Safety And Efficacy Study Of Sunitinib Malate In Chinese Patients With Imatinib Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor (GIST)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00793871
First received: November 17, 2008
Last updated: May 4, 2015
Last verified: May 2015
Results First Received: April 14, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Gastrointestinal Neoplasms, Gastrointestinal Stromal Tumors
Intervention: Drug: Sunitinib Malate (SU011248)

  Participant Flow
  Hide Participant Flow

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
Sutent (Sunitinib Malate) The starting dose of sunitinib was 50 milligram (mg) orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (schedule 4/2). Participants experiencing dose-limiting toxicity attributed to study medication had dose interrupted or reduced depending on individual tolerability. If dose reductions were required, the dose of 37.5 mg was achieved by administration of 3 × 12.5 mg capsules, and the dose of 25 mg was achieved by administration of 2 × 12.5 mg capsules. There was no limit for number of cycles for this study, study treatment was permanently discontinued upon disease progression, occurrence of unacceptable toxicity, withdrawal of participant consent, or another withdrawal criterion was met.

Participant Flow:   Overall Study
    Sutent (Sunitinib Malate)  
STARTED     60  
Received Treatment     59  
COMPLETED     0  
NOT COMPLETED     60  
Death                 50  
Lost to Follow-up                 3  
Study terminated by the Sponsor                 7  



  Baseline Characteristics
  Hide Baseline Characteristics

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.
Safety analysis set included all participants who started study treatment.

Reporting Groups
  Description
Sutent (Sunitinib Malate) The starting dose of sunitinib was 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (schedule 4/2). Participants experiencing dose-limiting toxicity attributed to study medication had dose interrupted or reduced depending on individual tolerability. If dose reductions were required, the dose of 37.5 mg was achieved by administration of 3 × 12.5 mg capsules, and the dose of 25 mg was achieved by administration of 2 × 12.5 mg capsules. There was no limit for number of cycles for this study, study treatment was permanently discontinued upon disease progression, occurrence of unacceptable toxicity, withdrawal of participant consent, or another withdrawal criterion was met.

Baseline Measures
    Sutent (Sunitinib Malate)  
Number of Participants  
[units: participants]
  59  
Age  
[units: years]
Mean (Standard Deviation)
  55.1  (12.2)  
Gender  
[units: Participants]
 
Female     20  
Male     39  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression-free Survival (PFS)   [ Time Frame: Baseline (Day 1) up to disease progression or death whichever occurred first (up to 264 weeks) ]

2.  Secondary:   Overall Survival (OS)   [ Time Frame: Baseline (Day 1) to death (up to 282 weeks) ]

3.  Secondary:   Objective Response Rate (ORR)   [ Time Frame: Baseline (Day 1) up to end of study treatment (up to 276 weeks) ]

4.  Secondary:   Time to Tumor Progression (TTP)   [ Time Frame: Baseline (Day 1) up to objective tumor progression or death due to tumor progression (up to 264 weeks) ]

5.  Secondary:   Number of Participants With Abnormal Clinical Laboratory Measurements   [ Time Frame: Baseline up to 28 days post last administration of study drug ]

6.  Secondary:   Number of Participants With Significant Changes From Baseline in Physical Examination.   [ Time Frame: Baseline up to 28 days post last administration of study drug ]

7.  Secondary:   Number of Participants With Significant Vital Signs Changes From Baseline   [ Time Frame: Baseline (Day 1) up to 28 days post last administration of study drug ]

8.  Secondary:   Eastern Cooperative Oncology Group (ECOG) Performance Status   [ Time Frame: Baseline (Day 1), Last-on treatment visit (up to 28 days post last administration of study drug) ]

9.  Other Pre-specified:   Time to Tumor Response (TTR)   [ Time Frame: Baseline (Day 1) to tumor response (up to 82 weeks) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


  More Information
  Hide More Information

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: NCT00793871     History of Changes
Other Study ID Numbers: A6181177
Study First Received: November 17, 2008
Results First Received: April 14, 2015
Last Updated: May 4, 2015
Health Authority: United States: Food and Drug Administration