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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
2026-07-01
Last Updated
2026-10-08
Healthy Volunteers
No
Interventions
Tolinapant
Capsule for oral administration
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