Study of Troxatyl™ Administered by Continuous Infusion to Subjects With Refractory Acute Myelogenous Leukemia (AML)
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™.
Acute Myelogenous Leukemia
Drug: Troxatyl™ (Cytotoxic Chemotherapeutic)
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- To determine the recommended infusion schedule for the investigational new drug administered as a continuous infusion with regards to dose limiting toxicities.
- Pharmacokinetic/pharmacodynamic profile, preliminary evidence of the anti-tumor activity.
|Study Start Date:||April 2003|
|Study Completion Date:||June 2007|
|Primary Completion Date:||June 2007 (Final data collection date for primary outcome measure)|
|United States, New York|
|Cornell Medical College, New York Presbyterian|
|New York, New York, United States, 10021|
|United States, Texas|
|Houston, Texas, United States, 77030|