| Exclusion Criteria: | 1) Age less than 18 years
2) Eastern Cooperative Oncology Group (ECOG) performance status greater than 2
3) Active uncontrolled central nervous system leukemia
4) Cytotoxic therapy within 2 weeks prior to the first dose of SAR103168; For the non cytotoxic agents/Investigational drugs this washout period should be at least 2 weeks or at least 5 half-lives whichever longer. Hydroxyurea must be stopped at least 24 hours prior to the first dose of SAR103168.
5) Lack of recovery from toxicities from prior therapies to grade less than or equal to 1
6) WBC greater than 30 x 10(9)/L prior to the first dose of SAR103168
7) Prior allogeneic stem cell transplantation or donor lymphocytes infusion within 3 months preceding the first dose of SAR103168.
8) Any of the following within 6 months prior to the first dose of SAR103168: Myocardial infarction; Congestive heart failure; Documented angina pectoris; Arrhythmia requiring medication (in particular atrial fibrillation or flutter); Severe conduction disorder (second or third atrio-ventricular block, pacemaker); Coronary/peripheral artery bypass graft surgery. Arterial or venous thromboembolism, deep venous thrombosis
9) Left Ventricular Ejection Fraction of less than 50% by dimensionally echocardiography or Multiple Gated Acquisition scan (MUGA) scan
10) Cardiac ischemia on 12-lead ECG (Will be evaluated and confirmed by a cardiologist): ST segment elevation or depression greater than 1 mm in at least 2 contiguous leads or presence of Qwaves
11) Baseline QTc interval greater than 500 msec
12) Hypertension uncontrolled with appropriate therapy (defined as systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg on two repeated measurements)
13) Active infection (viral, bacterial or fungal) uncontrolled with appropriate therapy
14) Major surgery within 6 weeks prior to the first dose of SAR103168
15) Any other serious active disease or co-morbid medical condition or laboratory abnormality, which may impair the ability to evaluate the drug safety or the compliance with the study
16) Poor organ function defined by one of the following: a. Total bilirubin > 1.5 x upper limit of normal (ULN) unless related to leukemia (i.e. hemolysis) or Gilbert's syndrome b. AST, ALT > 2.5 x ULN c. Serum creatinine > 1.5 x ULN or calculated creatinine clearance < 50 mL/min
17) Patients under treatment with potent inhibitors of CYP3A4 unless these treatments may be stopped at least 3 days prior to the first dose of SAR103168
18) Patients under treatment with CYP3A4 or CYP2C9 inducers, unless these treatments may be stopped at least 3 days prior to the first dose of SAR103168
19) Pregnant or breast-feeding women or refusal to use adequate contraceptive method, when applicable |