An Open-Label, Single-Arm, Multi-Center, Phase I Study of Troxatyl™ (Troxacitabine) Administered by Continuous Infusion in Subjects With Refractory Acute Myelogenous Leukemia
- Confirmed diagnosis of acute myelogenous leukemia (AML) refractory to prior therapy
and/or unlikely to benefit from known therapies.
- Subjects must have adequate organ and immune function as indicated by the following
laboratory values: *Creatinine clearance ≥5 L/hr (83mL/min), *Total Bilirubin
≤2.0 mg/dL (≤34.2 µmol/L), *AST(SGOT) and ALT(SGPT) ≤3 x ULN
- Clinical evidence of active central nervous system (CNS) leukemic involvement
- Active and uncontrolled infection
- Uncontrolled medical problems unrelated to the malignancy that impair their ability
to give informed consent or unacceptably reduce the safety of the proposed treatment
- Neurologic or psychiatric disorders that would interfere with informed consent or
- Known or suspected intolerance or hypersensitivity to the investigational new drug or
closely related compounds like lamivudine, and/or a recent history of alcohol or
other substance abuse.
- Also not eligible are subjects who have used another investigational agent or
participated in a clinical trial within the last 14 days prior to enrollment.
- Females with a positive pregnancy test at screening or subjects that have previously
been enrolled into this study and subsequently withdrew.