Study of SAR125844 Single Agent Administered as Slow Intravenous Infusion in Adult Patients With Advanced Malignant Solid Tumors

Exclusion Criteria

• •Patient less than 18 years old. ECOG performance status \>2. Any serious active disease or co-morbid condition, which, in the opinion of the Investigator, may interfere with the safety or the compliance with the study.
• •Poor bone marrow reserve as defined by absolute neutrophil count \<1.5 x 10\^9/L or platelets \<100 x 10\^9/L.
• •Poor organ function as defined by one of the following:
• •Total bilirubin \>1.5 x ULN
• •AST, ALT, alkaline phosphatase \>2.5 x ULN or \>5 x ULN in case of documented liver metastasis. Alkaline phosphatase up to 5 x ULN in case of osteolytic bone metastasis without liver metastases is allowed
• •Serum creatinine \>1.5 x ULN or
• •Serum creatinine between 1.0 and 1.5 x ULN associated with calculated creatinine clearance \<60 mL/min
• •Proteinuria \>500 mg/24H Pregnant or breast-feeding women. No use of effective birth control methods, when applicable. No measurable or evaluable tumor lesion in the Dose Escalation part, and no measurable lesions in the expansion cohorts.
• •Brain metastasis (other than totally resected or previously pre-irradiated and no progressive/relapsing) or lepto-meningeal carcinomatosis.
• •No resolution of any specific toxicities (excluding alopecia) related to any prior anti-cancer therapy to grade ≤1 according to the NCI CTCAE v.4.03.
• •Wash out period of less than 3 weeks from previous antitumor therapy or any investigational treatment (and less than 6 weeks in case of prior nitroso-urea and or mitomycin C treatment).
• •Any surgery with major risk of bleeding performed less than 10 days prior to study treatment administration.
• •Any other severe underlying medical conditions, which could impair the ability to participate in the study or the interpretation of its results.
• •Patients treated with potent CYP3A inhibitor unless it can be discontinued at least 2 weeks prior to study treatment or 5 elimination half-life, whichever is the longest.
• •Patients treated with potent and moderate CYP3A inducers unless it can be discontinued at least 2 weeks prior to study treatment or 5 elimination half-life, whichever is the longest. Patients treated with weak CYP3A inducers such as dexamethasone are eligible.
• •Known hypersensitivity or any adverse event related to the study drug excipient.
• •Prior treatment with any compound in the same class. Mean QTc interval prolongation.
• •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.