NCT05403450

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)

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Taiho Oncology, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Relapsed/Refractory Peripheral T-cell Lymphoma

Interventions

Type	Name	Description
DRUG	Tolinapant	Capsule for oral administration
DRUG	Decitabine + Cedazuridine	Tablet for oral administration

Timeline

• Start date: 2023-02-22
• Primary completion: 2024-12-16
• Completion: 2026-03-31
• First posted: 2022-06-03
• Last updated: 2026-02-23

Locations

46 sites across 7 countries: United States, Australia, France, Italy, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated drug study