| Exclusion Criteria: | 1) Patients with another active cancer (excluding basal cell carcinoma or cervical intraepithelial neoplasia [CIN / cervical carcinoma in situ] or melanoma in situ). Prior history of other cancer is allowed, as long as there is no active disease within the prior 5 years.
2) Prior allogeneic stem cell transplantation requiring active immunosuppressive therapy within 3 months of registration or with evidence of active graft versus host disease (GVHD)
3) Pregnant or lactating women. Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test documented within 7 days prior to start of study drug.
4) Women with child bearing potential (WOCBP) and men whose partners are WOCBP must use an acceptable method of contraception while enrolled on this study, and for a period of 3 months following the last dose of study drug. An example of an acceptable form of contraception is a double barrier method, such as condom with diaphragm.
5) Patients with uncontrolled intercurrent illness, active or uncontrolled infections or a fever >38.5 degrees C that has not been evaluated for infection on the day of scheduled dosing. Patients with documented history of tumor fever are acceptable, provided acute or chronic infection has been excluded as possible cause of the fever.
6) Patients who have been treated with any investigational drug within 28 days prior to the first dose of study drug, or who are receiving concurrent treatment with other experimental drugs or anti-cancer therapy.
7) Prior treatment with HDAC inhibitors (e.g. valproic acid, Zolinaz (SAHA), romidepsin (Istodax),and experimental compounds such as MethylGene's MGCD0103 and Novartis' LBH589).
8) History of pericarditis or pericardial effusion that had required medical or surgical intervention in the last 6 months, or myocardial infarction or arterial thromboembolic events within 6 months, or experiencing severe or unstable angina, or New York Heart Association (NYHA) Class III or IV disease, or a QTc interval > 0.47 seconds.
9) Known HIV or active Hepatitis B or C as evidenced by laboratory abnormalities in addition to positive serology. Testing is not required for patients not suspected of having these conditions.
10) Known HIV or a history of active Hepatitis B or C. Testing is not required for patients not suspected of having these conditions
11) Active central nervous system lymphoma and lymphoma with leptomeningeal involvement
12) Any condition (e.g., known or suspected poor compliance, psychological instability, geographical location, etc) that, in the judgment of the investigator, may affect the patient's ability to sign the informed consent and comply with study procedures
13) Any condition that will put the patient at undue risk or discomfort as a result of adherence to study procedures
14) History of gastrointestinal disorders (medical disorder or extensive surgery) that could interfere with absorption of study drug. |