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Clinical Trials

Date: 2017-01-16

Type of information: Initiation of the trial

phase: 2

Announcement: initiation of the trial

Company: Hutchison China MediTech Limited "ChiMed" (China)

Product: fruquintinib

Action mechanism:

tyrosine kinase inhibitor. Fruquintinib (HMPL-013) is an orally available, small molecule inhibitor of vascular endothelial growth factor receptors (VEGFRs), with potential anti-angiogenic and antineoplastic activities. Upon oral administration, fruquintinib inhibits VEGF-induced phosphorylation of VEGFRs 1, 2, and 3 which may result in the inhibition of migration, proliferation and survival of endothelial cells, microvessel formation, the inhibition of tumor cell proliferation, and tumor cell death.  It is currently under the joint development in China by Chi-Med and its partner Eli Lilly. Two late-stage, pivotal Phase III registration studies are ongoing in colorectal cancer (FRESCO) and lung cancer (FALUCA). In addition, fruquintinib is also in clinical development for gastric cancer.

Disease: non-small cell lung cancer (NSCLC)

Therapeutic area: Cancer - Oncology

Country: China

Trial details:

This Phase II combination therapy study is a multi-center, single-arm, open-label study. The objectives are to evaluate the safety and tolerability as well as preliminary efficacy of the combination therapy in the first-line setting for advanced or metastatic non-squamous NSCLC patients with epidermal growth factor receptor (“EGFR”) activating mutations. Treatment will be continued until disease progression or intolerable toxicity occurs. (NCT02976116)

Latest news:

* On January 16, 2017, Hutchison China MediTech Limited (“Chi-Med”) announced that it has initiated a Phase II study of a combination therapy using fruquintinib and Iressa® in the first-line setting for patients with advanced or metastatic non-small cell lung cancer in China. The first drug dose was administered on January 9, 2017.

Is general: Yes