AC220 in adults with refractory/relapsed Acute Myeloid Leukaemia
Research type
Research Study
Full title
A Phase 2, Randomized, Open-Label Study of the Safety and Efficacy of Two Doses of Quizartinib (AC220; ASP2689) in Subjects with FLT3-ITD Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)
IRAS ID
101647
Contact name
Nigel Russell
Sponsor organisation
Ambit BioSciences Corporation
Eudract number
2011-005408-13
Clinicaltrials.gov Identifier
Research summary
Around 2,000 adults are diagnosed with AML each year in the UK. AML is an overproduction of immature (non functional) blood cells in the bone marrow. In most cases, this affects predominantly the white blood cells fighting infection which leads to an increased risk of infection and other severe symptoms. AML is a rare cancer and affects more commonly people over 65, but also any other age. This disease, if untreated, leads to death within weeks and months. Life quality with the disease is very restricted. Astellas Pharma Global Development, Inc. has developed a drug called AC220 which aims to stop uncontrolled immature cell production in the bone marrow. This study wishes to evaluate the overall safety of the drug and particularly the safety of the drug on the heart beat measured by regular electrocardiograms in previously treated patients who??s disease has returned or their treatment was not successful. The study also observes the efficacy of AC220 with focus on disease progress, life quality, duration of life prolongation and the affect of the drug in the patient??s body's well as how the patient??s body reacts on the drug. The study aims to involve approximately 64 adult males and females in approximately 50 hospitals in North America and Europe, chosen per chance within their own gender into the following treatment arms: ?½ Daily oral AC220 30mg ?½ Daily oral AC220 60mg During treatment, participants will undergo examinations and (blood) tests and a bone marrow aspiration. The study will start internationally in March 2012 and lasts until January 2014 with the treatment duration lasting as long as the participant's benefitting from the drug. After the end of the treatment participants will be followed up for 30 days regarding safety, and after this to collect further information regarding disease treatment, disease status and the patient??s overall condition.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
12/YH/0287
Date of REC Opinion
10 Sep 2012
REC opinion
Further Information Favourable Opinion