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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Celgene Corporation |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00087672 |
The goal of this clinical research study is to learn if CC-5013 (lenalidomide) can help to control myelofibrosis. The safety of lenalidomide in the treatment of myelofibrosis will also be studied.
Condition | Intervention | Phase |
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Myelofibrosis |
Drug: CC-5013 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Study of CC-5013 in Myelofibrosis |
Estimated Enrollment: | 41 |
Study Start Date: | July 2004 |
Estimated Study Completion Date: | July 2009 |
Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
CC-5013
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Drug: CC-5013
10 mg orally daily
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Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA
EXCLUSION CRITERIA
United States, Texas | |
M.D. Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Jorge E Cortes, MD | M.D. Anderson Cancer Center |
Responsible Party: | The University of Texas M. D. Anderson Cancer Center ( Jorge Cortes, M.D./ Professor ) |
Study ID Numbers: | 2003-0648 |
Study First Received: | July 12, 2004 |
Last Updated: | May 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00087672 |
Health Authority: | United States: Food and Drug Administration |
Myelofibrosis Phase 2 |
Myeloid Metaplasia Myelofibrosis-osteosclerosis Lymphatic Diseases Myelofibrosis Hematologic Diseases |
Metaplasia Lenalidomide Myeloproliferative Disorders Bone Marrow Diseases |
Antineoplastic Agents Therapeutic Uses Splenic Diseases Pharmacologic Actions |