Evaluation of Nilotinib In Patients With Advanced Gastrointestinal Stromal Tumor (GIST)

Study Overview
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Brief Summary
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This study will assess time-to-disease progression in patients with advanced gastrointestinal stromal tumor (GIST) previously treated with imatinib ≥600 mg.

Official Title
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Evaluation of Nilotinib In Patients With Advanced Gastrointestinal Stromal Tumor (GIST) Previously Treated With Imatinib

Conditions
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Gastrointestinal Stromal Tumor

Intervention / Treatment
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* Drug: Nilotinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed diagnosis of GIST that is unresectable and/or metastatic Radiological confirmation of disease progression or intolerance to imatinib therapy at a any dose At least one measurable site of disease on CT scan at Visit-2 WHO Performance Status of 0, 1 or 2 at Visit-2 Patients must have normal organ, electrolyte, and marrow function at Visit-1 and Visit-2 Exclusion Criteria: Prior treatment with nilotinib or any other tyrosine kinase inhibitors except imatinib. Treatment with any cytotoxic and/or investigational cytotoxic drug ≤ 4 weeks Prior or concomitant malignancies other than GIST Impaired cardiac function at Visit-1 or 2 Patients with severe and/or uncontrolled concurrent medical disease Use of therapeutic coumarin derivatives Use of any medications that prolong the QT interval Use of CYP3A4 inhibitors Patients who have undergone major surgery ≤ 2 weeks prior to Visit-1 or who have not recovered from side effects of such surgery Patients who have received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation < 2 weeks prior to Visit-1 or who have not recovered from side effects of such therapy 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nilotinib<br> | Drug: Nilotinib<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate time-to-disease progression in patients with advanced gastrointestinal stromal tumor (GIST) previously treated with imatinib ≥600 mg. |  | every 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine progression-free survival and the response rate of nilotinib in patients with advanced GIST previously treated with imatinib ≥600 mg. |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Unresectable, metastatic gastrointestinal stromal tumor, disease progression, progression-free survival