Study of Troxatyl™ Administered by Continuous Infusion to Subjects With Refractory Acute Myelogenous Leukemia (AML)

NCT ID: NCT00104468

Last Updated: 2008-01-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-04-30
• Study Completion Date: 2007-06-30

Brief Summary

This is a phase I, single-arm, open-label, multi-center study of rising doses of Troxatyl™ whose purpose is to determine the safety, tolerance, and pharmacokinetics, and to establish the recommended infusion schedule of Troxatyl™.

Conditions

Acute Myelogenous Leukemia

Study Design

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

Interventions

Troxatyl™ (Cytotoxic Chemotherapeutic)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Confirmed diagnosis of acute myelogenous leukemia (AML) refractory to prior therapy and/or unlikely to benefit from known therapies.
• Subjects must have adequate organ and immune function as indicated by the following laboratory values: *Creatinine clearance ≥5 L/hr (83mL/min), *Total Bilirubin ≤2.0 mg/dL (≤34.2 µmol/L), *AST(SGOT) and ALT(SGPT) ≤3 x ULN

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 their 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 the investigational new drug or closely related compounds like lamivudine, and/or a recent history of alcohol or other substance abuse.
• Also not eligible are subjects who have used another investigational agent or participated in a clinical trial within the last 14 days prior to enrollment.
• Females with a positive pregnancy test at screening or subjects that 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

Locations

Cornell Medical College, New York Presbyterian

New York, New York, United States

MD Anderson

Houston, Texas, United States

Countries

United States

References

Giles FJ. Troxacitabine-based therapy of refractory leukemia. Expert Rev Anticancer Ther. 2002 Jun;2(3):261-6. doi: 10.1586/14737140.2.3.261.

Reference Type: BACKGROUND

PMID: 12113049 (View on PubMed)

Other Identifiers

SPD758-110

Identifier Type: -

Identifier Source: org_study_id