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| Sponsored by: |
Millennium Pharmaceuticals, Inc. |
| Information provided by: | Millennium Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00064584 |
Purpose
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.
| Condition | Intervention | Phase |
|
Acute Myelogenous Leukemia Myelodysplastic Syndrome |
Drug: CT53518 |
Phase I |
| MedlinePlus related topics: | Leukemia, Adult Acute Leukemia, Adult Chronic |
| Drug Information available for: | 1-Piperazinecarboxamide, 4-(6-methoxy-7-(3-(1-piperidinyl)propoxy)-4-quinazolinyl)-N-(4-(1-methylethoxy)phenyl)- |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety Study |
| Official Title: | Tolerability and PK/PD of Multiple Oral Doses of CT53518 in Patients With Acute Myelogenous Leukemia |
| Estimated Enrollment: | 60 |
| Study Start Date: | May 2002 |
This is a Phase 1, open label, dose escalating study at five clinical sites to determine dose limiting toxicity (DLT), maximum tolerated dose (MTD), pharmacokinetics, and the effect on the peripheral and bone marrow blast count of an oral 28-day course of CT53518 in patients with Acute Myelogenous Leukemia (AML) and myelodysplastic syndrome. This study will confirm the tolerability and assess the effects on the peripheral and bone marrow blast count of an oral 28-day course of CT53518 at or near the maximum tolerated dose in patients with AML displaying a specified mutation of the FLT-3 gene, internal tandem duplication (ITD).
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Each patient must meet the following inclusion criteria to be eligible to participate in the study.
Men and women who are over 18 years of age and have one of the following conditions:
Exclusion Criteria:
Patients meeting any of the following criteria are not eligible to participate in the study:
Contacts and Locations| United States, California | |||||
| UCLA Medical Center | |||||
| Los Angeles, California, United States, 90095 | |||||
| United States, Massachusetts | |||||
| Dana Farber Cancer Institute | |||||
| Boston, Massachusetts, United States, 02115 | |||||
| United States, New York | |||||
| Memorial Sloan Kettering Cancer Center | |||||
| New York, New York, United States, 10021 | |||||
| United States, Ohio | |||||
| Ohio State University Medical Center | |||||
| Columbus, Ohio, United States, 43210 | |||||
| United States, Oregon | |||||
| Oregon Health Sciences University | |||||
| Portland, Oregon, United States, 97201 | |||||
| Millennium Pharmaceuticals, Inc. |
More Information
| Study ID Numbers: | 01-301 |
| First Received: | July 9, 2003 |
| Last Updated: | January 2, 2008 |
| ClinicalTrials.gov Identifier: | NCT00064584 |
| Health Authority: | United States: Food and Drug Administration |
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