Acute Myelogenous Leukemia
Conditions
Keywords
Single-arm, open-label, multi-center, dose escalation, continuous infusion, multi-dose, acute myeloid leukemia, Acute myelogenous leukemia (AML) that has been refractory to prior therapy and/or is unlikely to benefit from known therapies
Brief summary
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™.
Interventions
Sponsors
SGX Pharmaceuticals, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the recommended infusion schedule for the investigational new drug administered as a continuous infusion with regards to dose limiting toxicities. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic/pharmacodynamic profile, preliminary evidence of the anti-tumor activity. | — |
Countries
United States
Outcome results
None listed