Open-Label Surufatinib in European Patients With NET

Prior treatment

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

Other illness

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