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

This study has been terminated.

(Trial stopped June 2007)

Sponsor:

Information provided by:

SGX Pharmaceuticals, Inc.

ClinicalTrials.gov Identifier:

NCT00104468

First received: February 28, 2005

Last updated: January 14, 2008

Last verified: January 2008

History of Changes

Tracking Information
First Received Date ^ICMJE	February 28, 2005
Last Updated Date	January 14, 2008
Start Date ^ICMJE	April 2003
Primary Completion Date	June 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 23, 2005)	To determine the recommended infusion schedule for the investigational new drug administered as a continuous infusion with regards to dose limiting toxicities.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00104468 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 23, 2005)	Pharmacokinetic/pharmacodynamic profile, preliminary evidence of the anti-tumor activity.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Study of Troxatyl™ Administered by Continuous Infusion to Subjects With Refractory Acute Myelogenous Leukemia (AML)
Official Title ^ICMJE	An Open-Label, Single-Arm, Multi-Center, Phase I Study of Troxatyl™ (Troxacitabine) Administered by Continuous Infusion in Subjects With Refractory Acute Myelogenous Leukemia
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
Study Type ^ICMJE	Interventional
Study Phase	Phase 1 Phase 2
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Acute Myelogenous Leukemia
Intervention ^ICMJE	Drug: Troxatyl™ (Cytotoxic Chemotherapeutic)
Study Arm (s)
Publications *	Giles FJ. Troxacitabine-based therapy of refractory leukemia. Expert Rev Anticancer Ther. 2002 Jun;2(3):261-6. Review.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	50
Completion Date	June 2007
Primary Completion Date	June 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00104468
Other Study ID Numbers ^ICMJE	SPD758-110
Has Data Monitoring Committee
Responsible Party
Study Sponsor ^ICMJE	SGX Pharmaceuticals, Inc.
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	SGX Pharmaceuticals, Inc.
Verification Date	January 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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