Trial Information

Summary: A Phase I/II, Open-Label, Multi-centre 2-part study to assess the Safety, Tolerability, Pharmacokinetics and Efficacy of AZD1152 in Patients WIth Relapsed Acute Myeloid Leukaemia.

AZD1152 is a new drug being tested for the possible treatment of patients with cancer and leukaemia. The main aims of the study are to determine if it is safe and well tolerated and to see how effective AZD1152 is in patients with acute myeloid leukaemia (AML) that has relapsed following an initial response to standard chemotherapy. The first part of this study (Part A) has started and the main aim is to determine the maximum tolerated dose of study drug that can be safely given over a 7 day period, followed by 14 days of no treatment. This cycle of treatment will be repeated two more times, this should be sufficient time to prove if AZD1152 is effective in treating leukaemia although further cycles will be offered to patients receiving benefit at the discretion of the treating physician. In the second part of the study a group of ~30 patients will be treated at the dose defined in Part A to determine the efficacy of the treatment.

To participate in the study you should fulfil the following criteria:

• Aged 18 years or older
• AML in first relapse, relapse occurring between 3-12 months post completion of a full course of induction & consolidation chemotherapy (this can not include autologous & allogeneic stem cell transplantation)
• A commitment to the study for at least 3 treatment cycles

You are not able to participate if you:

• Have had radiotherapy or chemotherapy in the 4 weeks prior to study entry
• Have undergone major surgery in the 4 weeks prior to study entry

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Trial listings updated: June 1, 2008 at 6:29:58 AM