Expanded Access Program of Surufatinib

NO_LONGER_AVAILABLE

Conditions studied: Neuroendocrine Tumors

In brief

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.

Key facts

Study ID

NCT04814732

Run by

Hutchmed

Last updated by the study team

2024-04-12

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically documented, well differentiated, locally advanced or metastatic NETs
• 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
• ≥12 years of age
• In the opinion of the patient's treating physician, other treatment options or clinical trials in this indication are unsuitable
• Patient has adequate bone marrow and organ function
• Urine dipstick ≤1+ for proteinuria or ≤30 mg/dL in urinalysis,
• 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
• 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

You may not qualify if…

• Uncontrollable hypertension, as defined by local institution
• Gastrointestinal disease or condition that the physician suspects may affect drug absorption
• History or presence of a serious hemorrhage
• Clinically significant cardiovascular disease
• Brain metastases and/or spinal cord compression untreated with surgery and/or radiotherapy
• High risk of bleeding at screening due to tumor invasion
• 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
• Received treatment with anticancer therapy, including investigational therapy, within 7 days or 5 half-lives (whichever is longer)
• Received prior treatment with surufatinib
• Inability to take medication orally
• Any other clinically significant comorbidities that, in the judgment of the treating physician, could predispose the patient to safety risks

Where it is running

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

Full record on ClinicalTrials.gov

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