Date: 2013-01-18
Type of information:
phase: 1
Announcement: initiation
Company: AstraZeneca (UK) Cancer Research UK’s Drug Development Office (UK)
Product: AZD0424
Action mechanism: AZD0424 works by blocking two proteins called Src and ABL1 – found in high levels in cancer cells. The proteins have an important role in cell growth and blood vessel development. Laboratory studies have shown that AZD0424 blocks these proteins, preventing delivery of nutrients via blood vessels to cancer cells – stopping their growth.
Disease: various solid tumors
Therapeutic area: Cancer - Oncology
Country: UK
Trial
details: This first-ever phase I trial of the AstraZeneca-owned drug is led from the Oxford Cancer Research UK Cancer Centre based at the Churchill Hospital. The purpose of this study is to determine the maximum tolerated dose of the oral Src/Abl inhibitor AZD0424, and to find tolerable and effective AZD0424 combination regimens for the treatment of advanced solid tumours. It will recruit up to 30 patients, initially across all solid tumor types. Later the design of the trial will be adapted, enabling the study to separate into three separate ‘personalised’ arms. Each of these future arms will test AZD0424 in different combinations alongside standard or other experimental treatments in specific patient populations. The Edinburgh and Belfast Cancer Research UK Centres are also involved as clinical sites, carrying out research to guide the drugs to be used in combination with AZD0424 and the specific patient groups involved in the trial. (NCT01668550)
Latest
news: * On January 18, 2013, Cancer Research UK’s Drug Development Office (DDO) announced that, in partnership with AstraZeneca, it has opened a unique three-armed study of a new investigational drug called AZD0424 that is being tested for the treatment of a range of cancers. This is the first time the DDO has undertaken an adaptive design trial of this type - one where the planned combination treatment to be given to patients is modified as the trial progresses. Cancer Research UK has carried out the preclinical development work of AZD0424 through the charity’s Clinical Development Partnerships (CDP) scheme. CDP is a joint initiative between the DDO and the charity’s commercial arm, Cancer Research Technology, to put drugs that otherwise would not be developed by pharmaceutical companies through early phase clinical trials. The scheme lets companies keep the background rights to their programmes while enabling Cancer Research UK to take on early development work, to see if there is a benefit to cancer patients. The trial is also supported by the National Institute for Health Research Oxford Biomedical Research Centre, and the Cancer Research UK and National Institute for Health Research (NIHR) Experimental Cancer Medicine Centre Network.
