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

Phase 1

Terminated

• Conditions: Acute Myelogenous Leukemia

• Registration Number: NCT00104468
• Lead Sponsor: SGX Pharmaceuticals, Inc.

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™.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-04
• Study First Submitted: 2005-02-28
• Study First Submitted QC: 2005-02-28
• Study First Posted: 2005-03-01
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Status Verified: 2008-01
• Last Update Submitted: 2008-01-14
• Last Update Posted: 2008-01-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To determine the recommended infusion schedule for the investigational new drug administered as a continuous infusion with regards to dose limiting toxicities.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic/pharmacodynamic profile, preliminary evidence of the anti-tumor activity.

Trial Locations

Locations (2)

Cornell Medical College, New York Presbyterian; 🇺🇸 New York, New York, United States

MD Anderson; 🇺🇸 Houston, Texas, United States