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Study for Patients With Relapsed or Refractory Acute Myeloid 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: NCT00129948
Recruitment Status : Terminated
First Posted : August 12, 2005
Last Update Posted : November 3, 2006
Information provided by:
SGX Pharmaceuticals, Inc.

Brief Summary:
This is a phase 2, single-arm, open-label, multi-center study to establish the safety and efficacy of Troxatyl™ (troxacitabine) administered as a continuous infusion for 5 days to subjects with AML.

Condition or disease Intervention/treatment Phase
Leukemia, Myeloid, Acute Drug: Troxatyl™ (troxacitabine) Phase 2

Detailed Description:
This is a phase 2, single-arm, open-label, multi-center study to establish the safety and efficacy of Troxatyl™ (troxacitabine) administered as a continuous infusion for 5 days to subjects with AML. The study will primarily assess the complete response (CR) rate of a 5-day continuous infusion of troxacitabine at 12 mg/m2/day given as second salvage therapy in adult patients with AML, with secondary objectives to determine the overall, relapse-free and event-free survival and remission duration; to determine the duration of response; to determine the complete response with incomplete platelet recovery (CRp) rate; to evaluate the tolerability and safety of 5-day continuous intravenous (IV) infusion of troxacitabine; and to determine the relationship between troxacitabine plasma concentrations, anti-leukemic activity and adverse events. Additional cycles of treatment may be given at the investigator’s discretion, provided that the subject does not have progressive disease or experience a dose limiting toxicity. Bone marrow transplantation in responding subjects will be allowed.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 211 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 II Study of Troxatyl™ (Troxacitabine) Administered by Continuous Infusion in Patients With Acute Myeloid Leukemia (AML) in Second Salvage
Study Start Date : July 2005
Study Completion Date : October 2007

Primary Outcome Measures :
  1. To determine complete response (CR) rate

Secondary Outcome Measures :
  1. To determine the complete response with incomplete platelet recovery (CRp) rate, and recurrent disease (RD) rates
  2. Efficacy and safety, preliminary evidence of the anti-tumor activity, determination of Troxatyl™ infusion pharmacokinetic parameters

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Confirmed diagnosis of acute myeloid leukemia (AML) in the second salvage setting: refractory to two prior courses of therapy or primary refractory without response to two previous courses of leukemia therapy.
  • Patients must have received at least two previous courses of induction chemotherapy to be considered in the second salvage setting.
  • Patients who are in second relapse, must have had a duration of their second CR or CRp of less than six months.
  • Subjects must have adequate organ and immune function as indicated by the following laboratory values:

    • Creatinine clearance ≥ 45 mL/min and ≤ 125 mL/min;
    • Total bilirubin ≤ 2.0 mg/dL (≤ 34.2 µmol/L);
    • AST (SGOT) and ALT (SGPT) ≤ 3 x upper limit of normal (ULN).
    • Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of < 2, and an estimated life expectancy of at least eight weeks.

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 patient 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 Troxatyl® or closely related compounds such as lamivudine or any of the stated ingredients
  • A recent history of alcohol or other substance abuse
  • Subjects who have used another investigational agent or participated in a clinical trial within the last 14 days prior to enrolment
  • Females with a positive pregnancy test at screening
  • Subjects who 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): NCT00129948

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Sponsors and Collaborators
SGX Pharmaceuticals, Inc.
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Principal Investigator: Francis Giles, MD M.D. Anderson Cancer Center

Layout table for additonal information Identifier: NCT00129948    
Obsolete Identifiers: NCT00310193
Other Study ID Numbers: SPD758-216
First Posted: August 12, 2005    Key Record Dates
Last Update Posted: November 3, 2006
Last Verified: November 2006
Keywords provided by SGX Pharmaceuticals, Inc.:
Acute myeloid leukemia
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Antineoplastic Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents