Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2025-12-25 @ 7:34 PM
Study NCT ID:
NCT04814732
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2024-04-12
First Post:
2021-03-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Expanded Access Program of Surufatinib
Sponsor:
Hutchmed
Organization:
Study Overview
Official Title:
An Expanded Access Program of Surufatinib for Patients With Advanced or Metastatic Neuroendocrine Tumors
Status:
NO_LONGER_AVAILABLE
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: