Clinical trial NCT04579679: Open-Label Surufatinib in European Patients With NET
Official title: An Open-Label Phase 2 Study of Surufatinib in Patients With Neuroendocrine Tumours in Europe
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neuroendocrine Tumours
Neuroendocrine Tumour of the Lung
Small Intestinal NET
Keywords: VEGF
Lead sponsor: Hutchmed
Sponsor class: INDUSTRY
First posted: 2020-10-08
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).

Detailed description: 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 NETs.

The study will enroll 4 cohorts of varying NETs, as follows:

* Cohort A - NET of lung origin
* Cohort B - NET of small bowel origin
* Cohort C - NET of non-small bowel, non-pancreas, and non-lung origin
* Cohort D - NET of any origin (DDI substudy)

All patients will be treated with oral surufatinib 300 mg QD in treatment cycles of 28 days starting on Cycle 1 Day 1.

Eligibility criteria: 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)

Primary outcomes:
measure: Disease Control Rate (DCR)
timeFrame: up to 6 months
Secondary outcomes:
measure: Maximum plasma concentrations of surufatinib with blood sampling
timeFrame: up to 12 months
measure: QTc change from Baseline
timeFrame: up to 6 months
measure: Evaluation of safety and tolerability of surufatinib
timeFrame: Up to 12 months
measure: Progression Free Survival (PFS)
timeFrame: up to 12 months
measure: Duration of Response (DOR)
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama, Birmingham (UAB)
state: Alabama
city: Orange
country: United States
facility: University of California Irvine Medical Center UCIMC - H.H. Chao Comprehensive Digestive Disease Center CDDC
state: California
city: Atlanta
country: United States
facility: Emory University, Winship Cancer Institute
state: Georgia
city: Stony Brook
country: United States
facility: Stony Brook Cancer Center
state: New York
city: Hosuton
country: United States
facility: Houston Methodist
state: Texas
city: Pessac
country: France
facility: CHU Bordeaux
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Berlin
country: Germany
facility: Charite Universitatsmedizin Berlin
city: Erlangen
country: Germany
facility: Universitaetsklinikum Erlangen
city: Essen
country: Germany
facility: Universitatsklinikum Essen, Klinik fur Endokrinologie
city: Bari
country: Italy
facility: Azienda Universitaria Ospedaliera Consorziale - Policlinico Bari
city: Brescia
country: Italy
facility: ASST-Spedali Civili di Brescia
city: Firenze
country: Italy
facility: Universita degli Studi di Firenze - Azienda Ospedaliero Universitaria Careggi (AOUC)
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Oslo
country: Norway
facility: Oslo University Hospital Rikshospitalet
city: Barcelona
country: Spain
facility: Institut Catala d'Oncologis (ICO) - Hospital Duran i Reynals
city: Barcelona
country: Spain
facility: Hospital Vall Hebron
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: London
country: United Kingdom
facility: Sarah Cannon Research Institute
city: Manchester
country: United Kingdom
facility: Christie Hospital
Study officials:
affiliation: Hutchmed
name: John Kauh, MD
role: STUDY_DIRECTOR
References: