Hutchison China MediTech Limited has announced that Hutchison MediPharma Limited, its drug R&D subsidiary, has initiated an open-label Phase II clinical trial to evaluate the efficacy and safety of sulfatinib (HMPL-012) in patients with locally advanced or metastatic radioactive iodine-refractory differentiated thyroid cancer (“DTC”) or medullary thyroid cancer (“MTC”) in China. The first patient was dosed on 1 March 2016.
HMP plans to enroll approximately 50 DTC and MTC patients into this study, with approximately 25 patients in each tumor type. The primary objective is to evaluate the objective response rate (“ORR”), while secondary and exploratory objectives include the evaluation of safety and tolerability, other efficacy parameters, pharmacokinetics, and tumor biomarkers.
The study employs a two-stage design in which 15 subjects of each tumor type will be enrolled in the first stage. An additional 10 subjects in each tumor type will be enrolled after efficacy assessment in the second stage. Additional details about this study may be found at clinicaltrials.gov, using identifier NCT02614495.
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.
In addition to the thyroid cancer trial, HMP is conducting or in the process of initiating four clinical trials in neuroendocrine tumors (“NETs”).