Clincosm LogoSign in Get a demo

Open-Label Surufatinib in European Patients With NET

Sponsor
Hutchison Medipharma Limited (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04579679
Collaborator
(none)
76
Enrollment
19
Locations
1
Arm
37.1
Anticipated Duration (Months)
4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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).

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated 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 :
Aug 13, 2021
Anticipated Primary Completion Date :
Sep 15, 2023
Anticipated Study Completion Date :
Sep 15, 2024

Arms and Interventions

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 Names:
  • HMPL-012, sulfatinib

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Disease Control Rate (DCR) [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 [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 [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 [Up to 12 months]

      Evaluate the safety and tolerability of surufatinib in patients with NET

    4. 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).

    5. 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

    Eligibility Criteria

    Criteria

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Emory University, Winship Cancer Institute Atlanta Georgia United States 30322-1013
    2 CHU Bordeaux Pessac France 33604
    3 Institut Gustave Roussy Villejuif France 94800
    4 Charite Universitatsmedizin Berlin Berlin Germany 13353
    5 Universitaetsklinikum Erlangen Erlangen Germany 91054
    6 Universitatsklinikum Essen, Klinik fur Endokrinologie Essen Germany 45147
    7 Azienda Universitaria Ospedaliera Consorziale - Policlinico Bari Bari Italy 70124
    8 ASST-Spedali Civili di Brescia Brescia Italy 25123
    9 Universita degli Studi di Firenze - Azienda Ospedaliero Universitaria Careggi (AOUC) Firenze Italy 50134
    10 Istituto Europeo di Oncologia Milano Italy 20141
    11 Haukeland University Hospital Bergen Norway 5021
    12 Oslo University Hospital Rikshospitalet Oslo Norway 0372
    13 Institut Catala d'Oncologis (ICO) - Hospital Duran i Reynals Barcelona Spain 8013
    14 Hospital Vall Hebron Barcelona Spain 8035
    15 Hospital Universitario Ramon y Cajal Madrid Spain 28034
    16 Hospital Universitario 12 de Octubre Madrid Spain 28041
    17 Hospital Universitario Virgen del Rocio Sevilla Spain 41013
    18 Sarah Cannon Research Institute London United Kingdom W1G 6AD
    19 Christie Hospital Manchester United Kingdom M20 4BX

    Sponsors and Collaborators

    • Hutchison Medipharma Limited

    Investigators

    • Study Director: John Kauh, MD, HUTCHMED

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hutchison Medipharma Limited
    ClinicalTrials.gov Identifier:
    NCT04579679
    Other Study ID Numbers:
    • 2020-012-00EU1
    First Posted:
    Oct 8, 2020
    Last Update Posted:
    Mar 11, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hutchison Medipharma Limited
    VEGF
    Additional relevant MeSH terms:
    Neoplasms
    Neuroendocrine Tumors
    Lung Neoplasms

    Study Results

    No Results Posted as of Mar 11, 2022