Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Signed, informed consent
Confirmed malignant haematological disease or lymphoid malignancy refractory to standard therapy or for which no standard therapy exists, including acute leukemias, MDS, CML, CLL, CMML, multiple myeloma and Non-Hodgkin's Lymphomas/Hodgkin's disease
Patients shall have recovered from all acute adverse effects of prior therapies, with the exception of alopecia and grade 1 neuropathy where recovery is not required

Adequate bone marrow, hepatic and renal function including the following:

Patients with high blast counts can be included if they can be controlled by the use of hydroxyurea (500 mg -3,000 mg daily).
Total bilirubin ≤ 1.5 x upper normal limit, excluding cases where elevated bilirubin can be attributed to Gilbert's Syndrome
AST (SGOT), ALT (SGPT) ≤ 2.5 x upper normal limit
Creatinine ≤ 1.5 x upper normal limit
Age ≥ 18 years
Performance status (PS) ≤ 2 - Eastern Cooperative Oncology Group (ECOG) scale
Estimated life expectancy greater than 3 months
Female patients with reproductive potential must have a negative serum pregnancy test within 7 days prior to start of trial. Both women and men must agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months after discontinuation of treatment.

Exclusion Criteria:

Patients receiving anti-cancer therapy or use of other investigational agents within 21 days prior to trial entry (or a longer period depending on the defined characteristics of the agents used. Bisphosphonates for bone disease and corticosteroids are permitted provided the dose does not change during the trial. Patients must have recovered from all transient toxicity induced by prior therapy
Patients with co-existing active infection, graft versus host disease or serious concurrent illness
Patients who have failed to recover from or after a bone marrow transplantation or haematopoietic stem cell transplantation
The following diseases are excluded: Burkitt's lymphoma, primary effusion lymphoma, precursor B-cell lymphoblastic lymphoma, symptomatic central nervous system (CNS) lymphoma, CML blast crisis

Patients with significant cardiovascular disease as defined by:

history of congestive heart failure requiring therapy
history of angina pectoris requiring treatment or myocardial infarction within 6 months prior to trial entry
presence of severe valvular heart disease
presence of an atrial or ventricular arrhythmia requiring treatment
Left Ventricular Ejection Fraction (LVEF) below the normal range at the study centre
Uncontrolled hypertension
A history of abnormal QTc intervals or an average QTc interval at screening ≥450 msec
Any medical or other condition that in the investigator's opinion renders the patient unsuitable for this study due to unacceptable risk
Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary studies
Gastrointestinal disorders that may interfere with absorption of the study drug
Patients with known brain tumours or metastases
More than 6 prior chemotherapy regimens
Patients requiring growth factor support (erythropoietin, Granulocyte/monocyte Colony Stimulating Factor (GM/CSF), etc)
Patients requiring palliative radiotherapy within the last 4 weeks prior to study entry
Uncontrolled hypercalcaemia (CTCAE v3 grade 2 or higher)
Abnormal plasma potassium or magnesium levels (Common Terminology Criteria for Adverse Events (CTCAE) v3 grade 3 or greater) despite therapy
Pregnant or breast-feeding women