Patient case: 58-year-old female with endometrial cancer; genetic feature: PIK3R1

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

Summary: 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.


Eligibility: 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

Relevance to patient case: not relevant