A Study Evaluating CPI-1205 in Patients With B-Cell Lymphomas
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02395601 |
Recruitment Status :
Completed
First Posted : March 23, 2015
Last Update Posted : May 18, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
B-Cell Lymphoma | Drug: CPI-1205 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 41 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1 Study of CPI-1205, a Small Molecule Inhibitor of EZH2, in Patients With B-Cell Lymphomas |
Study Start Date : | March 2015 |
Actual Primary Completion Date : | December 2018 |
Actual Study Completion Date : | December 2018 |
Arm | Intervention/treatment |
---|---|
Experimental: CPI-1205 |
Drug: CPI-1205
Small molecule inhibitor of the enzyme EZH2 |
- Frequency of Dose-limiting toxicities (DLTs) [ Time Frame: DLTs asessed during Cycle 1 (first 28 days on study) ]Frequency of dose-limiting toxicities (DLTs) associated with CPI-1205 administration during the first cycle (first 28 days) of treatment
- Frequency of adverse events [ Time Frame: Assessed from Day 1 of Cycle 1 through 30 days after patient's last dose of study drug ]Safety and tolerability of CPI-1205 as assessed by: frequency of adverse events and serious adverse events; changes in hematology and clinical chemistry values; changes in physical examination, vital signs, electrocardiogram, and ECOG score
- Pharmacokinetic parameters of CPI-1205: AUC(0-t), AUC(0-inf), AUCtau,ss, Tmax, Cmax, Ctrough, T1/2, Vd/F, CL/F [ Time Frame: Assessed during cycle 1 (first 28 days on study); and on cycle 2, day 1 ]
- Pharmacodynamic effects of CPI-1205 in lymphoma tissue: changes in levels of the trimethylated form of lysine residue 27 on histone 3; changes in the expression of genes whose transcription may be altered by EZH2 inhibition [ Time Frame: Assessed during cycle 1 (first 28 days on study) ]
- Pharmacodynamic effects of CPI-1205 in bone marrow and in skin: changes in global levels of the trimethylated form of lysine residue 27 on histone 3 (H3K27me3) [ Time Frame: Assessed during cycle 1 (first 28 days on study) ]
- Disease response assessment will be performed using the 2014 Lugano Response Criteria for Hodgkin and Non-Hodgkin Lymphoma [ Time Frame: After every 2 cycles of treatment for the first 6 cycles, and after every 4 cycles thereafter ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02395601
United States, Indiana | |
Horizon Oncology Center | |
Lafayette, Indiana, United States, 47905 | |
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
United States, Nebraska | |
University of Nebraska Medical Center | |
Omaha, Nebraska, United States, 68198 | |
United States, New Jersey | |
John Theurer Cancer Center | |
Hackensack, New Jersey, United States, 07601 | |
United States, Ohio | |
The Ohio State University James Cancer Hospital | |
Columbus, Ohio, United States, 43210 | |
United States, Tennessee | |
Sarah Cannon Research Institute | |
Nashville, Tennessee, United States, 37203 |
Responsible Party: | Constellation Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT02395601 |
Other Study ID Numbers: |
1205-01 |
First Posted: | March 23, 2015 Key Record Dates |
Last Update Posted: | May 18, 2022 |
Last Verified: | May 2022 |
B-Cell Lymphoma EZH2 Inhibitor Phase 1 |
Lymphoma Lymphoma, B-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases |
Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin (R)-N-((4-methoxy-6-methyl-2-oxo-1,2-dihydropyridin-3-yl)methyl)-2-methyl-1-(1-(1-(2,2,2-trifluoroethyl)piperidin-4-yl)ethyl)-1H-indole-3-carboxamide Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |