A Phase 2 Multi Center Open Label Study of ARQ 501 in Adult Patients With Recurrent, Persistent or Metastatic Leiomyosarcoma
- Able to provide signed and dated informed consent prior to study-specific screening
- 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.
- Received three or more prior anticancer chemotherapy regimens.
- Have active, uncontrolled systemic infection considered opportunistic, life
threatening or clinically significant at the time of treatment.
- Have received anticancer chemotherapy, immunotherapy, radiotherapy, surgery or
investigational agents within four weeks of first infusion.
- Have symptomatic or untreated central nervous system (CNS) involvement.
- Are pregnant or breastfeeding.
- Previous exposure to ARQ 501.