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)
Public ClinicalTrials.gov record NCT05403450. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05403450
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 33 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 21, 2023
- Primary completion
- Dec 15, 2024
- Completion
- Jun 30, 2026
- Last update posted
- Jul 8, 2026
2023 – 2026
United States locations
- U.S. sites
- 16
- U.S. states
- 12
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope Site #151 | Duarte | California | 91010 | — |
| University of Califonia, Los Angeles | Los Angeles | California | 90095 | — |
| Stanford University | Stanford | California | 94305 | — |
| University of Colorado Anschutz Medical Campus Site #118 | Aurora | Colorado | 80045 | — |
| Yale Cancer Center Site #109 | New Haven | Connecticut | 06511 | — |
| Moffitt Cancer Center Site #157 | Tampa | Florida | 33612 | — |
| Winship Cancer Institute of Emory University | Atlanta | Georgia | 30322 | — |
| Johns Hopkins University | Baltimore | Maryland | 21287 | — |
| University of Michigan Rogel Cancer Center | Ann Harbor | Michigan | 48109 | — |
| Barbara Ann Karmanos Cancer Institute Site#159 | Detroit | Michigan | 48201 | — |
| Rochester Skin Lymphoma Medical Group, PLLC Site #147 | Fairport | New York | 14450 | — |
| NYU Langone Laura and Isaac Perlmutter Cancer Center Site #153 | New York | New York | 10016 | — |
| University of Pennsylvania Site# 160 | Philadelphia | Pennsylvania | 19104 | — |
| The University of Texas MD Anderson Cancer Center Site #101 | Houston | Texas | 77030 | — |
| University of Virginia Comprehensive Cancer Center | Charlottesville | Virginia | 22908 | — |
| Fred Hutchinson Cancer Center | Seattle | Washington | 98109 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 30 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05403450, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 8, 2026 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05403450 live on ClinicalTrials.gov.