Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Duke University Bayer |
---|---|
Information provided by: | Duke University |
ClinicalTrials.gov Identifier: | NCT00510289 |
The purpose of this study is to evaluate whether sorafenib can increase blood counts, decrease transfusion needs, and slow abnormal blood cell formation or development of leukemia in people with Myelodysplastic Syndrome (MDS).
Condition | Intervention | Phase |
---|---|---|
Myelodysplastic Syndromes Leukemia, Myelomonocytic, Chronic |
Drug: Sorafenib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Phase II Trial of Sorafenib in Patients With Myelodysplastic Syndrome |
Estimated Enrollment: | 58 |
Study Start Date: | July 2006 |
Estimated Study Completion Date: | December 2014 |
Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
all patients: Experimental
sorafenib
|
Drug: Sorafenib
400 mg twice a day 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:
Patients must have a diagnosis of primary or therapy-related myelodysplastic syndrome or myelodysplastic/ myeloproliferative disorders as defined by the WHO
Exclusion Criteria:
Contact: Emily Dill, RN | 919-668-4723 | emily.edmonds@duke.edu |
United States, North Carolina | |
Duke University Medical Center | Recruiting |
Durham, North Carolina, United States, 27710 | |
Contact: Emily Dill, RN 919-668-4723 emily.edmonds@duke.edu | |
Contact: Patty Davis, RN 919-668-1026 davis043@mc.duke.edu | |
Principal Investigator: David A. Rizzieri, MD |
Principal Investigator: | David A Rizzieri, MD | Duke University |
Responsible Party: | Duke University Medical Center ( David Rizzieri, MD ) |
Study ID Numbers: | 8662 |
Study First Received: | July 30, 2007 |
Last Updated: | August 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00510289 |
Health Authority: | United States: Institutional Review Board |
Sorafenib Myelodysplastic Syndromes MDS |
Myelodysplastic syndromes Precancerous Conditions Hematologic Diseases Chronic myelomonocytic leukemia Leukemia, Myelomonocytic, Chronic Myelodysplastic Syndromes Myelodysplasia Myeloproliferative Disorders |
Leukemia, Myeloid Myelodysplastic myeloproliferative disease Leukemia Preleukemia Myelodysplastic-Myeloproliferative Diseases Bone Marrow Diseases Sorafenib |
Neoplasms Pathologic Processes Disease Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Syndrome Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |