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

Stopped early · Phase 2

Conditions studied: Leukemia, Myeloid, Acute

In brief

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.

Key facts

Study ID: NCT00129948
Run by: SGX Pharmaceuticals, Inc.
People needed: 211
Starts: 2005-07-01
Expected to finish: 2007-10-01
Last updated by the study team: 2006-11-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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

Where it is running

Scripps Clinic — La Jolla, California, United States
USC-Norris Neuro-Oncology Program — Los Angeles, California, United States
UCSD Moores Cancer Center — San Diego, California, United States
Univ. of Florida, Baptist Cancer Center — Jacksonville, Florida, United States
Winship Cancer Institute, Emory University Hosp. — Atlanta, Georgia, United States
University of Chicago — Chicago, Illinois, United States
Loyola University Medical Center — Maywood, Illinois, United States
Dana Farber Cancer Institute — Boston, Massachusetts, United States
Harper Hospital - Karmanos Cancer Center — Detroit, Michigan, United States
Univ. of Minnesota Medical Center — Minneapolis, Minnesota, United States
Washington University School of Medicine — St Louis, Missouri, United States
Roswell Park Cancer Institute — Buffalo, New York, United States
Memorial Sloan-Kettering Cancer Center — New York, New York, United States
New York Presbyterian Hospital-Cornell Campus — New York, New York, United States
Wake Forest Univ. School of Medicine — Winston-Salem, North Carolina, United States
Cleveland Clinic Foundation — Cleveland, Ohio, United States
Univ. of South Carolina, Hematology/Oncology Division — Charleston, South Carolina, United States
Univ. of Texas, MD Anderson Cancer Center — Houston, Texas, United States
University of Utah Huntsman Cancer Institute — Salt Lake City, Utah, United States
Morgantown Internal Medicine Group — Morgantown, West Virginia, United States

Full record on ClinicalTrials.gov

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