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

NCT ID: NCT00129948

Last Updated: 2006-11-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 211 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-07-31
• Study Completion Date: 2007-10-31

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.

Conditions

Leukemia, Myeloid, Acute

Keywords

Acute myeloid leukemia; AML; refractory; relapsed

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Troxatyl™ (troxacitabine)

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SGX Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Principal Investigators

Francis Giles, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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

Countries

United States

Other Identifiers

SPD758-216

Identifier Type: -

Identifier Source: org_study_id

NCT00310193

Identifier Type: -

Identifier Source: nct_alias