Study of Troxatyl™ Administered by Continuous Infusion to Subjects With Refractory Acute Myelogenous Leukemia (AML)
Stopped early · Phase 1/Phase 2
Conditions studied: Acute Myelogenous Leukemia
In brief
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™.
Key facts
- Study ID
- NCT00104468
- Run by
- SGX Pharmaceuticals, Inc.
- People needed
- 50
- Starts
- 2003-04-01
- Expected to finish
- 2007-06-01
- Last updated by the study team
- 2008-01-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Cornell Medical College, New York Presbyterian — New York, New York, United States
- MD Anderson — Houston, Texas, United States
Full record on ClinicalTrials.gov
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