Single-arm Study to Evaluate the Safety and Efficacy of Sunitinib, in Subjects With RET Fusion Po… (NCT02450123) | Clinical Trial Compass
CompletedNot Applicable
Single-arm Study to Evaluate the Safety and Efficacy of Sunitinib, in Subjects With RET Fusion Positive or FGFR2 Amplification, Refractory Solid Tumors
South Korea1 participantsStarted 2016-03-23
Plain-language 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.
Who can participate
Age range20 Years
SexALL
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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 0-2.
✓. Have measurable or evaluated disease based on RECIST1.1. as determined by investigator.
✓. Adequate Organ Function Laboratory Values
✓. Patients of child-bearing potential should be using adequate contraceptive measures (two forms of highly reliable methods) 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 tumours curatively treated with no evidence of disease for ≤5 years.