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Trial record 1 of 1 for:    0209-01
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A Study of CPI-0209 in Patients With Advanced Tumors

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04104776
Recruitment Status : Recruiting
First Posted : September 26, 2019
Last Update Posted : April 15, 2021
Information provided by (Responsible Party):
Constellation Pharmaceuticals

Brief Summary:
First-in-human, open-label, sequential dose escalation and expansion study of CPI-0209 in patients with advanced tumors alone and in combination with other therapies. CPI-0209 is a small molecule inhibitor of EZH2.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Diffuse Large B Cell Lymphoma Drug: CPI-0209 Drug: Irinotecan Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 284 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Study of CPI-0209 Monotherapy and in Combination With Other Therapy in Patients With Advanced Tumors
Actual Study Start Date : September 18, 2019
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : March 1, 2026

Arm Intervention/treatment
Experimental: Monotherapy
CPI-0209 will be dosed once per day orally in 28 day cycles
Drug: CPI-0209
CPI-0209 alone

Experimental: Combination Therapy
CPI-0209 will be dosed once per day orally in 21 day cycles. Irinotecan iv will be dosed on day 1 of every cycle.
Drug: CPI-0209
CPI-0209 alone

Drug: Irinotecan
CPI-0209 in combination with irinotecan

Primary Outcome Measures :
  1. Phase 1: Frequency of Dose-limiting toxicities (DLTs) [ Time Frame: DLTs assessed during Cycle 1 (first 28 days on study for monotherapy and first 21 days for combination therapy) ]
    The maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of CPI-0209 as monotherapy and in combination with irinotecan in patients with advanced tumors

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 18 years or older
  • Life expectancy of ≥ 12 weeks
  • Recovered to baseline or Grade ≤ 1 severity from toxicity related to prior treatments, unless AEs are clinically non-significant and/or stable on supportive therapy
  • ECOG 0-1
  • Adequate bone marrow function
  • Adequate renal function
  • Adequate liver function

Exclusion Criteria:

  • Previous solid organ or hematopoietic cell transplant
  • Known brain metatstases
  • Prior EZH2 inhibitor
  • Concomitant medication(s) or food or beverage that are moderate or strong CYP3A inducers or inhibitors within 2 weeks prior to the first dose of study drug
  • Clinically significant cardiovascular disease
  • Major surgery within 4 weeks
  • GI disorders affecting absorption
  • Uncontrolled infection
  • Suspected pneumonitis or interstitial lung disease
  • Known additional malignancy that is active and/or progressive requiring treatment
  • Known HIV or active hepatitis
  • Chronic liver disease
  • 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT04104776

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United States, Georgia
Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30322
Contact: Kelsey Gates    404-727-3547   
Principal Investigator: R. Donald Harvey, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Catie Elsier    617-643-0425   
Principal Investigator: Ryan Sullivan, MD         
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Paula Caras    617-632-5617    Paula_Caras@DFCI.HARVARD.EDU   
Principal Investigator: Khanh Do, MD         
United States, Michigan
START Midwest Recruiting
Grand Rapids, Michigan, United States, 49546
Contact: Shannon S Skibinski-Preston, MPH    616-954-5552   
Contact: Yvette Cole, RN    616-389-1652   
Principal Investigator: Nehal Lakhani, MD         
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Chelsea McCabe    551-996-4725   
Principal Investigator: Martin Gutierrez, MD         
United States, Texas
START San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Tiffany Lurati, RN    210-593-5290   
Contact: Carrie Choi, RN    210-593-2547   
Principal Investigator: Drew Rasco, MD         
United States, Virginia
University of Virginia Cancer Center Recruiting
Charlottesville, Virginia, United States, 22903
Contact: Anne Gabel    434-982-6657   
Principal Investigator: Linda Duska,, MD         
Sponsors and Collaborators
Constellation Pharmaceuticals
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Responsible Party: Constellation Pharmaceuticals Identifier: NCT04104776    
Other Study ID Numbers: 0209-01
First Posted: September 26, 2019    Key Record Dates
Last Update Posted: April 15, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma, Large B-Cell, Diffuse
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents