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

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Disease Information

Descriptive Information
Brief Title † A Study Evaluating CPI-1205 in Patients With B-Cell Lymphomas
Official Title † A Phase 1 Study of CPI-1205, a Small Molecule Inhibitor of EZH2, in Patients With B-Cell Lymphomas
Brief 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.
Detailed Description
Study Phase Phase 1
Study Type † Interventional
Study Design † Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary Outcome Measure † Frequency of Dose-limiting toxicities (DLTs)
Secondary Outcome Measure † Frequency of adverse events
Condition † B-Cell Lymphoma
Intervention † DrugCPI-1205
Study Arms / Comparison Groups CPI-1205
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 41
Start Date † March 2015
Completion Date January 2019
Primary Completion Date October 2018
Eligibility Criteria † 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
Gender Both
Ages 18 Years - N/A
Accepts Healthy Volunteers No
Contacts †† Debbie Johnson, 617 714 0531, debbie.johnson@constellationpharma.com
Location Countries † United States
Administrative Information
NCT ID † NCT02395601
Organization ID 1205-01
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † Constellation Pharmaceuticals
Collaborators ††
Investigators † Study Director: Debbie Johnson, Constellation Pharmaceuticals
Information Provided By
Verification Date November 2016
First Received Date † March 10, 2015
Last Updated Date November 22, 2016
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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