Safety and Efficacy Study of ARQ 501 in Adult Patients With Leiomyosarcoma

Inclusion Criteria

• •Able to provide signed and dated informed consent prior to study-specific screening procedures.
• •Histologically or cytologically confirmed leiomyosarcoma that is persistent, recurrent or metastatic.
• •Measurable disease as defined by RECIST.
• •Karnofsky performance status \>= 70%
• •Male or female patients of child-producing potential must agree to use contraception or avoidance of pregnancy measures during the study and for 30 days after the last infusion of ARQ 501.
• •Hemoglobin (Hgb) \>= 10 g/dL.
• •Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L (\>= 1,500/mm3).
• •Platelet count \>= 100 x 10\^9/L (\>= 100,000/mm3).
• •Total bilirubin less than or equal to 1.5 x upper limit of normal (ULN) or less than or equal to 3.0 x ULN with metastatic liver disease.
• •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 2.5 x ULN less than or equal to 5.0 ULN with metastatic liver disease.
• •Creatinine less than or equal to 1.5 x ULN.