Open-Label Surufatinib in European Patients With NET (NCT04579679) | Clinical Trial Compass
TerminatedPhase 2
Open-Label Surufatinib in European Patients With NET
Stopped: Sponsor decision
United States78 participantsStarted 2021-08-13
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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
What they're measuring
1
Disease Control Rate (DCR)
Timeframe: 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
✕. 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.
✕. 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.