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

Leukemia, Myeloid, Acute Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00129948
• Other study ID #: SPD758-216
• Status: Terminated
• Phase: Phase 2
• First received: August 10, 2005
• Last updated: November 1, 2006
• Start date: July 2005
• Est. completion date: October 2007

Study information

• Verified date: November 2006
• Source: SGX Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00310193

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 211
• Est. completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• Troxatyl™ (troxacitabine)

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
SGX Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine complete response (CR) rate
Secondary	To determine the complete response with incomplete platelet recovery (CRp) rate, and recurrent disease (RD) rates
Secondary	Efficacy and safety, preliminary evidence of the anti-tumor activity, determination of Troxatyl™ infusion pharmacokinetic parameters