Open-Label Surufatinib in European Patients with NET
- Conditions
- Neuroendocrine TumoursNeuroendocrine Tumour of the LungSmall Intestinal NET
- Interventions
- Registration Number
- NCT04579679
- Lead Sponsor
- Hutchmed
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 78
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Surufatinib Surufatinib 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
- Primary Outcome Measures
Name Time Method Disease Control Rate (DCR) up to 6 months Disease control rate the incidence of complete response, partial response and stable disease.
- Secondary Outcome Measures
Name Time Method Evaluation of safety and tolerability of surufatinib Up to 12 months Evaluate the safety and tolerability of surufatinib in patients with NET
Progression Free Survival (PFS) up to 12 months the duration between the enrollment date and the first disease progression (PD) or death (whichever comes first).
QTc change from Baseline up to 6 months QTc change from baseline in approximately first 40 patients (Cohorts A, B, and C)
Maximum plasma concentrations of surufatinib with blood sampling up to 12 months Blood sampling will be taken to measure levels of the study drug in all cohorts and cytochrome P450 in cohort D only
Duration of Response (DOR) up to 12 months 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
Trial Locations
- Locations (23)
Houston Methodist
🇺🇸Hosuton, Texas, United States
CHU Bordeaux
🇫🇷Pessac, France
Institut Gustave Roussy
🇫🇷Villejuif, France
Charite Universitatsmedizin Berlin
🇩🇪Berlin, Germany
Universitaetsklinikum Erlangen
🇩🇪Erlangen, Germany
Universitatsklinikum Essen, Klinik fur Endokrinologie
🇩🇪Essen, Germany
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, Italy
Haukeland University Hospital
🇳🇴Bergen, Norway
Oslo University Hospital Rikshospitalet
🇳🇴Oslo, Norway
Institut Catala d'Oncologis (ICO) - Hospital Duran i Reynals
🇪🇸Barcelona, Spain
Hospital Vall Hebron
🇪🇸Barcelona, Spain
Hospital Universitario Ramon y Cajal
🇪🇸Madrid, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital Universitario Virgen del Rocio
🇪🇸Sevilla, Spain
Sarah Cannon Research Institute
🇬🇧London, United Kingdom
Christie Hospital
🇬🇧Manchester, United Kingdom
University of Alabama, Birmingham (UAB)
🇺🇸Birmingham, Alabama, United States
University of California Irvine Medical Center UCIMC - H.H. Chao Comprehensive Digestive Disease Center CDDC
🇺🇸Orange, California, United States
Emory University, Winship Cancer Institute
🇺🇸Atlanta, Georgia, United States
Stony Brook Cancer Center
🇺🇸Stony Brook, New York, United States