| Exclusion Criteria: | 1) Patients with known impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of PKC412.
2) Female patients who are pregnant or breast-feeding or adults of reproductive potential not employing an effective method of birth control. Barrier contraceptives must be used throughout the study in both sexes. Women of childbearing potential must have a negative serum pregnancy test 48 hours prior to administration of PKC412.
3) Patients with any other known disease (except carcinoma in-situ) concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, cardiovascular disease including congestive heart failure, myocardial infarction within 6 months and poorly controlled hypertension, chronic renal disease, or active uncontrolled infection) which could compromise participation in the study.
4) Patients with a known confirmed diagnosis of HIV infection or active viral hepatitis.
5) Patients who have received any investigational agent within 30 days prior to Day 1.
6) Patients who have had any surgical procedure, excluding central venous catheter placement or other minor procedures (e.g. skin biopsy) within 14 days of Day 1.
7) Patients unwilling or unable to comply with the protocol.
8) Patients with an ejection fraction < 50% assessed by MUGA or ECHO scan within 14 days of Day 1.
9) Patients with known malignant disease of the central nervous system.
10) Patients with any pulmonary infiltrate known to be recent, and suspected to be of infectious origin. |