A Study Evaluating CPI-1205 in Patients With B-Cell Lymphomas
A Study Evaluating CPI-1205 in Patients With B-Cell Lymphomas
First in human, open-label, sequential dose escalation and expansion study of CPI-1205 in
 patients with progressive B-cell lymphomas. CPI-1205 is a small molecule inhibitor of EZH2.
Inclusion Criteria:

 Adults (aged ≥ 18 years)

 Histologically confirmed diagnosis of a B-cell lymphoma that has progressed in spite of
 prior treatment, and for which additional effective standard therapy is not available

 Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

 Adequate hematological, renal, hepatic, and coagulation laboratory assessments

 Must give written informed consent to participate in this study before the performance of
 any study-related procedure

 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