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Clinical Trials

Date: 2012-05-17

Type of information: Initiation of the trial

phase:

Announcement: initiation of the trial

Company: Cancer Research UK (UK)

Product: combination of vandetanib and selumetinib

Action mechanism:

tyrosine kinase inhibitor/MEK inhibitor. Vandetanib is a tyrosine-kinase inhibitor. It targets vascular endothelial growth factor receptor (VEGFR), epidermal growth factor receptor (EGFR) and RET (Rearranged during transfection proto-oncogene) receptors. Both VEGF and EGF receptors are active in lung cancer. Blocking these targets prevents the development of new blood vessels and tumour growth. Vandetanib (Caprelsa® - AstraZeneca) has been approved by the European Commission for the treatment of aggressive and symptomatic medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease. The European Commission granted a marketing authorisation valid throughout the European Union on February 2012 (See http://biopharmanalyses.fr/product/?pageid=188).

Selumetinib is a mitogen activated protein kinase (MEK) inhibitor. Ir inhibits mitogen-activated protein kinase kinases (MEK or MAPK/ERK kinases) 1 and 2, which may prevent the activation of MEK1/2-dependent effector proteins and transcription factors, and so may inhibit cellular proliferation in MEK-overexpressing tumor cells. MEK 1 and 2 are dual-specificity kinases that are essential mediators in the activation of the RAS/RAF/MEK/ERK pathway, are often upregulated in various tumor cell types, and are drivers of diverse cellular activities, including cellular proliferation.

Disease: advanced solid tumours
non-small cell lung cancer

Therapeutic area: Cancer - Oncology

Country: UK

Trial details:

The study will take place across three UK hospitals. The Churchill Hospital, Oxford is the lead centre. The trial of up to 48 patients will run in two stages. In the first stage patients with any solid tumour will each receive  vandetanib and an investigational drug called selumetinib (AZD6244, ARRY142886). In the second stage patients with non-small cell lung cancer (NSCLC) will receive the combination. The trial will also run from The Christie, Manchester and Addenbrooke’s Hospital, Cambridge. Patients with advanced NSCLC who meet the eligibility criteria for the trial will be able to participate. NSCLC patients will not be a selective group based upon any specific mutation or biomarker.

Latest news:

Cancer Research UK’s Drug Development Office has opened the first trial of a new drug combination in patients with advanced solid tumours and in a subset of patients who have non-small cell lung cancer. This trial will combine two compounds that aim to starve the tumours while simultaneously blocking cancer cell growth. It is hoped that combining these treatments will increase the number of cancer ‘weakspots’ targeted at the same time.
Last year, Cancer Research UK’s drug development office (DDO) has signed a strategic combinations alliance with AstraZeneca to take combinations of experimental cancer drugs into early phase clinical trials (See http://biopharmanalyses.fr/agreements/?pageid=595).

Is general: Yes