Expanded Access Program of Surufatinib

• ClinicalTrials.gov Identifier: NCT04814732
• Expanded Access Status: No longer available
• First Posted: March 24, 2021
• Last Update Posted: October 31, 2022
• Sponsor: Hutchmed
• Information provided by (Responsible Party): Hutchmed

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
Neuroendocrine Tumors	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 Design

• Study Type: Expanded Access
• Expanded Access Type: Individual Patients, Treatment IND/Protocol

See clinical trials of the intervention/treatment in this expanded access record.

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

Interventions

Intervention Details:

• Drug: Surufatinib
  HMP-012

Eligibility Criteria

• Ages Eligible for Study: 12 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All

Criteria

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

United States, Colorado

Rocky Mountain Cancer Center

Denver, Colorado, United States, 80218

United States, Maryland

Mercy Medical Center, Medical Oncology & Hematology

Baltimore, Maryland, United States, 21202

United States, Michigan

Karmanos Cancer Center

Detroit, Michigan, United States, 48201

United States, Missouri

MidAmerica Cancer Care

Kansas City, Missouri, United States, 64114

United States, New Jersey

Summit Medical Group

Florham Park, New Jersey, United States, 07932

United States, New York

Roswell Park Cancer Institute

Buffalo, New York, United States, 14263

United States, Oregon

Providence Cancer Institute Franz Clinic, Providence Health & Services

Portland, Oregon, United States, 97213

United States, South Dakota

Avera Cancer Institute

Sioux Falls, South Dakota, United States, 57105

United States, Texas

Texas Oncology - Baylor Charles A. Sammons Cancer Center

Dallas, Texas, United States, 75246

United States, Utah

Intermountain Healthcare

Murray, Utah, United States, 84107

Intermountain Cancer Center

Saint George, Utah, United States, 84790

Sponsors and Collaborators

Hutchmed

Investigators

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

More Information

• Responsible Party: Hutchmed
• ClinicalTrials.gov Identifier: NCT04814732
• Other Study ID Numbers: 2020-012-GLOB3
• First Posted: March 24, 2021
• Last Update Posted: October 31, 2022
• Last Verified: October 2022

Additional relevant MeSH terms:

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue