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

This study has been terminated.
Sponsor:
Information provided by:
SGX Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00129948
First received: August 10, 2005
Last updated: November 1, 2006
Last verified: November 2006
  Purpose

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 Intervention Phase
Leukemia, Myeloid, Acute
Drug: Troxatyl™ (troxacitabine)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by SGX Pharmaceuticals, Inc.:

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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 211
Study Start Date: July 2005
Estimated Study Completion Date: October 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00129948

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

No publications provided

ClinicalTrials.gov Identifier: NCT00129948     History of Changes
Obsolete Identifiers: NCT00310193
Other Study ID Numbers: SPD758-216
Study First Received: August 10, 2005
Last Updated: November 1, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by SGX Pharmaceuticals, Inc.:
Acute myeloid leukemia
AML
refractory
relapsed

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

ClinicalTrials.gov processed this record on September 18, 2014