Back to resultsOpen-Label Surufatinib in European Patients With NET
Primary Purpose
Neuroendocrine Tumours, Neuroendocrine Tumour of the Lung, Small Intestinal NET
Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Surufatinib
Sponsored by
About this trial
This is an interventional treatment trial for Neuroendocrine Tumours focused on measuring VEGF
Eligibility Criteria
Key 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
Key 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
- 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.
- Clinically significant cardiovascular disease.
- 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.
- 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.
- 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.
- Has a clinically meaningful ongoing infection (eg, requiring intravenous treatment with anti-infective therapy)
Sites / Locations
- University of Alabama, Birmingham (UAB)
- University of California Irvine Medical Center UCIMC - H.H. Chao Comprehensive Digestive Disease Center CDDC
- Emory University, Winship Cancer Institute
- Stony Brook Cancer Center
- Houston Methodist
- CHU Bordeaux
- Institut Gustave Roussy
- Charite Universitatsmedizin Berlin
- Universitaetsklinikum Erlangen
- Universitatsklinikum Essen, Klinik fur Endokrinologie
- Azienda Universitaria Ospedaliera Consorziale - Policlinico Bari
- ASST-Spedali Civili di Brescia
- Universita degli Studi di Firenze - Azienda Ospedaliero Universitaria Careggi (AOUC)
- Istituto Europeo di Oncologia
- Haukeland University Hospital
- Oslo University Hospital Rikshospitalet
- Institut Catala d'Oncologis (ICO) - Hospital Duran i Reynals
- Hospital Vall Hebron
- Hospital Universitario Ramon y Cajal
- Hospital Universitario 12 de Octubre
- Hospital Universitario Virgen del Rocio
- Sarah Cannon Research Institute
- Christie Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Surufatinib
Arm Description
Cohorts A, B, and C: oral surufatinib 300 mg once daily in treatment cycles of 28 days starting at Cycle 1 Day1 Cohort D: Surufatinib 300 mg once daily in treatment cycles of 28 days starting at Cycle 1 Day and single doses of drug cocktail on Day-2 and Day 15 Cycle 1
Outcomes
Primary Outcome Measures
Disease Control Rate (DCR)
Disease control rate the incidence of complete response, partial response and stable disease.
Secondary Outcome Measures
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
QTc change from Baseline
QTc change from baseline in approximately first 40 patients (Cohorts A, B, and C)
Evaluation of safety and tolerability of surufatinib
Evaluate the safety and tolerability of surufatinib in patients with NET
Progression Free Survival (PFS)
the duration between the enrollment date and the first disease progression (PD) or death (whichever comes first).
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04579679
Brief Title
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
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 13, 2021 (Actual)
Primary Completion Date
September 15, 2023 (Anticipated)
Study Completion Date
September 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hutchmed
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroendocrine Tumours, Neuroendocrine Tumour of the Lung, Small Intestinal NET
Keywords
VEGF
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
78 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Surufatinib
Arm Type
Experimental
Arm Description
Cohorts A, B, and C: oral surufatinib 300 mg once daily in treatment cycles of 28 days starting at Cycle 1 Day1
Cohort D:
Surufatinib 300 mg once daily in treatment cycles of 28 days starting at Cycle 1 Day and single doses of drug cocktail on Day-2 and Day 15 Cycle 1
Intervention Type
Drug
Intervention Name(s)
Surufatinib
Other Intervention Name(s)
HMPL-012, sulfatinib
Intervention Description
Surufatinib 300 mg oral once daily
Primary Outcome Measure Information:
Title
Disease Control Rate (DCR)
Description
Disease control rate the incidence of complete response, partial response and stable disease.
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
Maximum plasma concentrations of surufatinib with blood sampling
Description
Blood sampling will be taken to measure levels of the study drug in all cohorts and cytochrome P450 in cohort D only
Time Frame
up to 12 months
Title
QTc change from Baseline
Description
QTc change from baseline in approximately first 40 patients (Cohorts A, B, and C)
Time Frame
up to 6 months
Title
Evaluation of safety and tolerability of surufatinib
Description
Evaluate the safety and tolerability of surufatinib in patients with NET
Time Frame
Up to 12 months
Title
Progression Free Survival (PFS)
Description
the duration between the enrollment date and the first disease progression (PD) or death (whichever comes first).
Time Frame
up to 12 months
Title
Duration of Response (DOR)
Description
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
Time Frame
up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key 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
Key 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
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.
Clinically significant cardiovascular disease.
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.
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.
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.
Has a clinically meaningful ongoing infection (eg, requiring intravenous treatment with anti-infective therapy)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Kauh, MD
Organizational Affiliation
Hutchmed
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama, Birmingham (UAB)
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
University of California Irvine Medical Center UCIMC - H.H. Chao Comprehensive Digestive Disease Center CDDC
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Emory University, Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322-1013
Country
United States
Facility Name
Stony Brook Cancer Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Houston Methodist
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
CHU Bordeaux
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94800
Country
France
Facility Name
Charite Universitatsmedizin Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Universitaetsklinikum Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Universitatsklinikum Essen, Klinik fur Endokrinologie
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Azienda Universitaria Ospedaliera Consorziale - Policlinico Bari
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
ASST-Spedali Civili di Brescia
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Universita degli Studi di Firenze - Azienda Ospedaliero Universitaria Careggi (AOUC)
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Istituto Europeo di Oncologia
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Haukeland University Hospital
City
Bergen
ZIP/Postal Code
5021
Country
Norway
Facility Name
Oslo University Hospital Rikshospitalet
City
Oslo
ZIP/Postal Code
0372
Country
Norway
Facility Name
Institut Catala d'Oncologis (ICO) - Hospital Duran i Reynals
City
Barcelona
ZIP/Postal Code
8013
Country
Spain
Facility Name
Hospital Vall Hebron
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Sarah Cannon Research Institute
City
London
ZIP/Postal Code
W1G 6AD
Country
United Kingdom
Facility Name
Christie Hospital
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Open-Label Surufatinib in European Patients With NET
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