AZD5363 Safety & Tolerability in Patients with Advanced Solid Tumours

• Research type

  Research Study

• Full title

  A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD5363 under Adaptable Dosing Schedules in Patients with Advanced Solid Malignancies

• IRAS ID

  62131

• Contact name

  Udai Banerji

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2010-022167-35

• ISRCTN Number

  N/A

• Research summary

  AstraZeneca is conducting a research study with AZD5363, a new anticancer agent, in patients with advanced cancers. Laboratory studies have shown that AZD5363 helps to reduce the growth of some cancer cells, therefore patients may benefit from participating in the study, but there is no guarantee. This study is designed to investigate the safety and tolerability of AZD5363 and to identify a dose and schedule that can be used in the future. As this drug has never been given to humans before, it will start with a small dose for one patient, then 7 days later if all is well further patients in this group will be given the capsules twice daily every day (i.e. continuously). On review of the data, if this dose is tolerated, subsequent groups of patients will either take capsules continuously or on certain days during the week. The dose for subsequent groups will increase until a safe and tolerated dose has been found for each dosing schedule. We are also investigating how the body handles AZD5363 (i.e. how quickly the body absorbs and removes the drug) and how genes (building blocks of cells) affect the way the body responds to or handles the drug.Patients will be recruited from 3 clinical centres in Europe. If patients consent to enter this study they will attend hospital visits throughout the study; visits will be most frequent during the first 28 days of treatment. At visits, patients will undergo assessments to check on their health and see how the drug is working. Patients can remain on AZD5363 treatment for as long as they are receiving benefit and are not experiencing unacceptable side effects.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  10/H0806/100

• Date of REC Opinion

  17 Nov 2010

• REC opinion

  Further Information Favourable Opinion