Hutchison China MediTech (Chi-Med) has launched a Phase I clinical trial of fruquintinib to treat patients with solid tumours in the US.

Fruquintinib is an oral, selective and potent inhibitor of 1, 2 and 3 vascular endothelial growth factor receptors (VEGFR).

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The multi-centre, non-randomised, open-label, Phase I trial is designed to investigate the safety, tolerability and pharmacokinetics of fruquintinib in subjects with advanced tumours.

Expected to enrol around 18 patients, the trial’s primary outcome measure is adverse events assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE).

In addition, the trial will measure secondary outcomes such as recommended Phase II dose, time to reach maximum plasma concentration, metabolite profile, and anticancer activity.

“The trial will measure secondary outcomes such as recommended Phase II dose.”

It is estimated that the Phase I trial in the US will be completed in December 2019.

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In China, the investigational candidate is reported to have met its primary endpoint in different Phase II and III clinical trials performed in patients with colorectal, lung and gastric cancers.

Fruquintinib is undergoing separate Phase III trials with 416 advanced colorectal cancer (CRC) patients, 520 subjects with non-small cell lung cancer (NSCLC), and 500 volunteers suffering from advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma. The drug is developed in collaboration with Eli Lilly.

In addition, the drug candidate is being further studied in a Phase II combination trial with Iressa (gefitinib) in first-line setting for advanced or metastatic NSCLC.