Description:
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.
Title
- Brief Title: Study to Evaluate the Safety and Efficacy of Sunitinib, in Subject With Refractory Solid Tumors
- Official Title: Study to Evaluate the Safety and Efficacy of Sunitinib, in Subject With Refractory Solid Tumors
Clinical Trial IDs
- ORG STUDY ID:
2016-02-098
- NCT ID:
NCT02691793
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Sunitinib | | sunitinib |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
sunitinib | Experimental | sunitinib 50 mg will be administered orally daily | |
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 19 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | progression-free survival |
Time Frame: | 24 months |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | overall response rate |
Time Frame: | 24 months |
Safety Issue: | |
Description: | |
Measure: | Time to progression |
Time Frame: | 24 months |
Safety Issue: | |
Description: | |
Measure: | overall survival |
Time Frame: | 24 months |
Safety Issue: | |
Description: | |
Measure: | Number of subjects with adverse events as a measure of safety |
Time Frame: | 24 months |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 4 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Samsung Medical Center |
Last Updated
December 30, 2019