A Study of the Efficacy and Safety of Imatinib Mesylate in Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumors Expressing C-kit Gene

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00237185
First received: October 9, 2005
Last updated: August 14, 2014
Last verified: August 2014
Results First Received: June 13, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Unresectable or Metastatic Malignant Gastrointestinal Stromal Tumor (GIST)
Intervention: 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
No text entered.

Reporting Groups
  Description
Imatinib Mesylate 400 mg imatinib mesylate 400 mg once daily
Imatinib Mesylate 600 mg imatinib mesylate 600 mg once daily

Participant Flow for 2 periods

Period 1:   Core
    Imatinib Mesylate 400 mg     Imatinib Mesylate 600 mg  
STARTED     74     74  
Treated Participants     73     74  
COMPLETED     30     37  
NOT COMPLETED     44     37  
Adverse Event                 3                 4  
Abnormal laboratory value                 0                 4  
Abnormal test procedure results                 1                 0  
Lack of Efficacy                 30                 23  
Protocol Violation                 1                 1  
Withdrawal by Subject                 4                 4  
Administrative problems                 0                 1  
Death                 4                 0  
Determined ineligible post randomization                 1                 0  

Period 2:   Extension
    Imatinib Mesylate 400 mg     Imatinib Mesylate 600 mg  
STARTED     24 [1]   32 [1]
COMPLETED     8     13  
NOT COMPLETED     16     19  
Adverse Event                 1                 0  
Abnormal laboratory value                 0                 1  
Lack of Efficacy                 9                 14  
Condition no longer required study drug                 0                 1  
Withdrawal by Subject                 3                 2  
Lost to Follow-up                 1                 0  
Administrative problems                 1                 0  
Death                 1                 1  
[1] A portion of the participants, who completed the core, entered the extension.



  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
Imatinib Mesylate 400 mg

400 mg

Imatinib mesylate

Imatinib Mesylate 600 mg

600 mg

Imatinib mesylate

Total Total of all reporting groups

Baseline Measures
    Imatinib Mesylate 400 mg     Imatinib Mesylate 600 mg     Total  
Number of Participants  
[units: participants]
  73     74     147  
Age  
[units: Years]
Mean ± Standard Deviation
  56.6  ± 12.9     52.2  ± 11.12     54.4  ± 12.2  
Gender  
[units: participants]
     
Female     29     35     64  
Male     44     39     83  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Best Tumor Response (Core)   [ Time Frame: Month 36 ]

2.  Primary:   Best Tumor Response (Core + Extension)   [ Time Frame: Month 156 ]

3.  Secondary:   Overall Survival (Core)   [ Time Frame: Date of first imatinib dose to the date of death during the core period, up to 36 months. ]

4.  Secondary:   Overall Survival (Core + Extension)   [ Time Frame: Date of first imatinib dose to the date of death during the core and extension periods, up to 156 months. ]

5.  Secondary:   Duration of Response (Core)   [ Time Frame: Date of confirmed best PR or CR to date of confirmed disease progression during the core period, up to 36 months. ]

6.  Secondary:   Duration of Response (Core + Extension)   [ Time Frame: Date of confirmed best PR or CR to date of confirmed disease progression during the core and extension periods, up to 156 months ]

7.  Secondary:   Progression Free Survival (PFS) (Core + Extension)   [ Time Frame: Date of first imatinib dose to earliest date of progression, resection due to safety/progression, death due to any cause or discontinuation due to unsatisfactory therapeutic effect during the core and extension periods, up to 156 months. ]

8.  Secondary:   Time to Treatment Failure (Core)   [ Time Frame: Date of first imatinib dose to date of earliest occurrence of progression, death due to any cause, or discontinuation from the trial for any reason other than the condition no longer required therapy during the core period, up to 36 months. ]

9.  Secondary:   Time to Treatment Failure (Core + Extension)   [ Time Frame: Date of first imatinib dose to date of earliest occurrence of progression, death due to any cause, or discontinuation from the trial for any reason other than the condition no longer required therapy during the core and extension periods, up to 156 month. ]

10.  Secondary:   Time to Onset of Response (Core)   [ Time Frame: Date of first imatinib dose to the date of the first tumor assessment that was later confirmed to be at least a partial response during the core period, up to 36 months. ]

11.  Secondary:   Time to Onset of Response (Core + Extension)   [ Time Frame: Date of first imatinib dose to the date of the first tumor assessment that was later confirmed to be at least a partial response during the core and extension periods, up to 156 months. ]

12.  Secondary:   Time to Progression (Core + Extension)   [ Time Frame: Date of first imatinib dose to date of progression or death due to disease indication or discontinuation due to unsatisfactory therapeutic effect during the core and extension periods, up to 156 months. ]


  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
No safety data was collected in the extension.


  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: Study Director
Organization: Novartis
phone: 862-778-8300


No publications provided


Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00237185     History of Changes
Other Study ID Numbers: CSTI571B2222, CSTI571B2222/E1
Study First Received: October 9, 2005
Results First Received: June 13, 2014
Last Updated: August 14, 2014
Health Authority: United States: Food and Drug Administration
Finland: Finnish Medicines Agency