Safety and Pharmacokinetics of SAR240550 (BSI-201) Twice Weekly in Patients With Advanced Solid Tumors

Inclusion criteria: \- Histologically or cytologically documented advanced solid tumor that was refractory to standard therapy or for which no standard therapy is available Exclusion criteria: * Eastern Cooperative Oncology Group (ECOG) performance status of ≥2 * Known hematological malignancies * Symptomatic or untreated brain metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation, and corticosteroids * Myocardial infarction within 6 months of study Day 1, unstable angina, congestive heart failure with New York Heart Association \>class II, uncontrolled hypertension * Active human immunodeficiency virus infection, hepatitis C virus, or chronic hepatitis B infection * Major surgery within 28 days of study Day 1 * Not recovered from all previous therapies (i.e. radiation, surgery, and medications) * Adverse events related to previous therapies must be Common Terminology Criteria for Adverse Events (CTCAE) grade ≤ 1 (except alopecia) at screening or returned to the subject's baseline prior to their most recent previous therapy * Inadequate organ and bone marrow function Radiation therapy within 14 days of study Day 1 * Chemotherapy or antibody therapy for treatment of underlying malignancy within 21 days of study Day 1 * Concurrent or prior (within 7 days of study Day 1) anticoagulation therapy * Currently enrolled or was enrolled within 30 days of completing other investigational drug study, or receiving other investigational agent not approved for any indications * Subject who had been previously enrolled in this study . Not available for follow-up assessment * Any kind of disorder that compromised the ability of the subject to give written informed consent and/or comply with the study procedures * Patient who is judged by the investigator as not suitable for participation in the study The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.