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Expanded Access Program of Surufatinib

Sponsor
Hutchison Medipharma Limited (Industry)
Overall Status
Available
CT.gov ID
NCT04814732
Collaborator
(none)
11
Locations

Study Details

Study Description

Brief Summary

This treatment protocol is intended to provide early access of surufatinib to patients with locally advanced or metastatic NETs for whom, in the opinion of their treating physician, other treatment options or surufatinib clinical trials in this indication are unsuitable. This EAP is currently available in the US only.

Condition or Disease Intervention/Treatment Phase

Detailed Description

Prior to any assessments, all subjects must provide a signed ICF. Prior to inclusion in the program, the patients must undergo all appropriate screening procedures to check for eligibility.

Once eligibility is confirmed, patients will receive treatment with surufatinib 300mg, orally (PO), daily (QD). All patients will undergo continuous monitoring for safety until the end of treatment.

There is no pre-defined duration of treatment for each patient. Patients will be treated until progressive disease (as defined by treating physician), unacceptable toxicity, death, withdrawal from program, the treatment becomes commercially available, or halting of product development.

A follow-up clinic visit is recommended for all patients approximately 30 days after last dose of treatment to complete the final safety assessments, as applicable.

Study Design

Study Type:
Expanded Access
Official Title:
An Expanded Access Program of Surufatinib for Patients With Advanced or Metastatic Neuroendocrine Tumors

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    1. Histologically or cytologically documented, well differentiated, locally advanced or metastatic NETs

    2. The patient or parent/legal guardian (as appropriate) is willing and able to provide informed consent, and where required, the patient is willing to provide assent

    3. ≥12 years of age

    4. In the opinion of the patient's treating physician, other treatment options or clinical trials in this indication are unsuitable

    5. Patient has adequate bone marrow and organ function

    6. Urine dipstick ≤1+ for proteinuria or ≤30 mg/dL in urinalysis,

    7. ECOG ≤2 for adult patients (≥18 years of age), Karnofsky ≥60 for patients >16 and <18 years of age, and Lansky ≥60 for pediatric patients ≤16 years of age

    8. For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and partner) to use a highly effective form(s) of contraception

    Exclusion Criteria:

    1. Uncontrollable hypertension, as defined by local institution

    2. Gastrointestinal disease or condition that the physician suspects may affect drug absorption

    3. History or presence of a serious hemorrhage

    4. Clinically significant cardiovascular disease

    5. Brain metastases and/or spinal cord compression untreated with surgery and/or radiotherapy

    6. High risk of bleeding at screening due to tumor invasion

    7. Arterial thrombosis or deep venous thrombosis within 6 months prior to first dosing or thromboembolic events (including stroke and/or transient ischemic attack) within 6 months prior to first dosing

    8. Received treatment with anticancer therapy, including investigational therapy, within 7 days or 5 half-lives (whichever is longer)

    9. Received prior treatment with surufatinib

    10. Inability to take medication orally

    11. Any other clinically significant comorbidities that, in the judgment of the treating physician, could predispose the patient to safety risks

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rocky Mountain Cancer Center Denver Colorado United States 80218
    2 Mercy Medical Center, Medical Oncology & Hematology Baltimore Maryland United States 21202
    3 Karmanos Cancer Center Detroit Michigan United States 48201
    4 MidAmerica Cancer Care Kansas City Missouri United States 64114
    5 Summit Medical Group Florham Park New Jersey United States 07932
    6 Roswell Park Cancer Institute Buffalo New York United States 14263
    7 Providence Cancer Institute Franz Clinic, Providence Health & Services Portland Oregon United States 97213
    8 Avera Cancer Institute Sioux Falls South Dakota United States 57105
    9 Texas Oncology - Baylor Charles A. Sammons Cancer Center Dallas Texas United States 75246
    10 Intermountain Healthcare Murray Utah United States 84107
    11 Intermountain Cancer Center Saint George Utah United States 84790

    Sponsors and Collaborators

    • Hutchison Medipharma Limited

    Investigators

    • Study Chair: John Kauh, MD, Hutchison Medipharma Limited

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hutchison Medipharma Limited
    ClinicalTrials.gov Identifier:
    NCT04814732
    Other Study ID Numbers:
    • 2020-012-GLOB3
    First Posted:
    Mar 24, 2021
    Last Update Posted:
    Apr 13, 2022
    Last Verified:
    Apr 1, 2022
    Additional relevant MeSH terms:
    Neuroendocrine Tumors

    Study Results

    No Results Posted as of Apr 13, 2022