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Sponsors and Collaborators: |
Indiana University School of Medicine Bayer |
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Information provided by: | Indiana University |
ClinicalTrials.gov Identifier: | NCT00875745 |
The purpose of this study is to test the safety of sorafenib and vorinostat when given together to see what effects (good and bad) it has on the patient and their acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). This study is also being done to find the highest dose of sorafenib and vorinostat that can be given together without causing severe side effects.
Condition | Intervention | Phase |
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Leukemia, Myeloid, Acute Leukemia, Promyelocytic, Acute Myelodysplastic Syndromes |
Drug: Sorafenib-Vorinostat |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety Study |
Official Title: | Phase I, Open-Label, Dose-Escalation Study of the Combination of Sorafenib and Vorinostat in Poor-Risk Acute Myelogenous Leukemia (AML) and High Risk Myelodysplastic Syndrome (MDS) |
Estimated Enrollment: | 27 |
Study Start Date: | April 2009 |
Estimated Study Completion Date: | April 2014 |
Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Sorafenib-Vorinostat: Experimental
This is a single-arm, non-randomized feasibility and safety Phase I trial of a combination of Sorafenib and Vorinostat, both administered orally.
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Drug: Sorafenib-Vorinostat
Patients will be entered in successive cohorts. The first cohort will receive Sorafenib at 400 mg bid (800 mg daily) and Vorinostat at 100 mg bid (200 mg daily).
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The patients must have one of the following criteria:
Exclusion Criteria:
Contact: Mary Cangany, RN | 317-274-2178 | mcangany@iupui.edu |
Contact: Hamid Sayar, MD | 317-274-7126 | ssayar@iupui.edu |
United States, Indiana | |
Indiana University Melvin and Bren Simon Cancer Center | Recruiting |
Indianapolis, Indiana, United States, 46202 | |
Contact: Mary Cangany, RN 317-274-2178 mcangany@iupui.edu | |
Contact: Hamid Sayar, MD 317-274-7126 ssayar@iupui.edu | |
Principal Investigator: Hamid Sayar, MD |
Principal Investigator: | Hamid Sayar, MD | Indiana University Melvin and Bren Simon Cancer Center |
Responsible Party: | Indiana University Melvin and Bren Simon Cancer Center ( Hamid Sayar, MD/ Principal Investigator ) |
Study ID Numbers: | 0902-08; IUCRO-0234 |
Study First Received: | April 2, 2009 |
Last Updated: | April 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00875745 History of Changes |
Health Authority: | United States: Institutional Review Board |
Anticarcinogenic Agents Anti-Inflammatory Agents Precancerous Conditions Hematologic Diseases Myelodysplastic Syndromes Vorinostat Leukemia, Myeloid Leukemia, Myeloid, Acute Protein Kinase Inhibitors Leukemia Preleukemia |
Acute Myelocytic Leukemia Acute Myeloid Leukemia, Adult Analgesics, Non-Narcotic Leukemia, Promyelocytic, Acute Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Bone Marrow Diseases Sorafenib |
Anticarcinogenic Agents Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Precancerous Conditions Antineoplastic Agents Physiological Effects of Drugs Leukemia, Myeloid, Acute Protein Kinase Inhibitors Leukemia Preleukemia Pathologic Processes Sensory System Agents Syndrome Therapeutic Uses Leukemia, Promyelocytic, Acute |
Anti-Inflammatory Agents, Non-Steroidal Analgesics Disease Neoplasms by Histologic Type Hematologic Diseases Myelodysplastic Syndromes Vorinostat Enzyme Inhibitors Leukemia, Myeloid Protective Agents Pharmacologic Actions Neoplasms Analgesics, Non-Narcotic Peripheral Nervous System Agents Antirheumatic Agents |