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A Study of Tolinapant in Combination With Oral Decitabine/Cedazuridine and Oral Decitabine/Cedazuridine Alone in Participants With Relapsed/Refractory Peripheral T-cell Lymphoma (R/R PTCL)
Sponsor: Taiho Oncology, Inc.
Summary
The primary purpose of the study is to assess safety, and to identify the recommended phase 2 dose (RP2D) of tolinapant in combination with oral decitabine/cedazuridine in Phase 1 and to assess preliminary efficacy as determined by overall response rate (ORR) in Phase 2. As no safe and tolerable dosing for the combination of tolinapant and decitabine/cedazuridine was identified based on protocol defined criteria, Sponsor decided to halt recruitment and to not conduct Phase 2 of the study.
Official title: A Phase 1-2, Open-Label Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Activity of Tolinapant in Combination With Oral Decitabine/Cedazuridine and Oral Decitabine/Cedazuridine Alone in Subjects With Relapsed/Refractory Peripheral T-cell Lymphoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
33
Start Date
2023-02-22
Completion Date
2026-03-31
Last Updated
2026-02-23
Healthy Volunteers
No
Interventions
Tolinapant
Capsule for oral administration
Decitabine + Cedazuridine
Tablet for oral administration
Locations (46)
City of Hope Site #151
Duarte, California, United States
University of Califonia, Los Angeles
Los Angeles, California, United States
Stanford University
Stanford, California, United States
University of Colorado Anschutz Medical Campus Site #118
Aurora, Colorado, United States
Yale Cancer Center Site #109
New Haven, Connecticut, United States
Moffitt Cancer Center Site #157
Tampa, Florida, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
Johns Hopkins University
Baltimore, Maryland, United States
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute Site#159
Detroit, Michigan, United States
Rochester Skin Lymphoma Medical Group, PLLC Site #147
Fairport, New York, United States
NYU Langone Laura and Isaac Perlmutter Cancer Center Site #153
New York, New York, United States
University of Pennsylvania Site# 160
Philadelphia, Pennsylvania, United States
The University of Texas MD Anderson Cancer Center Site #101
Houston, Texas, United States
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Concord Hospital
Concord, New South Wales, Australia
Monash Medical Center
Melbourne, Victoria, Australia
Linear Clinical Research Site #834
Nedlands, Australia
Hôpital Bretonneau
Tours, Indre-et-Loire, France
Centre Henri Becquerel
Rouen, Seine-Maritime, France
Institut Bergonié Site#553
Bordeaux, France
Institut Paoli-Calmettes
Marseille, France
CHU Saint-Eloi Site#556
Montpellier, France
Centre Antoine Lacassagne
Nice, France
AP-HP Pitie Saltpetriere Site# 552
Paris, France
Institut Gustave Roussy
Villejuif, France
Ospedale Santa Maria delle Croci di Ravenna
Ravenna, Emilia-Romagna, Italy
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST
Meldola, Forli-Cesena, Italy
U.O.C. di Ematologia Pad. 8IRCCS Azienda OspedalieroUniversitaria di Bologna Site#651
Bologna, Italy
Azienda Socio Sanitaria Territoriale (ASST) degli Spedali Civili di Brescia Site#650
Brescia, Italy
Istituto Europeo di Oncologia Site#652
Milan, Italy
Fondazione IRCCS San Gerardo dei Tintori Site #655
Monza, Italy
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy
Warsaw, Masovia, Poland
Ośrodek Badań Klinicznych Wczesnych Faz - Uniwersyteckie Centrum Kliniczne w Gdańsku
Gdansk, Pomeranian Voivodeship, Poland
Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi
Lodz, Łódź Voivodeship, Poland
Hospital Universitario Virgen del Rocío
Seville, Andalusia, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, Spain
Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)
Barcelona, Catalonia, Spain
Hospital del Mar Site #704
Barcelona, Spain
Hospital Universitario Fundación Jiménez Díaz Site #703
Madrid, Spain
Hospital Universitario 12 de Octubre Site#710
Madrid, Spain
Hospital Universitario Marqués de Valdecilla Site#711
Santander, Spain
Guy's and Saint Thomas' NHS Foundation Trust
London, England, United Kingdom
University College London Hospitals NHS Foundation Trust
London, England, United Kingdom
The Christie NHS Foundation Trust
Manchester, England, United Kingdom