Open-label Study of Surufatinib in Japanese Patients

Korábbi kezelés

• 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
• 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 prior to first dosing.

Más betegség

• Has a history of interstitial lung disease (ILD)/noninfectious pneumonitis, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
• 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)
• 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.

Egyéb

• Women who are pregnant and lactating, or possibly pregnant.
• Known active viral hepatits

• Histologically or cytologically documented disease as follows:
  • Part 1: unresectable, locally advanced or metastatic nonhematologic malignancy that is relapsed/refractory to or intolerant of established therapies known to provide clinical benefit
  • Part 2: locally advanced or metastatic, low (grade 1) or intermediate (grade 2) grade NETs that have been previously treated with at least 1 line of systemic therapy
• Has radiologic evidence of progressive tumour within 12 months of study enrolment
• Is willing and able to provide informed consent
• Is ≥20 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