Open-Label Surufatinib in European Patients With NET
18 Years and older, Male and Female
2020-012-00EU1 (primary)
NCI-2022-06079
Summary
This is a Phase 2, open-label, multi-centre study of surufatinib in patients with low to
intermediate grade (Grade 1 or Grade 2), well-differentiated neuroendocrine tumours (NETs).
Objectives
This is a Phase 2, open-label, multi-centre study of surufatinib in patients with low- to
intermediate-grade (Grade 1 or Grade 2), well-differentiated NETs.
The study will enroll 4 cohorts of varying NETs, as follows:
- Cohort A - NET of lung origin
- Cohort B - NET of small bowel origin
- Cohort C - NET of non-small bowel, non-pancreas, and non-lung origin
- Cohort D - NET of any origin (DDI substudy)
All patients will be treated with oral surufatinib 300 mg QD in treatment cycles of 28 days
starting on Cycle 1 Day 1.
Eligibility
- Has histologically or cytologically documented, locally advanced, or metastatic NET and has progressed on at least 1 prior line of therapy, but no more than 3 therapies;
- Has radiologic evidence of progressive tumour within 12 months of study enrolment
- Is willing and able to provide informed consent
- Is =18 years of age
- Has measurable lesions according to RECIST Version 1.1
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Female patients of childbearing potential and male patients with partners of childbearing potential agree to use a highly effective form(s) of contraception
Treatment Sites in Georgia
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