Chi-Med Initiates Sulfatinib Phase III Registration Study
News Mar 23, 2016
Hutchison China MediTech Limited has announced that Hutchison MediPharma Limited has initiated SANET-p, a Phase III registration trial of sulfatinib (HMPL-012) in China in patients with pancreatic neuroendocrine tumors (“NETs”). The first patient was dosed on March 18, 2016. The protocol for SANET-p is similar to SANET-ep, a Phase III registration trial in patients with extra-pancreatic NETs.
SANET-p is a randomized, double-blind, placebo-controlled, multi-center Phase III sulfatinib registration study to treat patients with low or intermediate grade advanced NET whose disease has progressed, locally advanced or distant metastasized and for whom there is no effective therapy. Patients are randomized at a 2:1 ratio to receive either 300 milligrams of sulfatinib orally once per day, or placebo, on an every 28-day treatment cycle.
The primary objective of this study is to evaluate the progression-free survival of sulfatinib as compared to that of placebo, with secondary endpoints including objective response rate (“ORR”), disease control rate, time to response, duration of response, overall survival, safety and tolerability. Approximately 195 patients are expected to be enrolled in the SANET-p study from more than 20 centers across China, with top-line results expected in 2018.
Additional details about this study may be found at clinicaltrials.gov, using identifier NCT02589821. Sulfatinib is an oral drug candidate that selectively inhibits the tyrosine kinase activity associated with the vascular endothelial growth factor receptor (“VEGFR”) and fibroblast growth receptor (“FGFR”), two tyrosine kinase receptors associated with angiogenesis and tumor growth.
HMP believes that sulfatinib’s VEGFR/FGFR1 inhibition profile has strong potential in second-line thyroid cancer patients, particularly in China where there are few safe and effective treatment options for this patient population. Including this trial, HMP is conducting five Phase II and Phase III clinical trials of sulfatinib in China and the U.S.