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

Sponsored by:	SGX Pharmaceuticals, Inc.
Information provided by:	SGX Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00104468

Purpose

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™.

Condition	Intervention	Phase
Acute Myelogenous Leukemia	Drug: Troxatyl™ (Cytotoxic Chemotherapeutic)	Phase I Phase II

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Troxacitabine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by SGX Pharmaceuticals, Inc.:

Primary Outcome Measures:

To determine the recommended infusion schedule for the investigational new drug administered as a continuous infusion with regards to dose limiting toxicities.

Secondary Outcome Measures:

Pharmacokinetic/pharmacodynamic profile, preliminary evidence of the anti-tumor activity.

Estimated Enrollment:	50
Study Start Date:	April 2003
Study Completion Date:	June 2007
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00104468

Locations

United States, New York
Cornell Medical College, New York Presbyterian
New York, New York, United States, 10021
United States, Texas
MD Anderson
Houston, Texas, United States, 77030

Sponsors and Collaborators

SGX Pharmaceuticals, Inc.

More Information

Publications:

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

Study ID Numbers:	SPD758-110
Study First Received:	February 28, 2005
Last Updated:	January 14, 2008
ClinicalTrials.gov Identifier:	NCT00104468
Health Authority:	United States: Food and Drug Administration

Keywords provided by SGX Pharmaceuticals, Inc.:

Single-arm, open-label, multi-center, dose escalation, continuous infusion, multi-dose, acute myeloid leukemia
Acute myelogenous leukemia (AML) that has been refractory to prior therapy and/or is unlikely to benefit from known therapies

Study placed in the following topic categories:

Troxacitabine
Leukemia
Acute myelogenous leukemia

Leukemia, Myeloid
Leukemia, Myeloid, Acute
Acute myelocytic leukemia

Additional relevant MeSH terms:

Anti-Infective Agents
Neoplasms
Anti-HIV Agents
Neoplasms by Histologic Type
Anti-Retroviral Agents

Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009