| Exclusion Criteria: | 1) Patients with another active cancer (excluding basal cell carcinoma or cervical intraepithelial neoplasia (CIN / cervical in situ) or melanoma in situ). Prior history of cancer is allowed, as long as there is no active disease.
2) 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.
3) 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 study drug treatment. Patients unwilling or unable to follow this guideline will be excluded. An example of an acceptable form of contraception is a double barrier method, such as condom with diaphragm.
4) Patients with uncontrolled intercurrent illness, active or uncontrolled infections, or a fever >38.5°C (not due to tumor fever) on the day of scheduled dosing.
5) Patients with serious illnesses, medical conditions, or other medical history, including laboratory results, which, in the investigator's opinion, would be likely to interfere with a patient's participation in the study, or with the interpretation of the results.
6) Patients who have been treated with any investigational drug within 28 days prior to study initiation (an investigational drug is one for which there is no approved indication), or who are receiving concurrent treatment with other experimental drugs or anti-cancer therapy. Patients must have recovered from all transient toxicity induced by prior therapy.
7) Known hypersensitivity to HDAC inhibitors, and to any of the components of MGCD0103 (N-(2-Amino-phenyl)-4-[4-pyridin-3-yl-pyrimidin-2-ylamino)-methyl]-benzamide dihydrobromide, microcrystalline cellulose, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate (non-bovine).
8) Known human immunodeficiency virus (HIV) or active Hepatitis B or C. Testing is not required for patients not suspected of having these conditions. For patients with a history of Hepatitis B or C that is no longer active, the Investigator should contact MethylGene in advance to confirm patient's eligibility. The reason for this exclusion is concern for safety of patients with these infections. There are no data to date in these populations.
9) Central nervous system lymphoma and lymphoma involving the leptomeningeal area.
10) 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 undergo study procedures.
11) Any condition that will put the patient at undue risk or discomfort as a result of adherence to study procedures. For example, consider requirement to take MGCD0103 with a low-pH drink and recommendation to avoid agents that directly increase gastric-pH such as short acting antacids for 4 hours before and 1 hour after administration of MGCD0103. |