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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sunitinib | Experimental | sunitinib 50 mg will be administered orally daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sunitinib | Drug | sunitinib 37.5mg QD |
|
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| overall response rate | 24 months | |
| Time to progression | 24 months | |
| overall survival |
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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
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | Seoul, Korea, Republic of | 135-710 | South Korea |
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| ID | Term |
|---|---|
| D000077210 | Sunitinib |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| 24 months |
| Number of subjects with adverse events as a measure of safety | 24 months |
| D007211 |
| Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |