Expanded Access Program of Surufatinib

An Expanded Access Program of Surufatinib for Patients With Advanced or Metastatic Neuroendocrine Tumors

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.

Study Overview

• Status: No longer available
• Conditions: Neuroendocrine Tumors
• Intervention / Treatment: Drug: Surufatinib

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 Type: Expanded Access
• Expanded Access Type: Individual Patients; Treatment IND/Protocol

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80218
      • Rocky Mountain Cancer Center
  • Maryland
    • Baltimore, Maryland, United States, 21202
      • Mercy Medical Center, Medical Oncology & Hematology
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Karmanos Cancer Center
  • Missouri
    • Kansas City, Missouri, United States, 64114
      • MidAmerica Cancer Care
  • New Jersey
    • Florham Park, New Jersey, United States, 07932
      • Summit Medical Group
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute
  • Oregon
    • Portland, Oregon, United States, 97213
      • Providence Cancer Institute Franz Clinic, Providence Health & Services
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • Avera Cancer Institute
  • Texas
    • Dallas, Texas, United States, 75246
      • Texas Oncology - Baylor Charles A. Sammons Cancer Center
  • Utah
    • Murray, Utah, United States, 84107
      • Intermountain Healthcare
    • St. George, Utah, United States, 84790
      • Intermountain Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Hutchmed
• Investigators: Study Chair: Marjo Hahka-Kemppinen, MD, Hutchison Medipharma Limited

Study record dates

Study Major Dates

• Study Start: December 7, 2022
• Primary Completion: December 7, 2022
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: March 22, 2021
• First Submitted That Met QC Criteria: March 23, 2021
• First Posted (Actual): March 24, 2021

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; surufatinib
• Other Study ID Numbers: 2020-012-GLOB3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No