Status:
TERMINATED
Study of Troxatyl™ Administered by Continuous Infusion to Subjects With Refractory Acute Myelogenous Leukemia (AML)
Lead Sponsor:
SGX Pharmaceuticals, Inc.
Conditions:
Acute Myelogenous Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 i...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
End Date :
June 1 2007
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00104468
Start Date
April 1 2003
End Date
June 1 2007
Last Update
January 17 2008
Active Locations (2)
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1
Cornell Medical College, New York Presbyterian
New York, New York, United States, 10021
2
MD Anderson
Houston, Texas, United States, 77030