Metabolism, excretion and pharmacokinetics of AZD1152 in AML (Phase 1)

• Research type

  Research Study

• Full title

  A Phase I Open, Non-randomised, Single-centre Study to Assess the Metabolism, Excretion and Pharmacokinetics of AZD1152 and AZD1152 hQPA Following Intravenous Administration of [14C]-AZD1152 in Patients With Acute Myeloid Leukaemia (AML)

• IRAS ID

  19399

• Sponsor organisation

  Astra Zeneca AB

• Eudract number

  2009-010784-17

• Research summary

  This is a Phase I study for patients with Acute Myeloid Leukaemia (AML) who are either not receiving substantial benefit from standard treatment or who have been newly-diagnosed with AML and are not considered suitable for standard treatment. Up to 6 patients will be recruited into this study at currently one site in Manchester.Acute myeloid leukaemia (AML) is the most common type of acute leukaemia in adults and treatment requires an induction regiment to clear certain cancer cells from the bone marrow to allow the growth of new normal bone marrow cells. An enzyme called Aurora kinase B is present in high concentrations in cancer patients and it is believed that preventing this enzyme from working can cause cancer cells to die. The drug to be investigated in this study is AZD1152 and it specifically targets Aurora kinase B enzymes. It is hoped that AZD1152 can be developed to help patients with AML. Patients will receive a version of the drug which has been tagged with a marker. This is known as radio-labelling and enables the drug to be tracked as it moves around the body. The main purpose of this study is to find out about how the body processes AZD1152 i.e. how do blood levels of AZD1152 change over time? How is it broken up by the body? How much of it stays in the body? How is it excreted (removed) from the body? This information will help further develop the drug for use in AML patients.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  09/H1008/78

• Date of REC Opinion

  1 Jun 2009

• REC opinion

  Further Information Favourable Opinion