Open-Label Surufatinib in European Patients With NET
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).
Checked against the public recordLast updated Jul 25, 2025 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Hutchmed
- Interventions being studied
- Drug: Surufatinib
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Key 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 Key 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)
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of Alabama, Birmingham (UAB)Birmingham, Alabama
- University of California Irvine Medical Center UCIMC - H.H. Chao Comprehensive Digestive Disease Center CDDCOrange, California
- Emory University, Winship Cancer InstituteAtlanta, Georgia
- Stony Brook Cancer CenterStony Brook, New York
- Houston MethodistHouston, Texas
- CHU BordeauxPessac
- Institut Gustave RoussyVillejuif
- Charite Universitatsmedizin BerlinBerlin
- Universitaetsklinikum ErlangenErlangen
- Universitatsklinikum Essen, Klinik fur EndokrinologieEssen
- Azienda Universitaria Ospedaliera Consorziale - Policlinico BariBari
- ASST-Spedali Civili di BresciaBrescia
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 25, 2025. Always confirm current availability with the study team.