Clinical trial NCT00357162 (phase 2, status: completed)
Conditions: de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes
ICD codes: D46.Z, D46.9, C94.6, D46.C, D46.Z, D46.9, C94.6, D46.C, D46.Z, D46.9, C94.6, D46.C
Drugs: belinostat
SMILES: ONC(=O)\C=C\C1=CC=CC(=C1)S(=O)(=O)NC1=CC=CC=C1
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed myelodysplastic syndromes (MDS)

               -  De novo or secondary MDS

          -  Patients with < 5 % bone marrow blasts must meet ≥ 1 of the following criteria:

               -  Symptomatic anemia with either hemoglobin < 10.0 g/dL or required RBC
                  transfusions within the past 3 months

               -  Thrombocytopenia with ≥ 2 platelet counts < 50,000/mm³ or significant hemorrhage
                  requiring platelet transfusions

               -  Neutropenia with ≥ 2 absolute neutrophil counts < 1,000/mm³

          -  No acute myeloid leukemia (≥ 20% bone marrow blasts)

          -  ECOG performance status 0-2

          -  Life expectancy > 12 weeks

          -  Bilirubin ≤ 1.5 times upper limit of normal (ULN)

          -  AST ≤ 2 times ULN

          -  Creatinine ≤ 2.0 mg/dL

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No history of allergic reactions attributed to compounds of similar chemical or
             biologic composition to PXD101

          -  No HIV positivity

          -  QTc interval ≤ 500 msec

          -  No long QT syndrome

          -  No significant cardiovascular disease, including any of the following:

               -  Unstable angina pectoris

               -  Uncontrolled hypertension

               -  Congestive heart failure related to primary cardiac disease

               -  Condition requiring anti-arrhythmic therapy

               -  Ischemic or severe valvular heart disease

               -  Myocardial infarction within the past 6 months

          -  No other uncontrolled serious medical condition (e.g., cardiac arrhythmias or
             diabetes)

          -  Recovered from prior therapy

          -  No more than 2 prior therapies for MDS

               -  Prior hematopoietic growth factors, androgens, and other supportive care agents
                  allowed and are not considered in the prior therapy total

          -  No prior allogeneic stem cell transplantation

          -  More than 4 weeks since prior radiotherapy or chemotherapy (6 weeks for nitrosoureas
             or mitomycin C)

          -  No prior histone deacetylase (HDAC) inhibitors for treatment of MDS

          -  More than 2 weeks since prior valproic acid or other HDAC inhibitors

          -  No other concurrent investigational agents

          -  No concurrent medication that may cause torsades depointes, including any of the
             following:

               -  Disopyramide

               -  Dofetilide

               -  Ibutilide

               -  Procainamide

               -  Quinidine

               -  Sotalol

               -  Bepridil

               -  Methadone

               -  Amiodarone hydrochloride

               -  Arsenic trioxide

               -  Cisapride

               -  Calcium-channel blockers (e.g., lidoflazine)

               -  Anti-infective agents (i.e., clarithromycin, erythromycin, halofantrine,
                  pentamidine, or sparfloxacin)

               -  Domperidone or droperidol

               -  Antipsychotic agents (i.e., chlorpromazine, haloperidol, mesoridazine,
                  thioridazine, or pimozide)