Study for Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)
- Conditions
- Leukemia, Myeloid, Acute
- Registration Number
- NCT00129948
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 211
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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.
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Patients must have received at least two previous courses of induction chemotherapy to be considered in the second salvage setting.
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Patients who are in second relapse, must have had a duration of their second CR or CRp of less than six months.
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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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method To determine complete response (CR) rate
- Secondary Outcome Measures
Name Time Method Efficacy and safety, preliminary evidence of the anti-tumor activity, determination of Troxatyl™ infusion pharmacokinetic parameters To determine the complete response with incomplete platelet recovery (CRp) rate, and recurrent disease (RD) rates
Trial Locations
- Locations (20)
New York Presbyterian Hospital-Cornell Campus
🇺🇸New York, New York, United States
Univ. of Florida, Baptist Cancer Center
🇺🇸Jacksonville, Florida, United States
USC-Norris Neuro-Oncology Program
🇺🇸Los Angeles, California, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Winship Cancer Institute, Emory University Hosp.
🇺🇸Atlanta, Georgia, United States
Scripps Clinic
🇺🇸LaJolla, California, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Washington University School of Medicine
🇺🇸St. Louis, Missouri, United States
Morgantown Internal Medicine Group
🇺🇸Morgantown, West Virginia, United States
UCSD Moores Cancer Center
🇺🇸San Diego, California, 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
Wake Forest Univ. School of Medicine
🇺🇸Winston-Salem, North Carolina, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, 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
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Univ. of South Carolina, Hematology/Oncology Division
🇺🇸Charleston, South Carolina, United States