NCT04814732

Expanded Access Program of Surufatinib

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

• Status: No Longer Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Hutchmed · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: —

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.

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.

Conditions

• Neuroendocrine Tumors

Interventions

Type	Name	Description
DRUG	Surufatinib	HMP-012

Timeline

• First posted: 2021-03-24
• Last updated: 2024-04-12

Locations

11 sites across 1 country: United States