Study to Evaluate the Safety and Efficacy of Sunitinib, in Subject With Refractory Solid Tumors

Study Overview
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Brief Summary
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This study is a single arm, pilot study of Sunitinib in patient with RET fusion positive, FGFR2 fusion/FGFR mutation Refractory solid tumor and/or specific sensitivity to Sunitinib by Avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy. To investigate the efficacy and safety of Sunitinib in patient with Refractory solid tumor.

Official Title
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Study to Evaluate the Safety and Efficacy of Sunitinib, in Subject With Refractory Solid Tumors

Conditions
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Refractory Solid Tumors

Intervention / Treatment
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* Drug: Sunitinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of fully informed consent prior to study specific procedures. Patients must be >= 19 years of age RET fusion positive or FGFR2 fusion/other FGFR mutation Refractory solid tumor and/or specific sensitivity to Sunitinib by Avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy. ECOG Performance status0-2 Have measurable or evaluated disease based on RECIST 1.1 as determined by investigator. Adequate Organ Function Laboratory values Absolute neutrophil count >= 1.5 x 109/L, Hemoglobin >= 9g/dL, Platelets>=100 x 109/L Bilirubin <= 1.5 x upper limit of normal AST/ALT <= 2.5 X upper limit of normal(5.0 x upper limit of normal, for subject with liver metastases) Creatinine<= 1.5 X UNL Patients of child-bearing potential should be using adequate contraceptive measures should not be breast feeding and must have a negative pregnancy test prior to start of dosing Adequate heart function Exclusion Criteria: Patients with second primary cancer, except:adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumor curatively treated with no evidence of disease for <= 5 years. Has known active central nervous system(CNS) metastases Has an active infection requiring systemic therapy Pregnancy or breast feeding Patients with cardiac problem Any previous treatment with sunitinib

Ages Eligible for Study
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Minimum Age: 19 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: sunitinib<br>sunitinib 50 mg will be administered orally daily | Drug: Sunitinib<br>* sunitinib 37.5mg QD<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall response rate |  | 24 months | 
| Time to progression |  | 24 months | 
| overall survival |  | 24 months | 
| Number of subjects with adverse events as a measure of safety |  | 24 months |