Nilotinib 800 Mg And Imatinib 800 Mg For The Treatment Of Patients With Gastrointestinal Stromal Tumors (Gist) Refractory To Imatinib 400 Mg (MACS0375)
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|ClinicalTrials.gov Identifier: NCT00751036|
Recruitment Status : Terminated
First Posted : September 11, 2008
Results First Posted : March 26, 2014
Last Update Posted : March 26, 2014
|Condition or disease||Intervention/treatment||Phase|
|Gastrointestinal Stromal Tumors||Drug: Nilotinib Drug: Imatinib||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||94 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Phase III Trial Comparing Nilotinib 800mg to Imatinib 800 mg for the Treatment of Patients With Advanced and/or Metastatic Gastrointestinal Stromal Tumors Refractory to Imatinib 400 mg|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||August 2012|
U.S. FDA Resources
Patients who were assigned to this treatment group received 400 mg. nilotinib bid.
Nilotinib hard gel capsules were supplied to the Investigators at dose strengths of 200 mg. Nilotinib is a novel agent, which has been approved for the treatment of chronic phase and accelerated phase Philadelphia-chromosome-positive CML in adult patients resistant to or intolerant to prior therapy that included imatinib.
Other Name: Tasigna
Active Comparator: Imatinib
Patients who were assigned to this treatment group received 400 mg. imatinib bid.
Imatinib tablets were supplied at 100 mg and/or 400 mg dose strength. Imatinib is an approved agent for GIST. Efficacy of imatinib at a dose of 400 mg bid has been established in the setting of disease progression after the use of the conventional dose (400 mg qd).
- Progression-free Survival (PFS) [ Time Frame: 24 months ]Progression-free survival (PFS) is the time from date of randomization to the date of first documented progression or death due to any cause. If a participant has not had an event, progression-free survival is censored at the time of last adequate tumor assessment. Progression is defined according to modified RECIST criteria as at least a 20% increase in the sum of the longest diameter of target lesions, worsening of the non-target lesions or the appearance of one or more new lesions.
- Disease Control Rate (DCR) [ Time Frame: every 2 months until 24 months (end of study) ]The Disease Control Rate (Complete Response(CR), Partial Response (PD) and Stable Disease (SD) rates for each treatment arm will be computed using the exact Clopper-Pearson interval estimation methodology. DCR is defined as the percentage of patients with a best overall response of • CR, i.e. at least two determinations of CR at least 4 weeks apart without loss of response between the determinations, • PR, i.e. at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR) and without loss of PR between the determinations, or • SD lasting at least 24 weeks, i.e. at least one SD or better response at least 24 weeks after randomization (and not qualifying for CR or PR).
- 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. ]TTF, defined as the time from date of randomization to the earliest of date of the first objective tumor progression, date of death due to any cause, or date of discontinuation due to reasons other than 'Protocol deviation' or 'Administrative problems'.
- 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. ]. OS is defined as the 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. The median time to overall survival and its associated 95 % CI will be derived, for each treatment arm, using the time to event analysis based on Kaplan-Meier methodology.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00751036
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|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|