Open-Label Surufatinib in European Patients With NET

NCT04579679 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: 2020-012-00EU1
• Study Type: interventional
• Target: 78
• Locations: 7 countries
• Sites: 23

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).

Conditions

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

Keywords

VEGF

Outcome Measures

Primary Outcomes (1)

• Disease Control Rate (DCR)

  The DCR was defined as the percentage of patients who achieved a best overall response (BOR) of complete response (CR), partial response (PR) or stable disease (SD) as determined by the Investigator using Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1. The CR was defined as disappearance of all target lesions. The PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum on study.

  RECIST assessments performed at screening (within 28 days before start of study drug), every 8 weeks for the first 24 weeks from C1D1, then every 12 weeks thereafter until the occurrence of disease progression, up to approximately 36 months

Secondary Outcomes (8)

• Plasma Concentrations of Surufatinib

  Cohorts A, B and C: Pre-dose and 1, 2, 3, 4 hours post-dose on Cycle 1 Day 15; Cohort D: Pre-dose and 30 minutes, 1, 2, 3, 4, 5, 6, 8 and 10 hours post-dose on Cycle 1 Day 15

• Number of Patients With Potentially Clinically Significant Corrected QT Interval (QTc) During Treatment

  From the first dose of study drug (Day 1) up to 30 days after last dose of study drug, approximately 33 months

• Objective Response Rate (ORR)

  RECIST assessments performed at screening (within 28 days before start of study drug), every 8 weeks for the first 24 weeks from C1D1, then every 12 weeks thereafter until the occurrence of disease progression, up to approximately 36 months

• Time to Response (TTR)

  RECIST assessments performed at screening (within 28 days before start of study drug), every 8 weeks for the first 24 weeks from C1D1, then every 12 weeks thereafter until the occurrence of disease progression, up to approximately 36 months

• Duration of Response (DOR)

  RECIST assessments performed at screening (within 28 days before start of study drug), every 8 weeks for the first 24 weeks from C1D1, then every 12 weeks thereafter until the occurrence of disease progression, up to approximately 36 months

Study Arms (1)

Surufatinib

EXPERIMENTAL

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

Drug: Surufatinib

Interventions

Surufatinib DRUG

Surufatinib 300 mg oral once daily

Also known as: HMPL-012, sulfatinib

Surufatinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Major surgery within previous 4 weeks or radiation therapy within 2 weeks prior to the start of treatment.
• Prior VEGF/VEGFR-targeted therapy
• Uncontrollable hypertension, defined as systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg, despite antihypertensive medication
• Gastrointestinal disease or condition within 6 months prior to first dose
• 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.
• Clinically significant cardiovascular disease.
• 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.
• 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.
• 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.
• Has a clinically meaningful ongoing infection (eg, requiring intravenous treatment with anti-infective therapy)

Sponsors & Collaborators

• Hutchmed: lead

Study Sites (23)

University of Alabama, Birmingham (UAB)

Birmingham, Alabama, 35233, United States

Location

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

Orange, California, 92868, United States

Location

Emory University, Winship Cancer Institute

Atlanta, Georgia, 30322-1013, United States

Location

Stony Brook Cancer Center

Stony Brook, New York, 11794, United States

Location

Houston Methodist

Houston, Texas, 77030, United States

Location

CHU Bordeaux

Pessac, 33604, France

Location

Institut Gustave Roussy

Villejuif, 94800, France

Location

Charite Universitatsmedizin Berlin

Berlin, 13353, Germany

Location

Universitaetsklinikum Erlangen

Erlangen, 91054, Germany

Location

Universitatsklinikum Essen, Klinik fur Endokrinologie

Essen, 45147, Germany

Location

Azienda Universitaria Ospedaliera Consorziale - Policlinico Bari

Bari, 70124, Italy

Location

ASST-Spedali Civili di Brescia

Brescia, 25123, Italy

Location

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

Florence, 50134, Italy

Location

Istituto Europeo di Oncologia

Milan, 20141, Italy

Location

Haukeland University Hospital

Bergen, 5021, Norway

Location

Oslo University Hospital Rikshospitalet

Oslo, 0372, Norway

Location

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

Barcelona, 8013, Spain

Location

Hospital Vall Hebron

Barcelona, 8035, Spain

Location

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

Location

Sarah Cannon Research Institute

London, W1G 6AD, United Kingdom

Location

Christie Hospital

Manchester, M20 4BX, United Kingdom

Location

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

surufatinib

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Limitations and Caveats

Based upon the strategic reevaluation of the clinical development program for surufatinib in Europe and the United States (US), the study was terminated. The termination was not based on any concern for patient safety or efficacy relative to surufatinib treatment.

Results Point of Contact

• Title: Nick Lawn
• Organization: HUTCHMED International Corporation

nickl@hutch-med.com

+44 7826 422448

Study Officials

• William Schelman, MD, PhD

  Hutchmed

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2020
• First Posted: October 8, 2020
• Study Start: August 13, 2021
• Primary Completion: September 6, 2024
• Study Completion: October 15, 2024
• Last Updated: July 25, 2025
• Results First Posted: July 25, 2025

Record last verified: 2025-07

Locations

FR (2); IT (4); NO (2); DE (3); GB (2); US (5); ES (5)