Phase I of AZD0424 alone and in combination in advanced solid tumours

• Research type

  Research Study

• Full title

  A Cancer Research UK Phase I study to determine the maximum tolerated dose of the oral Src/ABL inhibitor AZD0424, and to identify tolerable and effective AZD0424 combination regimens for the treatment of advanced solid tumours

• IRAS ID

  106274

• Contact name

  Adrian Harris

• Sponsor organisation

  Cancer Research UK, Drug Development Office

• Eudract number

  2011-001575-40

• ISRCTN Number

  na

• Research summary

  The proposed study is a first in man study to determine the maximum tolerated dose of the oral drug called AZD0424 (as a single agent), and to identify any tolerable and effective established drugs (combination agents) which can be given with AZD0424 for the treatment of advanced solid tumours. Up to three additional combination agents may be looked at in this study. AZD0424 works by slowing down or stopping the activity of proteins (a naturally occurring substance produced by your body) called SRC and ABL1. These proteins are involved in cell growth, cell invasion and metabolism and formation and development of blood vessels. These proteins are seen in higher levels in cancer cells. AZD0424 works by slowing down or stopping the activity of these proteins and has been shown in laboratory and animal studies to stop the growth of cancer cells and tumour. This will be the first study where AZD0424 will be given to patients as single agent and in combination with other established drugs. We now wish to find out if it will be useful in treating patients with cancer. The three main aims of this clinical study are to find out: ?½ The maximum dose of AZD0424 alone that can be given safely to patients. ?½ More about the potential side effects of the drug and how they can be managed. ?½ What happens to AZD0424 inside the body. ?½ The interaction of AZD0424 with the combination agents and the potential side effects of this combination and how they can be managed.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  12/SC/0383

• Date of REC Opinion

  6 Aug 2012

• REC opinion

  Further Information Favourable Opinion