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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 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. The trial reports 20 study locations across 16 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05403450
The ClinicalTrials.gov registry entry for NCT05403450 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Taiho Oncology, which has 52 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 16 distinct geographic areas - top geographies include 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.
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