Open-Label Surufatinib in European Patients With NET

NCT ID: NCT04579679

Last Updated: 2025-07-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-13
• Study Completion Date: 2024-10-15

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Surufatinib

Cohorts A, B, and C: oral surufatinib 300 mg once daily in treatment cycles of 28 days starting at Cycle 1 Day1

Cohort D:

Surufatinib 300 mg once daily in treatment cycles of 28 days starting at Cycle 1 Day and single doses of drug cocktail on Day-2 and Day 15 Cycle 1

Group Type: EXPERIMENTAL

Surufatinib

Intervention Type: DRUG

Surufatinib 300 mg oral once daily

Interventions

Surufatinib

Surufatinib 300 mg oral once daily

Intervention Type: DRUG

Other Intervention Names

HMPL-012, sulfatinib

Eligibility Criteria

Inclusion Criteria

1. 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;

2. Has radiologic evidence of progressive tumour within 12 months of study enrolment

3. Is willing and able to provide informed consent

4. Is ≥18 years of age

5. Has measurable lesions according to RECIST Version 1.1

6. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

7. Female patients of childbearing potential and male patients with partners of childbearing potential agree to use a highly effective form(s) of contraception

Exclusion Criteria

1. Has an AE due to previous anti-tumour therapy that has not recovered to ≤CTCAE Grade 1, except alopecia and peripheral neurotoxicity with ≤CTCAE Grade 2 caused by platinum chemotherapy

2. Major surgery within previous 4 weeks or radiation therapy within 2 weeks prior to the start of treatment.

3. Prior VEGF/VEGFR-targeted therapy

4. Uncontrollable hypertension, defined as systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg, despite antihypertensive medication

5. Gastrointestinal disease or condition within 6 months prior to first dose

6. Has a history or presence of a serious haemorrhage (>30 mL within 3 months) or haemoptysis (>5 mL blood within 4 weeks) within 6 months of first dose of study drug.

7. Clinically significant cardiovascular disease.

8. Brain metastases and/or spinal cord compression untreated with surgery and/or radiotherapy, and without clinical imaging evidence of stable disease (SD) for 14 days or longer; patients requiring steroids within 4 weeks prior to start of study treatment will be excluded.

9. A high risk of bleeding at screening due to tumour invasion into major vessels, such as pulmonary artery, the superior vena cava, or the inferior vena cava, as determined by investigators.

10. Has arterial thrombosis or deep venous thrombosis within 6 months prior to first dosing, or thromboembolic events (including stroke and/or transient ischaemic attack) within 12 months.

11. Has a clinically meaningful ongoing infection (eg, requiring intravenous treatment with anti-infective therapy)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hutchmed

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William Schelman, MD, PhD

Role: STUDY_DIRECTOR

Hutchmed

Locations

University of Alabama, Birmingham (UAB)

Birmingham, Alabama, United States

University of California Irvine Medical Center UCIMC - H.H. Chao Comprehensive Digestive Disease Center CDDC

Orange, California, United States

Emory University, Winship Cancer Institute

Atlanta, Georgia, United States

Stony Brook Cancer Center

Stony Brook, New York, United States

Houston Methodist

Houston, Texas, United States

CHU Bordeaux

Pessac, , France

Institut Gustave Roussy

Villejuif, , France

Charite Universitatsmedizin Berlin

Berlin, , Germany

Universitaetsklinikum Erlangen

Erlangen, , Germany

Universitatsklinikum Essen, Klinik fur Endokrinologie

Essen, , Germany

Azienda Universitaria Ospedaliera Consorziale - Policlinico Bari

Bari, , Italy

ASST-Spedali Civili di Brescia

Brescia, , Italy

Universita degli Studi di Firenze - Azienda Ospedaliero Universitaria Careggi (AOUC)

Florence, , Italy

Istituto Europeo di Oncologia

Milan, , Italy

Haukeland University Hospital

Bergen, , Norway

Oslo University Hospital Rikshospitalet

Oslo, , Norway

Institut Catala d'Oncologis (ICO) - Hospital Duran i Reynals

Barcelona, , Spain

Hospital Vall Hebron

Barcelona, , Spain

Hospital Universitario Ramon y Cajal

Madrid, , Spain

Hospital Universitario 12 de Octubre

Madrid, , Spain

Hospital Universitario Virgen del Rocio

Seville, , Spain

Sarah Cannon Research Institute

London, , United Kingdom

Christie Hospital

Manchester, , United Kingdom

Countries

United States; France; Germany; Italy; Norway; Spain; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2020-012-00EU1

Identifier Type: -

Identifier Source: org_study_id