Open-Label Surufatinib in European Patients With NET

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)