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Sponsored by: |
Millennium Pharmaceuticals, Inc. |
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Information provided by: | Millennium Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00697346 |
This is an open-label, multicenter, phase 1 study of MLN8237 in subjects with advanced hematological malignancies for whom there are limited standard treatment options.
Condition | Intervention | Phase |
---|---|---|
B-Cell Follicular Lymphoma B-Cell Marginal Zone Lymphoma Diffuse Large B-Cell Lymphoma B-Cell Mantle Cell Lymphoma B-Cell Small Lymphocytic Lymphoma (SLL) B-Cell Chronic Lymphocytic Leukemia (B-CLL) Multiple Myeloma Waldenstrom's Macroglobulinemia |
Drug: MLN8237 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment |
Official Title: | An Open-Label, Phase 1 Study of MLN8237, a Novel Aurora A Kinase Inhibitor, in Patients With Advanced Hematological Malignancies |
Estimated Enrollment: | 57 |
Study Start Date: | June 2008 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
MLN8237
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Drug: MLN8237
The starting dosage will be 25 mg twice daily (BID) on Day 1 of each cycle followed by 25 mg once daily (QD) on Day 2-21. The planned rest period is 7 days in length. Number of Cycles: until progression or unacceptable toxicity develops. |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Relapsed or refractory disease and a histologically or cytologically confirmed hematological malignancy of the following type for which standard curative treatment does not exist or is no longer effective:
Exclusion Criteria:
Contact: Christine Colby, Pharm.D. | 1-866-835-2233 | medical@mlnm.com |
United States, Tennessee | |
Sarah Cannon Research Institute | Recruiting |
Nashville, Tennessee, United States, 37203 | |
Contact: Daniel R. Couriel,, M.D. |
Responsible Party: | Millennium Pharmaceuticals, Inc. ( Clinical Study Medical Monitor ) |
Study ID Numbers: | C14003 |
Study First Received: | June 11, 2008 |
Last Updated: | June 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00697346 |
Health Authority: | United States: Food and Drug Administration |
Leukemia, Lymphoid Hematologic Neoplasms Blood Protein Disorders Lymphoma, Mantle-Cell Lymphoma, Follicular Paraproteinemias Hemostatic Disorders Lymphoma, large-cell Lymphoma, B-Cell Leukemia Hemorrhagic Disorders Multiple myeloma Leukemia, Lymphocytic, Chronic, B-Cell Waldenstrom macroglobulinemia Lymphoma |
Chronic lymphocytic leukemia Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Hematologic Diseases Leukemia, B-cell, chronic Blood Coagulation Disorders Vascular Diseases Mantle cell lymphoma Multiple Myeloma Lymphatic Diseases Waldenstrom Macroglobulinemia B-cell lymphomas Leukemia, B-Cell Lymphoproliferative Disorders Lymphoma, Non-Hodgkin |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Immune System Diseases Cardiovascular Diseases |