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ACTIVE NOT RECRUITING
NCT05403450
PHASE1

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.

View on ClinicalTrials.gov

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

DRUG

Tolinapant

Capsule for oral administration

DRUG

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