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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00104468
Recruitment Status : Terminated (Trial stopped June 2007)
First Posted : March 1, 2005
Last Update Posted : January 17, 2008
Information provided by:
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™.

Condition or disease Intervention/treatment Phase
Acute Myelogenous Leukemia Drug: Troxatyl™ (Cytotoxic Chemotherapeutic) Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Single-Arm, Multi-Center, Phase I Study of Troxatyl™ (Troxacitabine) Administered by Continuous Infusion in Subjects With Refractory Acute Myelogenous Leukemia
Study Start Date : April 2003
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Primary Outcome Measures :
  1. 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 :
  1. Pharmacokinetic/pharmacodynamic profile, preliminary evidence of the anti-tumor activity.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00104468

United States, New York
Cornell Medical College, New York Presbyterian
New York, New York, United States, 10021
United States, Texas
MD Anderson
Houston, Texas, United States, 77030
Sponsors and Collaborators
SGX Pharmaceuticals, Inc.

Publications: Identifier: NCT00104468     History of Changes
Other Study ID Numbers: SPD758-110
First Posted: March 1, 2005    Key Record Dates
Last Update Posted: January 17, 2008
Last Verified: January 2008

Keywords provided by SGX Pharmaceuticals, Inc.:
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

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Antineoplastic Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents