Nilotinib 800 Mg And Imatinib 800 Mg For The Treatment Of Patients With Gastrointestinal Stromal Tumors (Gist) Refractory To Imatinib 400 Mg (MACS0375)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00751036
First received: September 9, 2008
Last updated: February 25, 2014
Last verified: February 2014
Results First Received: October 29, 2013  
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 Tumors
Interventions: Drug: Nilotinib
Drug: Imatinib

  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
Nilotinib Patients who were assigned to this treatment group received 400 mg. nilotinib bid.
Imatinib Patients who were assigned to this treatment group received 400 mg. imatinib bid.

Participant Flow:   Overall Study
    Nilotinib     Imatinib  
STARTED     48 [1]   46 [1]
COMPLETED     0 [2]   0 [2]
NOT COMPLETED     48     46  
Disease Progression                 28                 29  
Adverse Event                 6                 4  
Administrative Problems                 3                 4  
Withdrawal by Subject                 5                 2  
Death                 3                 3  
Lost to Follow-up                 0                 1  
Protocol Violation                 1                 0  
Missing end of Treatment Page                 2                 3  
[1] Started = Treated
[2] Reason Not Completed = Reason for End of Treatment



  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
Nilotinib Patients who were assigned to this treatment group received 400 mg. nilotinib bid.
Imatinib Patients who were assigned to this treatment group received 400 mg. imatinib bid.
Total Total of all reporting groups

Baseline Measures
    Nilotinib     Imatinib     Total  
Number of Participants  
[units: participants]
  48     46     94  
Age, Customized  
[units: Participants]
     
<65 years     38     35     73  
≥ 65 years     9     11     20  
Missing     1     0     1  
Gender  
[units: Participants]
     
Female     28     19     47  
Male     20     27     47  



  Outcome Measures
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1.  Primary:   Progression-free Survival (PFS)   [ Time Frame: 24 months ]

2.  Secondary:   Disease Control Rate (DCR)   [ Time Frame: every 2 months until 24 months (end of study) ]

3.  Secondary:   Time to Treatment Failure   [ Time Frame: Time from date of radomization to the earliest date of the first objective tumor, death or discontinuation, assesed until 24 months. ]

4.  Secondary:   Overall Survival (OS)   [ Time Frame: time from the date of randomization to the date of death due to any cause or the date of last contact prior to or on the date of data cutoff, assesed until 24 months. ]


  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
Patients were limited (planned 300, Actual 94). Early termination of study; not sufficient power to test the original primary hypothesis with respect to PFS. Only descriptive analyses were carried out for this study.  


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300


No publications provided


Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00751036     History of Changes
Other Study ID Numbers: CAMN107DBR01, 2010-019806-18
Study First Received: September 9, 2008
Results First Received: October 29, 2013
Last Updated: February 25, 2014
Health Authority: United States: Food and Drug Administration
Brazil: Ministry of Health
Mexico: Federal Commission for Protection Against Health Risks
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Panama: Ministry of Health
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Venezuela: Ministry of Health and Social Development
China: Food and Drug Administration
South Korea: Korea Food and Drug Administration (KFDA)
Russia: Ministry of Health of the Russian Federation
Thailand: Food and Drug Administration
Canada: Health Canada