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



Status:Active, not recruiting
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:March 2015
End Date:January 2019

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A Phase 1 Study of CPI-1205, a Small Molecule Inhibitor of EZH2, 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
We found this trial at
6
sites
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Jeremy Abramson, MD
Phone: 617-724-4000
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Columbus, Ohio 43210
Principal Investigator: Kami Maddocks, MD
Phone: 614-293-9627
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Columbus, OH
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Hackensack, New Jersey 07601
Principal Investigator: Andre Goy, MD
Phone: 551-996-5168
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Hackensack, NJ
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Lafayette, Indiana 47905
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Lafayette, IN
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3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Principal Investigator: Ian Flinn, MD, PhD
Phone: 615-339-4214
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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Nashville, TN
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Principal Investigator: Matthew Lunning, MD
Phone: 402-559-5166
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Omaha, NE
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