Study of Troxatyl™ Administered by Continuous Infusion to Subjects With Refractory Acute Myelogenous Leukemia (AML)

SGX Pharmaceuticals

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Acute Myelogenous Leukemia

Treatments

Drug: Troxatyl™ (Cytotoxic Chemotherapeutic)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00104468

SPD758-110

Details and patient eligibility

About

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™.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.