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Sponsored by: |
Millennium Pharmaceuticals, Inc. |
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Information provided by: | Millennium Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00830518 |
This is an open-label, multicenter, phase 2 study of MLN8237 in patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).
Condition | Intervention | Phase |
---|---|---|
Acute Myelogenous Leukemia High-Grade Myelodysplastic Syndrome |
Drug: MLN8237 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment |
Official Title: | A Phase 2 Trial of MLN8237, an Oral Aurora A Kinase Inhibitor, in Adult Patients With Acute Myelogenous Leukemia and High-Grade Myelodysplastic Syndrome |
Estimated Enrollment: | 41 |
Study Start Date: | February 2009 |
Estimated Study Completion Date: | November 2011 |
Estimated Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
MLN8237
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Drug: MLN8237
MLN8237 will be administered orally (PO) at a dose of 50 mg twice daily (BID) for seven consecutive days followed by a 14-day rest period, in 21-day cycles. Dose reductions will be implemented in the setting of drug-related toxicities. The first dose of MLN8237 on Cycle 1, Day 1 will be administered in the study clinic. Patients will continue to receive repeated cycles of MLN8237 treatment for up to 12 months, or until there is evidence of disease progression or unacceptable treatment-related toxicity. Treatment with MLN8237 may be continued beyond 12 months if it is determined that a patient would clearly derive benefit from continued therapy. |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Each patient must meet all of the following inclusion criteria:
Eligible diagnoses:
Female patients:
Male patients:
Exclusion Criteria:
Contact: For an updated listing of recruitment sites contact: Millennium Medical and Drug Information Center | 1-866-835-2233 | medical@mlnm.com |
United States, New Jersey | |
Hematology and Oncology Associates of Northern New Jersey | Recruiting |
Morristown, New Jersey, United States, 07962 | |
Contact: Michael Scola, MD 973-538-5210 | |
Principal Investigator: Michael Scola, MD |
Study Director: | Medical Monitor | Millennium Pharmaceuticals, Inc. |
Responsible Party: | Millennium Pharmaceuticals, Inc. ( Clinical Study Medical Monitor ) |
Study ID Numbers: | C14005 |
Study First Received: | January 27, 2009 |
Last Updated: | April 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00830518 History of Changes |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
Leukemia Acute Myelocytic Leukemia Preleukemia Acute Myeloid Leukemia, Adult Precancerous Conditions |
Hematologic Diseases Myelodysplastic Syndromes Leukemia, Myeloid Bone Marrow Diseases Leukemia, Myeloid, Acute |
Neoplasms by Histologic Type Disease Precancerous Conditions Hematologic Diseases Myelodysplastic Syndromes Leukemia, Myeloid Leukemia, Myeloid, Acute |
Leukemia Preleukemia Neoplasms Pathologic Processes Syndrome Bone Marrow Diseases |