NCT05077384

Open-label Study of Surufatinib in Japanese Patients

An Open-Label Study of Surufatinib in Japanese Patients With Neuroendocrine Tumors

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Hutchmed · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 1/2, open-label, multi-centre study of surufatinib in patients with unresectable, locally advanced, or recurrent nonhematologic malignancies who do not respond or are intolerant to standard of care.

Detailed description

The purpose of this study is to evaluate the tolerability and efficacy of surufatinib in Japanese patients. The study will be conducted in 2 parts: * Part 1 - evaluation of tolerability and safety of surufatinib and confirmation of the recommended clinical dose in Japanese patients with nonhematologic malignancies * Part 2 - evaluation of antitumor activity and confirmation of tolerability of surufatinib in Japanese patients with NETs 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 Tumors
• Non-hematologic Malignancy

Interventions

Type	Name	Description
DRUG	Surufatinib	Surufatinib 300 mg oral once daily

Timeline

• Start date: 2021-09-02
• Primary completion: 2024-09-06
• Completion: 2025-01-17
• First posted: 2021-10-14
• Last updated: 2025-09-16

Locations

12 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study