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NCT05403450 · ClinicalTrials.gov registry record · Phase 1
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 study of Relapsed/Refractory Peripheral T-cell Lymphoma, sponsored by Taiho Oncology.
- Active
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
- 20
- Study locations
NCT05403450: Active Phase 1 study of Relapsed/Refractory Peripheral T-cell Lymphoma, sponsored by Taiho Oncology.
NCT05403450 is a Phase 1 study of Relapsed/Refractory Peripheral T-cell Lymphoma that is active but no longer recruiting, run by Taiho Oncology. The registered enrollment target is 33 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05403450, a Phase 1 study of Relapsed/Refractory Peripheral T-cell Lymphoma, is active but no longer recruiting, sponsored by Taiho Oncology.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
This will be evaluated by looking at the number of participants with treatment-related adverse events, serious adverse events (SAEs), and dose-limiting toxicities (DLTs), which are medical problems severe enough to stop study doctors from increasing a treatment dose.
Conditions Studied
Interventions
- DRUG Tolinapant
- DRUG Decitabine + Cedazuridine
Study Locations (20)
California
- City of Hope Site #151 - Duarte
- University of Califonia, Los Angeles - Los Angeles
- Stanford University - Stanford
Michigan
- University of Michigan Rogel Cancer Center - Ann Arbor
- Barbara Ann Karmanos Cancer Institute Site#159 - Detroit
New York
- Rochester Skin Lymphoma Medical Group, PLLC Site #147 - Fairport
- NYU Langone Laura and Isaac Perlmutter Cancer Center Site #153 - New York
Colorado
- University of Colorado Anschutz Medical Campus Site #118 - Aurora
Connecticut
- Yale Cancer Center Site #109 - New Haven
Florida
- Moffitt Cancer Center Site #157 - Tampa
Georgia
- Winship Cancer Institute of Emory University - Atlanta
Maryland
- Johns Hopkins University - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2023-02-22 |
| Est. Completion | 2026-03-31 |
| Phase | Phase 1 |
What the registry record for NCT05403450 still lists
NCT05403450 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower).
The record links to 1 condition, with Relapsed/Refractory Peripheral T-cell Lymphoma appearing as the primary indexed condition, and to 2 interventions - of which Tolinapant is the first listed.
NCT05403450 names 20 study sites across 16 states, led by California, Michigan, New York.
Frequently Asked Questions
What is clinical trial NCT05403450 about?
NCT05403450 is a clinical study titled "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)". 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 do...
What is the current status of trial NCT05403450?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2023-02-22. Estimated completion is 2026-03-31.
What conditions does trial NCT05403450 study?
This clinical trial studies the following conditions: Relapsed/Refractory Peripheral T-cell Lymphoma.
What interventions are being tested in trial NCT05403450?
The interventions under investigation include: Tolinapant (DRUG), Decitabine + Cedazuridine (DRUG).
Who is sponsoring clinical trial NCT05403450?
This trial is sponsored by Taiho Oncology, which has 52 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05403450 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05403450's enrollment target sits among peer trials
33 1280th of 2000 higher than 705 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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