Combination of Sorafenib and Vorinostat in Poor-risk Acute Myelogenous Leukemia (AML) and High Risk Myelodysplastic Syndrome (MDS)
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.
Leukemia, Myeloid, Acute
Leukemia, Promyelocytic, Acute
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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)|
- Determine the maximum tolerated dose of a combination of Sorafenib and Vorinostat administered to patients with poor-risk AML, or MDS with >10% blasts. [ Time Frame: Baseline through cycle 3 ] [ Designated as safety issue: Yes ]
- Evaluate response and the duration of response to this combination targeted therapy [ Time Frame: Baseline through Cycle 3 ] [ Designated as safety issue: No ]
- Evaluate the toxicity of the combination of Sorafenib and Vorinostat in patients receiving this therapy [ Time Frame: Baseline through Cycle 3 ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2009|
|Estimated Study Completion Date:||April 2013|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
This is a single-arm, non-randomized feasibility and safety Phase I trial of a combination of Sorafenib and Vorinostat, both administered orally.
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00875745
|United States, Indiana|
|Indiana University Melvin and Bren Simon Cancer Center|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Hamid Sayar, MD||Indiana University Melvin and Bren Simon Cancer Center|