Study for Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)

November 1, 2006 updated by: SGX Pharmaceuticals, Inc.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

211

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • LaJolla, California, United States, 92037
        • Scripps Clinic
      • Los Angeles, California, United States, 90033
        • USC-Norris Neuro-Oncology Program
      • San Diego, California, United States, 92093
        • UCSD Moores Cancer Center
    • Florida
      • Jacksonville, Florida, United States, 32209
        • Univ. of Florida, Baptist Cancer Center
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Winship Cancer Institute, Emory University Hosp.
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana Farber Cancer Institute
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Harper Hospital - Karmanos Cancer Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Univ. of Minnesota Medical Center
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
      • New York, New York, United States, 10021
        • Memorial Sloan-Kettering Cancer Center
      • New York, New York, United States, 10021
        • New York Presbyterian Hospital-Cornell Campus
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Univ. School of Medicine
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Univ. of South Carolina, Hematology/Oncology Division
    • Texas
      • Houston, Texas, United States, 77030
        • Univ. of Texas, MD Anderson Cancer Center
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • University of Utah Huntsman Cancer Institute
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
        • Morgantown Internal Medicine Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To determine complete response (CR) rate

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SGX Pharmaceuticals, Inc.

Investigators

  • Principal Investigator: Francis Giles, MD, M.D. Anderson Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Study Completion

October 1, 2007

Study Registration Dates

First Submitted

August 10, 2005

First Submitted That Met QC Criteria

August 10, 2005

First Posted (Estimate)

August 12, 2005

Study Record Updates

Last Update Posted (Estimate)

November 3, 2006

Last Update Submitted That Met QC Criteria

November 1, 2006

Last Verified

November 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPD758-216

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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