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TERMINATED
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

2026-07-01

Last Updated

2026-10-08

Healthy Volunteers

No

Interventions

DRUG

Tolinapant

Capsule for oral administration

DRUG

Decitabine + Cedazuridine

Tablet for oral administration

Locations (19)

University of Colorado Anschutz Medical Campus Site #118

Aurora, Colorado, United States

Moffitt Cancer Center Site #157

Tampa, Florida, United States

Winship Cancer Institute of Emory University

Atlanta, Georgia, 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

Concord Hospital

Concord, New South Wales, Australia

Monash Medical Center

Melbourne, Victoria, Australia

Institut Bergonié Site#553

Bordeaux, France

Institut Paoli-Calmettes

Marseille, France

U.O.C. di Ematologia Pad. 8IRCCS Azienda OspedalieroUniversitaria di Bologna Site#651

Bologna, Italy

Fondazione IRCCS San Gerardo dei Tintori Site #655

Monza, Italy

Ośrodek Badań Klinicznych Wczesnych Faz - Uniwersyteckie Centrum Kliniczne w Gdańsku

Gdansk, Pomeranian Voivodeship, Poland

Hospital Universitario Virgen del Rocío

Seville, Andalusia, 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