Expanded Access Program of Surufatinib
An Expanded Access Program of Surufatinib for Patients With Advanced or Metastatic Neuroendocrine Tumors
1 other identifier
expanded_access
N/A
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 22, 2021
CompletedFirst Posted
Study publicly available on registry
March 24, 2021
CompletedApril 12, 2024
April 1, 2024
March 22, 2021
April 11, 2024
Conditions
Interventions
HMP-012
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hutchmedlead
Study Sites (11)
Rocky Mountain Cancer Center
Denver, Colorado, 80218, United States
Mercy Medical Center, Medical Oncology & Hematology
Baltimore, Maryland, 21202, United States
Karmanos Cancer Center
Detroit, Michigan, 48201, United States
MidAmerica Cancer Care
Kansas City, Missouri, 64114, United States
Summit Medical Group
Florham Park, New Jersey, 07932, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Providence Cancer Institute Franz Clinic, Providence Health & Services
Portland, Oregon, 97213, United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57105, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246, United States
Intermountain Healthcare
Murray, Utah, 84107, United States
Intermountain Cancer Center
St. George, Utah, 84790, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Marjo Hahka-Kemppinen, MD
Hutchison Medipharma Limited
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2021
First Posted
March 24, 2021
Last Updated
April 12, 2024
Record last verified: 2024-04