A Study of Nilotinib Versus Imatinib in GIST Patients (ENESTg1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00785785
First received: November 4, 2008
Last updated: May 10, 2016
Last verified: May 2016
Results First Received: October 21, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Gastrointestinal Stromal Tumor (GIST)
Interventions: Drug: Nilotinib (AMN107)
Drug: imatinib (STI571)

  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 First, Then Nilotinib patients were on imatinib 400mg once daily in the core phase and then crossed over to nilotinib 400 mg twice a day in the extension phase
Nilotinib First, Then Imatinib patients were on nilotinib 400 mg twice a day in the core phase and then crossed over to in the extension phase imatinib 400mg once daily

Participant Flow for 2 periods

Period 1:   Core Phase up to 36 Months
    Imatinib First, Then Nilotinib     Nilotinib First, Then Imatinib  
STARTED     324     320  
COMPLETED     0     0  
NOT COMPLETED     324     320  
Patients didn't receive 1st line therapy                 3                 4  
Adverse Event                 31                 21  
Abnormal laboratory value                 1                 0  
Abnormal test procedure result                 2                 2  
Withdrawal by Subject                 16                 17  
Lost to Follow-up                 3                 7  
Administrative problems                 3                 3  
Death                 5                 8  
Disease progression                 139                 119  
Protocol deviation                 5                 6  
Study terminated by sponsor                 116                 133  

Period 2:   Optional Extension Phase
    Imatinib First, Then Nilotinib     Nilotinib First, Then Imatinib  
STARTED     39 [1]   125 [1]
COMPLETED     0     0  
NOT COMPLETED     39     125  
Adverse Event                 4                 5  
Withdrawal by Subject                 6                 6  
Lost to Follow-up                 1                 0  
Administrative problems                 2                 0  
Death                 1                 5  
Disease progression                 22                 70  
Protocol deviation                 0                 2  
Study terminated by sponsor                 3                 37  
[1] crossover extension phase was optional



  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 First, Then Nilotinib patients were on imatinib 400mg once daily in the core phase and then crossed over to nilotinib 400 mg twice a day in the extension phase
Nilotinib First, Then Imatinib patients were on nilotinib 400 mg twice a day in the core phase and then crossed over to in the extension phase imatinib 400mg once daily
Total Total of all reporting groups

Baseline Measures
    Imatinib First, Then Nilotinib     Nilotinib First, Then Imatinib     Total  
Number of Participants  
[units: participants]
  324     320     644  
Age  
[units: years]
Mean (Standard Deviation)
  57.4  (12.91)     57.3  (12.63)     57.35  (12.77)  
Gender  
[units: participants]
     
Female     145     133     278  
Male     179     187     366  



  Outcome Measures

1.  Primary:   Time to Progression Free Survival (PFS)   [ Time Frame: up to month 37 ]


  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
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  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 Pharmaceuticals
phone: 862-778-8300


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

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00785785     History of Changes
Other Study ID Numbers: CAMN107G2301
2008-004758-34 ( EudraCT Number )
Study First Received: November 4, 2008
Results First Received: October 21, 2015
Last Updated: May 10, 2016
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Austria: Federal Office for Safety in Health Care
Brazil: National Health Surveillance Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Canada: Health Canada
China: Food and Drug Administration
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Romania: State Institute for Drug Control
Denmark: Danish Medicines Agency
Egypt: Ministry of Health and Population
Finland: Finnish Medicines Agency
Germany: Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)
Greece: National Organization of Medicines
Hong Kong: Department of Health
Hungary: National Institute of Pharmacy
Israel: Ministry of Health
Italy: National Institute of Health
Japan: Pharmaceuticals and Medical Devices Agency
Korea: Food and Drug Administration
Mexico: Federal Commission for Protection Against Health Risks
Netherlands: Ministry of Health, Welfare and Sport
Norway: Norwegian Medicines Agency
Poland: Ministry of Health
Russia: Ministry of Health of the Russian Federation
Singapore: Health Sciences Authority
Slovakia: State Institute for Drug Control
South Africa: Department of Health
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Taiwan: Department of Health
Thailand: local IRB
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Venezuela:Instituto Nacional de Higiene "Rafael Rangel"