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

Acute Myelogenous Leukemia Clinical Trial

Official title:

An Open-Label, Single-Arm, Multi-Center, Phase I Study of Troxatyl™ (Troxacitabine) Administered by Continuous Infusion in Subjects With Refractory Acute Myelogenous Leukemia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00104468
• Other study ID #: SPD758-110
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: February 28, 2005
• Last updated: January 14, 2008
• Start date: April 2003
• Est. completion date: June 2007

Study information

• Verified date: January 2008
• 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 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™.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

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

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

Intervention

Drug:
• Troxatyl™ (Cytotoxic Chemotherapeutic)

Locations

Country	Name	City	State
United States	MD Anderson	Houston	Texas
United States	Cornell Medical College, New York Presbyterian	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
SGX Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Giles FJ. Troxacitabine-based therapy of refractory leukemia. Expert Rev Anticancer Ther. 2002 Jun;2(3):261-6. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the recommended infusion schedule for the investigational new drug administered as a continuous infusion with regards to dose limiting toxicities.
Secondary	Pharmacokinetic/pharmacodynamic profile, preliminary evidence of the anti-tumor activity.