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Open-Label Surufatinib in European Patients With NET

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04579679
Recruitment Status : Recruiting
First Posted : October 8, 2020
Last Update Posted : October 6, 2022
Sponsor:
Information provided by (Responsible Party):
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).

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 ...

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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

Drug: Surufatinib
Surufatinib 300 mg oral once daily
Other Name: HMPL-012, sulfatinib




Primary Outcome Measures :
  1. Disease Control Rate (DCR) [ Time Frame: up to 6 months ]
    Disease control rate the incidence of complete response, partial response and stable disease.


Secondary Outcome Measures :
  1. 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

  2. QTc change from Baseline [ Time Frame: up to 6 months ]
    QTc change from baseline in approximately first 40 patients (Cohorts A, B, and C)

  3. Evaluation of safety and tolerability of surufatinib [ Time Frame: Up to 12 months ]
    Evaluate the safety and tolerability of surufatinib in patients with NET

  4. 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).

  5. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

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


Contacts
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Contact: Nick Lawn +44 7826 422448 nickl@hutch-med.com

Locations
Show Show 23 study locations
Sponsors and Collaborators
Hutchmed
Investigators
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Study Director: John Kauh, MD Hutchmed
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Responsible Party: Hutchmed
ClinicalTrials.gov Identifier: NCT04579679    
Other Study ID Numbers: 2020-012-00EU1
First Posted: October 8, 2020    Key Record Dates
Last Update Posted: October 6, 2022
Last Verified: October 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hutchmed:
VEGF
Additional relevant MeSH terms:
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Neoplasms
Neuroendocrine Tumors
Lung Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases