Intermittent Dosing of AZD8055 in Patients with Advanced Cancers

• Research type

  Research Study

• Full title

  A Phase I, Open-Label, Multi-Centre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of the m-Tor Kinase Inhibitor AZD8055 using Intermittent Dosing Schedules in Patients with Advanced Solid Malignancies and Lymphomas

• IRAS ID

  59486

• Contact name

  Udai Banerji

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2010-022122-33

• ISRCTN Number

  N/A

• Research summary

  AstraZeneca is conducting a research study with an anticancer agent called AZD8055 in patients with advanced cancers. Studies done in the laboratory have shown that AZD8055 stops the growth of some human cancer cells, therefore patients may benefit from participating in the study. This study is designed to identify an appropriate dose of the drug that can be used in the future. As the safe and tolerated dose of the study drug has not been determined using intermittent dosing schedules before, it will start with a dose given to a small group (cohort) of patients. If this dose is tolerated, the dose increases in subsequent cohorts of patients, as the study progresses. There will be two arms to the study; one where patients will only take tablets on a Monday, Wednesday and Friday of every week and the other arm where patients will take the tablets every day for three weeks and then have a week with no tablets. The study will end once a safe and tolerated dose on both arms has been found. We are also doing the study to find out how the body handles AZD8055 (i.e. how quickly the body absorbs and removes the drug) and how the cancer responds to the drug. Patients will be recruited from 3 clinical centres in the UK and USA. If patients consent to enter this study they will then attend hospital visits throughout the study. The visits will be most frequent during the first 28 days of treatment and patient may be asked to stay overnight on a few occasions. At visits, patients will undergo assessments to check on their health and see how the drug is working. Patients can remain on AZD8055 treatment for as long as they are receiving benefit and are not experiencing unacceptable side effects.

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  10/H0606/53

• Date of REC Opinion

  23 Sep 2010

• REC opinion

  Further Information Favourable Opinion