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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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Acute Myelogenous Leukemia

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Authority:

United States: Food and Drug Administration

Study ID:

SPD758-110

NCT ID:

NCT00104468

Start Date:

April 2003

Completion Date:

June 2007

Related Keywords:

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

Name

Location

Cornell Medical College, New York PresbyterianNew York, New York  10021
MD AndersonHouston, Texas  77230