NCT04579679

Open-Label Surufatinib in European Patients With NET

An Open-Label Phase 2 Study of Surufatinib in Patients With Neuroendocrine Tumours in Europe

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Hutchmed · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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.

Conditions

• Neuroendocrine Tumours
• Neuroendocrine Tumour of the Lung
• Small Intestinal NET

Interventions

Type	Name	Description
DRUG	Surufatinib	Surufatinib 300 mg oral once daily

Timeline

• Start date: 2021-08-13
• Primary completion: 2024-09-06
• Completion: 2024-10-15
• First posted: 2020-10-08
• Last updated: 2025-07-25
• Results posted: 2025-07-25

Locations

23 sites across 7 countries: United States, France, Germany, Italy, Norway, Spain, United Kingdom

Regulatory

• FDA-regulated drug study