Safety And Effectiveness Of Daily Dosing With Sunitinib Or Imatinib In Patients With Gastrointestinal Stromal Tumors

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00372567
First received: September 5, 2006
Last updated: March 15, 2011
Last verified: March 2011
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: Gastrointestinal Stromal Tumor
Interventions: Drug: sunitinib malate
Drug: imatinib mesylate

  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
12 participants were enrolled in a lead-in Phase 1 safety sub-study, all of whom received Sunitinib 37.5 milligram (mg) 24 hours after the last dose of imatinib. No efficacy evaluations were planned/conducted for this sub-study.

Reporting Groups
  Description
Sunitinib (Phase 3) Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
Imatinib Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
Sunitinib (Phase 1) Single 37.5 mg dose administered 24 hours after the last dose of imatinib

Participant Flow for 2 periods

Period 1:   Phase 1 Sub-study
    Sunitinib (Phase 3)     Imatinib     Sunitinib (Phase 1)  
STARTED     0     0     12  
COMPLETED     0     0     12  
NOT COMPLETED     0     0     0  

Period 2:   Phase 3 Study
    Sunitinib (Phase 3)     Imatinib     Sunitinib (Phase 1)  
STARTED     31     26     12  
Received Treatment     31     25     12  
COMPLETED     0     0     0  
NOT COMPLETED     31     26     12  
Adverse Event                 5                 1                 1  
Death                 1                 1                 0  
Protocol Violation                 0                 0                 1  
Objective progression or relapse                 10                 13                 4  
Global deterioration of health status                 0                 1                 0  
not specified                 2                 2                 1  
study terminated by sponsor                 13                 8                 5  



  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 (Phase 3) Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
Imatinib Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
Sunitinib (Phase 1) Single 37.5 mg dose administered 24 hours after the last dose of imatinib
Total Total of all reporting groups

Baseline Measures
    Sunitinib (Phase 3)     Imatinib     Sunitinib (Phase 1)     Total  
Number of Participants  
[units: participants]
  31     26     12     69  
Age, Customized  
[units: participants]
       
less than 65 years     19     17     7     43  
greater than or equal to 65 years     12     9     5     26  
Gender  
[units: participants]
       
Female     11     11     5     27  
Male     20     15     7     42  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression-Free Survival (PFS)   [ Time Frame: Baseline, Week 5, and every 8 weeks until Year 2 ]

2.  Secondary:   Overall Survival (OS)   [ Time Frame: Baseline up to 2 years ]

3.  Secondary:   Time to Pain Relief Response (TTPR)   [ Time Frame: Day 28 of Cycle 1 up to 26 ]

4.  Secondary:   Time to Treatment Failure (TTF)   [ Time Frame: Day 28 of Cycle 1 up to 26 ]

5.  Secondary:   Number of Participants With Objective Response of Complete Response or Partial Response   [ Time Frame: Day 28 of Cycle 1 up to 26 ]

6.  Secondary:   Time to Tumor Response (TTR)   [ Time Frame: Day 28 of Cycle 1 up to 26 ]

7.  Secondary:   Duration of Response (DR)   [ Time Frame: Day 28 of Cycle 1 up to 26 ]

8.  Secondary:   Time to Pain Progression (TTPP)   [ Time Frame: Day 28 of Cycle 1 up to 26 ]

9.  Secondary:   Number of Participants With Pain Relief Response   [ Time Frame: Day 28 of Cycle 1 up to 26 ]

10.  Secondary:   Number of Participants With Pain Progression   [ Time Frame: Day 28 of Cycle 1 up to 26 ]

11.  Secondary:   Euro Quality of Life (EQ-5D) - Health State Profile Utility Score- Sunitinib Treatment Arm   [ Time Frame: Days 1 and 28 of each cycle ]

12.  Secondary:   Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Sunitinib Treatment Arm   [ Time Frame: Days 1 and 28 of each cycle ]

13.  Secondary:   Euro Quality of Life (EQ-5D) - Health State Profile Utility Score - Imatinib Treatment Arm   [ Time Frame: Days 1 and 28 of each cycle ]

14.  Secondary:   Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Imatinib Treatment Arm   [ Time Frame: Days 1 and 28 of each cycle ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
On 18 June 2009, the study was prematurely stopped for operational reasons (poor recruitment, lack of interest, and change of clinical practice) and not related to safety concerns


  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.


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: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00372567     History of Changes
Other Study ID Numbers: A6181112
Study First Received: September 5, 2006
Results First Received: October 27, 2010
Last Updated: March 15, 2011
Health Authority: United States: Food and Drug Administration