Study of Troxatyl™ Administered by Continuous Infusion to Subjects With Refractory Acute Myelogenous Leukemia (AML)
Study of Troxatyl™ Administered by Continuous Infusion to Subjects With Refractory Acute Myelogenous Leukemia (AML)
This is a phase I, single-arm, open-label, multi-center study of rising doses of Troxatyl™
 whose purpose is to determine the safety, tolerance, and pharmacokinetics, and to establish
 the recommended infusion schedule of Troxatyl™.
Inclusion Criteria:

 -  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

 Exclusion Criteria:

 -  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
 study follow-up

 -  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.