adverse Event                 11  
Lack of Efficacy                 55  
Withdrawal by Subject                 2  



  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
50 mg Sunitinib Sunitinib was administered orally daily for 4 weeks followed by a 2-week off-treatment period (Schedule 4 weeks on drug / 2 weeks off) in each cycle. The starting dose was 50 mg daily with provision for dose interruption and/or reduction based on tolerability. All subjects received repeated cycles of sunitinib until disease progression, occurrence of unacceptable toxicity, withdrawal of subject consent, or other withdrawal criteria were met.

Baseline Measures
    50 mg Sunitinib  
Number of Participants  
[units: participants]
  78  
Age  
[units: years]
Mean ± Standard Deviation
  55.1  ± 12.4  
Gender  
[units: participants]
 
Female     22  
Male     56  



  Outcome Measures
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1.  Primary:   Best Overall Response   [ Time Frame: From start of study treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter ]

2.  Primary:   Objective Response (Complete Response (CR) or Partial Response (PR))   [ Time Frame: From start of study treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter ]

3.  Secondary:   Clinical Benefit Response (CBR)-Complete Response (CR), Partial Response (PR) or Stable Disease (SD) With Duration ≥ 24 Weeks   [ Time Frame: From start of study treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter or clinical benefit response for at least 24 weeks on study ]

4.  Secondary:   Duration of Response (CR or PR)   [ Time Frame: Day 28 of Cycle 1 and Day 28 of Cycles thereafter or death due to cancer ]

5.  Secondary:   Progression-Free Survival   [ Time Frame: From start of study treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter or death ]

6.  Secondary:   Time to Tumor Progression (TTP)   [ Time Frame: From start of study treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter ]

7.  Secondary:   Overall Survival   [ Time Frame: From start of study treatment until death ]


  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.govCallCenter@pfizer.com


No publications provided


Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00226811     History of Changes
Other Study ID Numbers: A6181054
Study First Received: September 23, 2005
Results First Received: May 14, 2009
Last Updated: December 10, 2009
Health Authority: United States: Food and Drug Administration