Open-Label Surufatinib in European Patients With NET
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|ClinicalTrials.gov Identifier: NCT04579679|
Recruitment Status : Recruiting
First Posted : October 8, 2020
Last Update Posted : October 6, 2022
|Condition or disease||Intervention/treatment||Phase|
|Neuroendocrine Tumours Neuroendocrine Tumour of the Lung Small Intestinal NET||Drug: Surufatinib||Phase 2|
Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial. More info ...
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||76 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Phase 2 Study of Surufatinib in Patients With Neuroendocrine Tumours in Europe|
|Actual Study Start Date :||August 13, 2021|
|Estimated Primary Completion Date :||September 15, 2023|
|Estimated Study Completion Date :||September 15, 2024|
Cohorts A, B, and C: oral surufatinib 300 mg once daily in treatment cycles of 28 days starting at Cycle 1 Day1
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
Surufatinib 300 mg oral once daily
Other Name: HMPL-012, sulfatinib
- Disease Control Rate (DCR) [ Time Frame: up to 6 months ]Disease control rate the incidence of complete response, partial response and stable disease.
- Maximum plasma concentrations of surufatinib with blood sampling [ Time Frame: 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
- QTc change from Baseline [ Time Frame: up to 6 months ]QTc change from baseline in approximately first 40 patients (Cohorts A, B, and C)
- Evaluation of safety and tolerability of surufatinib [ Time Frame: Up to 12 months ]Evaluate the safety and tolerability of surufatinib in patients with NET
- Progression Free Survival (PFS) [ Time Frame: up to 12 months ]the duration between the enrollment date and the first disease progression (PD) or death (whichever comes first).
- Duration of Response (DOR) [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04579679
|Contact: Nick Lawn||+44 7826 firstname.lastname@example.org|
|Study Director:||John Kauh, MD||Hutchmed|