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

Samsung Medical Center1 site in 1 country1 target enrollmentNovember 20, 2017

ConditionsRefractory Solid Tumors

InterventionsSunitinib

DrugsSunitinib

Overview

Phase: Phase 4
Intervention: Sunitinib
Conditions: Refractory Solid Tumors
Sponsor: Samsung Medical Center
Enrollment: 1
Locations: 1
Primary Endpoint: progression-free survival
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

November 20, 2017

End Date

November 19, 2019

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Samsung Medical Center

Responsible Party

Principal Investigator

Seung tae Kim,PhMD

Principal Investigator

Samsung Medical Center

Eligibility Criteria

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