Spots Global Cancer Trial Database for A Study of CPI-0209 in Patients With Advanced Solid Tumors and Lymphomas
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Trial Identification
Brief Title: A Study of CPI-0209 in Patients With Advanced Solid Tumors and Lymphomas
Official Title: A Phase 1/2 Study of CPI-0209 in Patients With Advanced Solid Tumors and Lymphomas
Study ID: NCT04104776
Interventions
Study Description
Brief Summary: First-in-human, open-label, sequential dose escalation and expansion study of CPI-0209 in patients with advanced solid tumors and lymphomas. CPI-0209 is a small molecule inhibitor of EZH2.
Detailed Description: Emerging evidence suggests that EZH2 is overexpressed in many cancer types and has a pivotal role in disease progression. This is a Phase 1/2, open-label, multi-center, FIH study designed to evaluate the safety and tolerability and preliminary clinical activity of CPI-0209, an EZH2/1 inhibitor as monotherapy in patients with advanced solid tumors and lymphomas. Phase 1 is composed of a CPI-0209 Dose Escalation period in patients with advanced tumors and aims to determine maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of CPI-0209 as monotherapy in patients with advanced tumors. Phase 2 is planned to evaluate safety and tolerability and antitumor activity of CPI-0209 in six disease-specific cohorts (M1 to M6). Patients in Cohorts M1, M2, M3, M5, and M6 will be enrolled at 10 to 29 patients per cohort, using a Simon 2-stage design. Cohort M4 will enroll up to 20 patients with lymphoma in a single-stage. The primary aim of Phase 2 part of the study is to evaluate the antitumor activity of CPI-0209, and characterize the safety and tolerability of CPI-0209 as monotherapy in patients with selected tumors. In Phase 2, two additional doses are planned to be evaluated in cohorts M2 and M3 in 2 stages: Stage 2a and Stage 2b. In Stage 2a approximately 20 patients will be enrolled per cohort and will be randomized 1:1 to receive 2 prespecified dose levels of CPI-0209 once daily. When protocol criteria for initiating Stage 2b will be fulfilled after completion of Stage 2a, then Stage 2b will be opened for enrolment of additional 10 patients in one or both dose arms in each of the two cohorts. Thus, up to 40 patients per cohort (M2 and M3) could be enrolled.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Winship Cancer Institute of Emory University, Atlanta, Georgia, United States
University of Chicago Medical Center, Chicago, Illinois, United States
University of Maryland - Marlene and Stewart Greenebaum Cancer Center, Baltimore, Maryland, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
University of Michigan Hospital, Ann Arbor, Michigan, United States
South Texas Accelerated Research Therapeutics (Start) - Midwest Location, Grand Rapids, Michigan, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Montefiore Einstein Center for Cancer Care, Bronx, New York, United States
NYU Langone Medical Center - Laura and Isaac Perlmutter Cancer Center, New York, New York, United States
Weill Medical College of Cornell University, New York, New York, United States
University of Cincinnati Medical Center, Cincinnati, Ohio, United States
South Texas Accelerated Research Therapeutics, San Antonio, Texas, United States
University of Virginia Health System, Charlottesville, Virginia, United States
Swedish Cancer Institute, Seattle, Washington, United States
Fred Hutchinson Cancer, Seattle, Washington, United States
Bergonie Institute, Bordeaux, , France
Oscar Lambret Center, Lille, , France
Leon Berard Center, Lyon, , France
Hospital North, Nantes, , France
Nantes University Hospital Center - Hotel Dieu Hospital (Satellite), Nantes, , France
Nantes University Hospital Center - Hotel Dieu Hospital, Nantes, , France
Strasbourg Europe Institut of Cancerology, Strasbourg, , France
Gustave Roussy, Villejuif, , France
Irccs University Hospital of Bologna, Bologna, , Italy
Gruppo Humanitas - Humanitas Research Hospital - Cancer Center, Milan, , Italy
University Polyclinic Foundation "Agostino Gemelli" - IRCCS, Rome, , Italy
Gangnam Severance Hospital, Seoul, , Korea, Republic of
Polish Mother's Memorial Hospital-Research Institute, Lodz, , Poland
Medical Center Pratia Poznan, Skorzewo,, , Poland
Maria Sklodowska-Curie - National Research Institute of Oncology, Warsaw, , Poland
University Clinical Hospital of Salamanca, Salamanca, Castilla Y Leon, Spain
University Hospital Complex of Santiago (CHUS), Santiago De Compostela, Galicia, Spain
University Hospital Vall d'Hebron, Barcelona, , Spain
University Hospital of Girona Dr. Josep Trueta, Girona, , Spain
University Clinic of Navarra - Madrid, Madrid, , Spain
University Hospital 12 de Octubre, Madrid, , Spain
University Hospital Quiron Madrid, Madrid, , Spain
University Hospital Son Espases, Palma De Mallorca, , Spain
University Clinic of Navarra - Pamplona, Pamplona, , Spain
University Hospital Virgen del Rocio (HUVR), Seville, , Spain
Valencia Oncology Institute (IVO), Valencia, , Spain
Royal United Hospital, Bath, , United Kingdom
University Hospitals of Leicester NHS Trust, Leicester, , United Kingdom
The Christie NHS Foundation Trust, Department of Medical Oncology, Manchester, , United Kingdom
Royal Marsden Hospital - Sutton, Sutton, , United Kingdom
Musgrove Park Hospital, Taunton, , United Kingdom
Contact Details
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