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

Completed · Phase 1

Conditions studied: B-Cell Lymphoma

In brief

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.

Key facts

Study ID

NCT02395601

Run by

Constellation Pharmaceuticals

People needed

41

Starts

2015-03-01

Expected to finish

2018-12-01

Last updated by the study team

2022-05-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Horizon Oncology Center — Lafayette, Indiana, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• John Theurer Cancer Center — Hackensack, New Jersey, United States
• The Ohio State University James Cancer Hospital — Columbus, Ohio, United States
• Sarah Cannon Research Institute — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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