A Study of Nilotinib Versus Imatinib in GIST Patients

Study Overview
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Brief Summary
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This study will evaluate efficacy and safety of nilotinib versus imatinib in adult patients with unresectable or metastatic gastrointestinal stromal tumors (GIST).

Official Title
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A Randomized, Open Label, Multi-center Phase III Study to Evaluate the Efficacy and Safety of Nilotinib Versus Imatinib in Adult Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumors (GIST)

Conditions
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Gastrointestinal Stromal Tumor (GIST)

Intervention / Treatment
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* Drug: Nilotinib (AMN107)
* Drug: imatinib (STI571)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed diagnosis of GIST which is unresectable and/or metastatic and either: have not received any prior anti-neoplastic therapy other than adjuvant imatinib. Note: newly diagnosed patients may have received up to 14 days of treatment with imatinib for disease management while awaiting entry to the study or recurrent GIST after stopping adjuvant treatment with imatinib and no subsequent treatment with any other therapies. At least one measurable site of disease on CT/MRI scan Performance status ≤ 2 (capable of self-care but unable to carry out any work) Normal organ, electrolyte and marrow function Exclusion Criteria: Any prior anti-neoplastic therapy with the exception of patients who have received adjuvant imatinib or patients with newly diagnosed metastatic/ unresectable GIST whose disease requires therapy while awaiting entry to the study. Disease progression during adjuvant therapy with imatinib History of active malignancy (other than GIST) within 10 years prior to study entry with the exception of previous or concomitant basal cell skin cancer, previous cervical carcinoma in situ. Impaired cardiac function Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nilotinib<br>nilotinib 400 mg twice a day | Drug: Nilotinib (AMN107)<br> <br> |
| Active Comparator: Imatinib<br>imatinib 400 mg once daily | Drug: imatinib (STI571)<br> <br> * Other names: Glivec/Gleevec;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Progression Free Survival (PFS) | PFS was defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions | up to month 37 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Unresectable GIST, metastatic GIST, nilotinib, AMN107, imatinib, STI571