NP28679: RO5503781 in Acute Myelogenous Leukaemia

• Research type

  Research Study

• Full title

  Title: A Multi-Centre, Open-Label, Phase I/lB Study of Escalating Doses of R05503781 Administered Orally, as 1) a Single Agent, 2) in Combination with Cytarabine or 3) with cytarabine and anthracycline and 4) Assessing PK and Safety of New Optimised Formulation of RO5503781 with Cytarabine in Patients with Acute Myelogenous Leukaemia (AML)

• IRAS ID

  120225

• Contact name

  Mark Drummond

• Sponsor organisation

  F Hoffmann-La Roche Ltd.

• Eudract number

  2012-004882-41

• 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 health, advanced age, or poor likelihood of responding, no established treatment exists. This study aims to determine the maximum dose (amount) of RO5503781 that can be given safely by itself, and also with cytarabine, a drug currently used as a standard treatment of AML. The study will also determine the recommended dose of RO5503781 that can be used in future studies. The study will look at the side effects and safety of the combination of both drugs in these AML patients.A total of 65-75 patients will be recruited into the study globally. The study will look at multiple dose levels of RO5503781 by itself (part 1) and in combination with cytarabine (part 2). There will be 3- 5 cohorts (groups) in Part 1 and Part 2, with 1-6 patients in each group. Each group will receive a different dose of RO5503781, starting with the lowest dose first. RO5503781will be taken by mouth once daily for 5 days, for each 28 day cycle. Patients in Part 2 will also receive cytarabine intravenously (on days 1-6) for each 28 day cycle. In part 2 once the recommended future dose of RO5503781with cytarabine has been ascertained, recruitment will start into an extension/ tail group , where approximately 30 patients will receive treatment with the recommended future dose of RO5503781 and cytarabine. The study will continue for approximately 1 year.In the UK it is expected that approximately 7 patients will be enrolled at one participating study centre.The study is sponsored by F. Hoffman-La Roche Ltd.

• REC name

  Scotland A REC

• REC reference

  13/SS/0026

• Date of REC Opinion

  5 Mar 2013

• REC opinion

  Favourable Opinion