Open-Label Surufatinib in European Patients With NET

Neuroendocrine Tumours Clinical Trial

Official title:

An Open-Label Phase 2 Study of Surufatinib in Patients With Neuroendocrine Tumours in Europe

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04579679
• Other study ID #: 2020-012-00EU1
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: August 13, 2021
• Est. completion date: September 15, 2024

Study information

• Verified date: February 2024
• Source: Hutchmed
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 78
• Est. completion date: September 15, 2024
• Est. primary completion date: September 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Lung Neoplasms
• Neoplasms
• Neuroendocrine Tumors
• Neuroendocrine Tumour of the Lung
• Neuroendocrine Tumours
• Small Intestinal NET

Intervention

Drug:
• Surufatinib
Surufatinib 300 mg oral once daily

Locations

Country	Name	City	State
France	CHU Bordeaux	Pessac
France	Institut Gustave Roussy	Villejuif
Germany	Charite Universitatsmedizin Berlin	Berlin
Germany	Universitaetsklinikum Erlangen	Erlangen
Germany	Universitatsklinikum Essen, Klinik fur Endokrinologie	Essen
Italy	Azienda Universitaria Ospedaliera Consorziale - Policlinico Bari	Bari
Italy	ASST-Spedali Civili di Brescia	Brescia
Italy	Universita degli Studi di Firenze - Azienda Ospedaliero Universitaria Careggi (AOUC)	Firenze
Italy	Istituto Europeo di Oncologia	Milano
Norway	Haukeland University Hospital	Bergen
Norway	Oslo University Hospital Rikshospitalet	Oslo
Spain	Hospital Vall Hebron	Barcelona
Spain	Institut Catala d'Oncologis (ICO) - Hospital Duran i Reynals	Barcelona
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario Ramon y Cajal	Madrid
Spain	Hospital Universitario Virgen del Rocio	Sevilla
United Kingdom	Sarah Cannon Research Institute	London
United Kingdom	Christie Hospital	Manchester
United States	Emory University, Winship Cancer Institute	Atlanta	Georgia
United States	University of Alabama, Birmingham (UAB)	Birmingham	Alabama
United States	Houston Methodist	Houston	Texas
United States	University of California Irvine Medical Center UCIMC - H.H. Chao Comprehensive Digestive Disease Center CDDC	Orange	California
United States	Stony Brook Cancer Center	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hutchmed

Countries where clinical trial is conducted

United States,  France,  Germany,  Italy,  Norway,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Control Rate (DCR)	Disease control rate the incidence of complete response, partial response and stable disease.	up to 6 months
Secondary	Maximum plasma concentrations of surufatinib with blood sampling	Blood sampling will be taken to measure levels of the study drug in all cohorts and cytochrome P450 in cohort D only	up to 12 months
Secondary	QTc change from Baseline	QTc change from baseline in approximately first 40 patients (Cohorts A, B, and C)	up to 6 months
Secondary	Evaluation of safety and tolerability of surufatinib	Evaluate the safety and tolerability of surufatinib in patients with NET	Up to 12 months
Secondary	Progression Free Survival (PFS)	the duration between the enrollment date and the first disease progression (PD) or death (whichever comes first).	up to 12 months
Secondary	Duration of Response (DOR)	The duration between the date the criteria for complete response or partial response was first measured (first record shall prevail) and the date of disease recurrence or progression as objectively recorded	up to 12 months