AZD4547 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 AZD4547 in Patients with Advanced Solid Malignancies

• IRAS ID

  26584

• Eudract number

  2009-012922-35

• ISRCTN Number

  N/A

• Research summary

  AstraZeneca is conducting a research study with a new anti-cancer agent called AZD4547 in patients with advanced solid tumours. Studies done in the laboratory have shown that AZD4547 helps stop growth of some human cancer cells, therefore patients may benefit from the study, but there is no guarantee. This study is designed to identify a dose of the drug that can be used in the future.As this study drug has never been given to humans before, it will start with a small dose in one patient in a cohort, and increase the dose in subsequent cohorts of patients as the study progresses. The study is divided into two phases. In the first phase, the doses of AZD4547 are increased and the safety and tolerability (i.e. side effects) to each dose level determined. Once the maximum tolerated dose is identified, the number of patients studied at that dose level is increased to confirm the suitability of the dose (second part of the study). We are also doing the study to find out how the body handles AZD4547, i.e. how quickly the body absorbs and removes the drug. We will also study how genes (pieces of DNA) affect the way the body responds to or handles it. Patients will be recruited from 3 clinical centres, one each in the United Kingdom, France and The Netherlands. 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. At these visits patients will undergo assessments to check on their health and see how the drug is working. Patients can remain on AZD4547 treatment for as long as they are receiving benefit and are not experiencing unacceptable side effects.

• REC name

  North East - York Research Ethics Committee

• REC reference

  09/H0903/46

• Date of REC Opinion

  10 Sep 2009

• REC opinion

  Further Information Favourable Opinion