NP28023 MDM2 antagonist in Acute Myelogenous Leukaemia

• Research type

  Research Study

• Full title

  A multi-centre, open label, Phase 1b study of escalating doses of RO5045337 administered orally, with cytarabine administered a)subcutaneously, or b)intravenously, in patients with acute myelogenous leukaemia(AML)

• IRAS ID

  102818

• Contact name

  Mark Drummond

• Sponsor organisation

  F Hoffmann-La Roche Ltd

• Eudract number

  2011-006252-36

• Research summary

  For patients who fail initial treatment for acute myelogenous leukaemia(AML) or who relapse after successful treatment, there is currently no standard treatment regimen available. Survival of these patients, if patients relapse within the first year, is measured in months. Also, there are patients, who have not been previously treated for AML, that due to poor medical condition (poor health), advanced age, or poor likelihood of responding, no established treatment exists. This study aims to determine the maximum dose (amount) of MDM2 antagonist that can be given safely with cytarabine, a drug currently used as a standard treatment of AML. The study will look at the side effects and safety of the combination of both drugs in these AML patients. A total of 30-40 patients will be recruited into the study globally. There will be approximately 4 treatment groups, at least 3 patients will be treated in each group. The study will look at multiple dose levels of MDM2 antagonist and each group will receive a different dose of MDM2 antagonist, starting with the lowest dose first. The MDM2 antagonist will be taken by mouth once or twice daily for 5 days or 10 days, for each 28 day cycle, depending on the study group. Patients will receive cytarabine subcutaneously (once daily for 10 days) or intravenously (on days 1-6), for each 28 day cycle, depending on their treatment group. The study will continue for approximately 1 year. In the UK it is expected that 6-8 patients will be enrolled at two participating study centres. The study is sponsored by F. Hoffman-La Roche Ltd.

• REC name

  Scotland A REC

• REC reference

  12/SS/0081

• Date of REC Opinion

  18 Jun 2012

• REC opinion

  Further Information Favourable Opinion