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Five Year Adjuvant Imatinib Mesylate (Gleevec®) in Gastrointestinal Stromal Tumor (GIST)

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ClinicalTrials.gov Identifier: NCT00867113
Recruitment Status : Completed
First Posted : March 23, 2009
Results First Posted : March 14, 2018
Last Update Posted : March 14, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Gastrointestinal Stromal Tumor (GIST)
Intervention: Drug: imatinib mesylate

  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
Total of 113 subjects were screened and 91 were enrolled..

Reporting Groups
  Description
Imatinib All subjects received in tablet form imatinib (STI571) 400 mg once daily.

Participant Flow for 2 periods

Period 1:   Treatment Period
    Imatinib
STARTED   91 
Safety Set   91 
Full Analysis Set (FAS)   91 
COMPLETED   46 
NOT COMPLETED   45 
Adverse Event                15 
Death                2 
Withdrawal by Subject                19 
Lost to Follow-up                3 
Administrative problems                1 
Disease progression/relapse                1 
Protocol Violation                4 

Period 2:   Post Treatment After Survival Follow-up
    Imatinib
STARTED   68 
COMPLETED   57 
NOT COMPLETED   11 
Death                1 
Withdrawal by Subject                1 
Lost to Follow-up                5 
Administrative problems                4 



  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.
No text entered.

Reporting Groups
  Description
Imatinib All subjects received in tablet form imatinib (STI571) 400 mg once daily.

Baseline Measures
   Imatinib 
Overall Participants Analyzed 
[Units: Participants]
 91 
Age 
[Units: Years]
Mean (Standard Deviation)
 58.9  (12.64) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      43  47.3% 
Male      48  52.7% 
ECOG Status [1] 
[Units: Participants]
Count of Participants
 
ECOG = 0      59  64.8% 
ECOG = 1      32  35.2% 
[1] ECOG 0 = Fully active, able to carry on all pre-disease performance without restriction; ECOG 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; ECOG 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours; ECOG 3 = Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours; ECOG 4 = Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair; ECOG 5 = Dead.
Primary lesion location [1] 
[Units: Participant]
 
Gastric   50 
Duodenum   4 
Jejunum ileum   21 
Rectum   1 
Other   15 
Abdomen   1 
Abdominal; Proximal Jejunal   1 
Exact Location In Small Bowel Not Identified   1 
Gastric Serosa-Min Invasion Outer Musc Prop   1 
Ileum And Cecum   1 
Pelvis - Organ Of Origin Unknown   1 
Recto Vaginal   1 
Retroperitoneal Mass   1 
Sigmoid Colon   1 
Small Bowel   6 
[1] Primary lesion


  Outcome Measures

1.  Primary:   Recurrence-free Survival up to 60 Months   [ Time Frame: Baseline up to 60 months ]

2.  Primary:   Kaplan-Meier Estimates for Recurrence-free Survival up to 60 Months   [ Time Frame: Baseline up to 60 months ]

3.  Secondary:   Overall Survival (OS) at 60 Months   [ Time Frame: Baseline up to approximately 60 months ]

4.  Secondary:   Kaplan-Meier Estimates for Overall Survival (OS) up to 60 Months   [ Time Frame: Baseline up to appoximately 60 months ]


  Serious Adverse Events


  Other Adverse Events


  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

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 Pharmaceuticals
phone: 862-778-8300
e-mail: Novartis.email@novartis.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00867113     History of Changes
Other Study ID Numbers: CSTI571BUS282
First Submitted: March 20, 2009
First Posted: March 23, 2009
Results First Submitted: December 15, 2017
Results First Posted: March 14, 2018
Last Update Posted: March 14, 2018