- Cancer Biology & Biomarkers
- Chromatography & Mass Spectrometry
- Contract Research, Clinical Trials and Outsourcing
- Drug Discovery
- Drug Targets
- Flow Cytometry
- Informatics & Lab Automation
- Ingredients, Excipients and Dosages
- Microbiology & RMMs
- NIR, PAT & QbD
- Raman Spectroscopy
- Screening, Assays & High-Content Analysis
- Thermal Processing
- Events & Workshops
Phase II trial of sulfatinib in thyroid cancer starts
2 March 2016 • Author: Victoria White, Digital Content Producer
Chi-Med’s drug R&D subsidiary, MediPharma Limited (HMP), has initiated an open-label Phase II clinical trial to evaluate the efficacy and safety of sulfatinib (HMPL-012) in patients with thyroid cancer.
Specifically, the trial will evaluate sulfatinib in 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 tumour 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 tumour biomarkers. The study employs a two-stage design in which 15 subjects of each tumour type will be enrolled in the first stage. An additional 10 subjects in each tumour type will be enrolled after efficacy assessment in the second stage.
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 tumour 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 tumours (NETs).
Chi-Med is a China-based globally-focused healthcare group which researches, develops, manufactures and sells pharmaceuticals and health-related consumer products.
ABB Analytical Measurement ACD/Labs ADInstruments Ltd Advanced Analytical Technologies GmbH Analytik Jena AG Astell Scientific Ltd Bachem AG Bibby Scientific Limited Bio-Rad Laboratories BioNavis Ltd Biopharma Group Black Swan Analysis Limited Charles Ischi AG | Kraemer Elektronik Cherwell Laboratories CI Precision Cobalt Light Systems Coulter Partners CPC Biotech srl Dassault Systèmes BIOVIA DiscoverX Edinburgh Instruments Enterprise System Partners (ESP) EUROGENTEC F.P.S. Food and Pharma Systems Srl IDBS JEOL Europe L.B. Bohle Maschinen + Verfahren GmbH Lab M Ltd. LabWare Linkam Scientific Instruments Limited Molins Technologies Multicore Dynamics Ltd Nanosurf New England Biolabs, Inc. Panasonic Biomedical Sales Europe B.V. PerkinElmer Inc ReAgent Russell Finex Limited Source BioScience Takara Clontech Tornado Spectral Systems Tuttnauer Watson-Marlow Fluid Technology Group Wickham Laboratories Limited Xylem Analytics YMC Europe GmbH Yusen Logistics