A Safety and Efficacy Study of Eltrombopag in Subjects With AML

Inclusion Criteria

- Age >=18 years

- Diagnosed with AML according to the WHO 2008 classification. Note: subjects with
secondary AML following Myelodysplastic syndrome or secondary to previous
leukemogenic therapy are allowed provided that a record of previous MDS history or
leukemogenic therapy history is available.

- Eligible for induction by daunorubicin + cytarabine.

- Eligible to give informed consent to participate in the study.

- Have adequate baseline organ function defined by the following criteria:

Total bilirubin <=1.5 x upper limit of normal (ULN) except for Gilbert's syndrome, or
other conditions that are not indicative of inadequate liver function (i.e. elevation of
indirect bilirubin (haemolytic) in the absence of alanine aminotransferase [ALT]
abnormality).

ALT <=3 x ULN. Serum Creatinine <=2.5 x ULN.

- Adequate cardiac function with LVEF >=50% as assessed by echocardiogram (ECHO) or
Multi Gated Acquisition Scan (MUGA.

- Subjects with a QT interval corrected for heart rate according to Bazett's formula
(QTcB) <450millisecond (msec) or <480msec for subjects with bundle branch block. The
QTc should be based on single or averaged QTc values of triplicate electrocardiograms
(ECGs) obtained over a brief recording period.

- Women must be either of non-childbearing potential or women with child-bearing
potential and men with reproductive potential must be willing to practice acceptable
methods of birth control during the study.

- Men with a female partner of childbearing potential must have either had a prior
vasectomy or agree to use effective contraception from time of randomization until 30
days after the last dose of investigational product.

- Women of childbearing potential must have a negative serum pregnancy test within 7
days of first dose of study treatment and agree to use effective contraception during
the study and for 30 days following the last dose of investigational product.

Exclusion Criteria

- A diagnosis of acute promyelocytic (M3) or acute megakaryocytic leukaemia (M7).

- Previous history of exposure to an anthracycline compound.

- Previous AML treatment (other than hydroxyurea).

- Any serious medical condition, laboratory abnormality, or psychiatric illness that,
in the view of the treating physician, would place the participant at an unacceptable
risk if he or she were to participate in the study or would prevent that person from
giving informed consent.

- History of thromboembolic event or other condition requiring ongoing use of
anticoagulation either with warfarin or low molecular-weight heparin. Note: Occlusion
of a central line is not exclusion.

- Treatment with an investigational drug within 30 days or 5 half lives, whichever is
longer, preceding the first dose of study medication.

- Current and continued use during study treatment period of known Breast cancer
resistance protein (BCRP) inhibitors or known P-gp inhibitors.

- Known active hepatitis B, hepatitis C or Human Immunodeficiency Virus (HIV)
infection.

- Known hypersensitivity to any of the study drugs or its excipients.