A Study Evaluating CPI-1205 in Patients With B-Cell Lymphomas

Exclusion Criteria

• •A primary lymphoma of the central nervous system (CNS) or known lymphomatous involvement of the CNS
• •Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of CPI-1205, including any unresolved nausea, vomiting, or diarrhea that is CTCAE grade \>1
• •Treatment with proton pump inhibitors, H2 antagonists, or antacids
• •Achlorhydria, either documented or suspected on the basis of an associated disease (e.g., pernicious anemia, atrophic gastritis, or certain gastric surgical procedures)
• •Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
• •Acute myocardial infarction or angina pectoris ≤ 6 months prior to starting study drug
• •New York Heart Association Class III or IV congestive heart failure
• •QTcF \> 470 msec on the screening ECG
• •Uncontrolled cardiac arrhythmia (patients with rate-controlled atrial fibrillation are not excluded)
• •A past medical history of other clinically significant cardiovascular disease (e.g., uncontrolled hypertension, history of labile hypertension or history of poor compliance with an antihypertensive regimen)
• •Any other concurrent severe and/or uncontrolled concomitant medical condition that could compromise participation in the study (e.g., clinically significant pulmonary disease, clinically significant neurological disorder, active or uncontrolled infection)
• •Systemic anti-cancer treatment or radiotherapy less than 2 weeks before the first dose of CPI 1205
• •Radioimmunotherapy (e.g., 131I-tositumomab, 90Y-ibritumomab tiuxetan) less than 6 weeks before the first dose of CPI-1205
• •Treatment with an investigational small molecule less than 2 weeks before the first dose of CPI-1205.
• •Treatment with a therapeutic antibody less than 4 weeks before the first dose of CPI-1205.
• •Treatment with medications that are strong inhibitors of CYP3A4
• •Treatment with medications that are inducers of CYP3A4 enzymes
• •Treatment with medications that are known to carry a risk of Torsades de Pointes
• •Pregnant or lactating women
• •Women of child bearing potential and men with reproductive potential, if they are unwilling to use adequate contraception while on study therapy and for 3 months thereafter
• •Patients unwilling or unable to comply with this study protocol