Safety and Tolerance Study of Oral Doses of CT53518 to Treat Patients With Acute Myelogenous Leukemia (AML)
NCT00064584 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2009-03-24
Summary
This is the first study of the drug CT53518 when given to humans. The purpose of this study is to determine the highest dose of CT53518 that can safely be given to patients with Acute Myelogenous Leukemia (AML) and to identify the side effects associated with taking the drug. The study will evaluate how CT53518 is absorbed, broken down, and eliminated by the body. Additionally, the study will evaluate the effects of the drug on a specific type of cell in bone marrow and blood, known as a blast.
Conditions
- Acute Myelogenous Leukemia
- Myelodysplastic Syndrome
Interventions
- DRUG
-
CT53518
Sponsors & Collaborators
-
Millennium Pharmaceuticals, Inc.
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2002-05-31
- Primary Completion
- 2005-01-31
- Completion
- 2005-07-31
Countries
- United States
Study Locations
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