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

Study Overview
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Brief Summary
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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™.

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

Conditions
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Acute Myelogenous Leukemia

Intervention / Treatment
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* Drug: Troxatyl™ (Cytotoxic Chemotherapeutic)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Troxatyl™ (Cytotoxic Chemotherapeutic)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic/pharmacodynamic profile, preliminary evidence of the anti-tumor activity. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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