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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surufatinib | Drug | HMP-012 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marjo Hahka-Kemppinen, MD | Hutchison Medipharma Limited | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rocky Mountain Cancer Center | Denver | Colorado | 80218 | United States | ||
| Mercy Medical Center, Medical Oncology & Hematology |
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| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000717729 | surufatinib |
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| 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 |
| D009380 | Neoplasms, Nerve Tissue |