Single-arm Study to Evaluate the Safety and Efficacy of Sunitinib, in Subjects With RET Fusion Positive or FGFR2 Amplification, Refractory Solid Tumors
Overview
- Phase
- Not Applicable
- 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
Brief Summary
This is a pilot study of sunitinib in patients with RET fusion positive or FGFR2 Amplification Refractory solid tumors.
This study is a single-arm, pilot study of sunitinib in subjects with Refractory solid tumors harboring RET fusion positive or FGFR2 Amplification sunitinib 50mg will be administered orally once a day 42 days.Study treatment will be continued until objective disease progression.
To investigate the efficacy of sunitinib in subjects with Refractory solid tumors harboring RET fusion positive or FGFR2 Amplification.
Investigators
Joon Oh Park
MD,PhD
Samsung Medical Center
Eligibility Criteria
Inclusion Criteria
- •Provision of fully informed consent prior to any study specific procedures.
- •Patients must be ≥20 years of age.
- •RET fusion positive,FGFR amplification, Refractory Solid Tumors that has recurred or progressed following standard therapy, or that has not responded to standard therapy, or for which there is no standard therapy.
- •ECOG performance status 0-
- •Have measurable or evaluated disease based on RECIST1.
- •as determined by investigator.
- •Adequate Organ Function Laboratory Values
- •Absolute neutrophil count ≥ 1.5 x 109/L, Hemoglobin ≥ 9g/dL, Platelets ≥ 75 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 subjects with liver metastases)
- •creatinine ≤1.5 x UNL
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 tumours 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
Arms & Interventions
sunitinib
sunitinib 50mg will be administered orally once a day 42 days.Study treatment will be continued until objective disease progression.
Intervention: sunitinib
Outcomes
Primary Outcomes
progression-free survival
Time Frame: expected average of 24 weeks
Secondary Outcomes
- objective response rate(expected average of 24 weeks)
- Time to progression(expected average of 24 weeks)
- overall survival(expected average of 24 weeks)
- Number of subjects with Adverse Events as a measure of toxicity profile(expected average of 24 weeks)