Phase I study of AT13148, a novel AGC kinase inhibitor

• Research type

  Research Study

• Full title

  A Cancer Research UK Phase I first in man study of the novel AGC kinase inhibitor AT13148 given orally in patients with advanced solid tumours

• IRAS ID

  87032

• Contact name

  Udai Banerji

• Sponsor organisation

  Cancer Research UK, Drug Development Office

• Eudract number

  2011-003562-32

• ISRCTN Number

  ISRCTN

• Research summary

  This study is looking at a new drug called AT13148 which is a protein kinase inhibitor. They are a new type of drug being used to try to stop the growth of cancers and to kill cancer cells with some types of changes to their genes. The drug is a capsule taken one to three times a week. The first patients will be given a low dose, then small groups will be treated at increasing doses to find the highest safe dose and the best dose for future studies. We will look at what happens to the drug inside the body and what the drug does to the body which will help us decide which patients may benefit from the drug in the future. Ten patients will then be treated at this best dose. The treatment will continue until a patient's cancer starts growing but can continue up to 24 months if the cancer is responding to the drug. It is important to explain that this is the first study of this drug and patients will have advanced cancer so it is unlikely that patients will benefit directly from taking part but the study may help improve the future treatment of cancer. We aim to treat 30 to 40 patients with any type of solid tumour (not a type of blood cancer) for whom there is no further standard treatment available. All patients will receive the drug and will be treated at the Royal Marsden hospital in Sutton, Surrey in England and it is sponsored by Cancer Research UK. Patients will need to visit the hospital weekly for two months and then every fortnight and will need to stay overnight after their first dose. Patients will have regular blood and urine tests, scans and chest X-rays amongst other clinical tests.

• REC name

  London - Central Research Ethics Committee

• REC reference

  11/LO/1860

• Date of REC Opinion

  8 Dec 2011

• REC opinion

  Favourable Opinion