Trial Profile
A Randomized, Double-blind, Multi-center Phase III Clinical Study to Assess the Efficacy and Safety of Surufatinib Compared to Placebo in Patients With Advanced Pancreatic Neuroendocrine Tumors
Status:
Discontinued
Phase of Trial:
Phase III
Latest Information Update: 03 Apr 2023
Price :
$35
*
At a glance
- Drugs Surufatinib (Primary)
- Indications Neuroendocrine tumours; Pancreatic cancer
- Focus Registrational; Therapeutic Use
- Acronyms SANET-p
- Sponsors Hutchison MediPharma; HUTCHMED
- 13 Sep 2022 Results from NCT02267967, NCT02588170, NCT02589821; assessing whether radiomics-based machine learning model could predict treatment responses in patients with advanced NET, presented at the 47th European Society for Medical Oncology Congress
- 07 Jun 2022 Results of pooled analysis of two studies ( SANET-p and SANET-ep) assessing surufatinib safety , presented at the 58th Annual Meeting of the American Society of Clinical Oncology.
- 02 May 2022 According to a HUTCHMED media release, U.S. Food and Drug Administration has issued a Complete Response Letter regarding the New Drug Application for surufatinib for the treatment of pancreatic and extra-pancreatic neuroendocrine tumors. FDA determined that the current data package, based on two positive Phase III trials in China and one bridging study in the United States (U.S.), does not support an approval in the U.S. at this time.