A Phase 1 interventional study of Tolinapant and Decitabine + Cedazuridine in Relapsed/Refractory Peripheral T-cell Lymphoma, sponsored by Taiho Oncology, Inc.. Terminated at 46 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-09.
Sponsored by Taiho Oncology, Inc. · Phase 1, Interventional, and Treatment
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.
604 studies on the registry are indexed under Lymphoma, T-Cell, Peripheral; 133 are open to participants now.
This study's enrollment of 33 is below the median of 38 across 526 interventional studies indexed under Lymphoma, T-Cell, Peripheral.
Browse Lymphoma, T-Cell, Peripheral studies →Taiho Oncology, Inc. is the lead sponsor of 62 studies on the registry; 8 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 13 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants must have histologically confirmed R/R PTCL (local pathology report) as defined by 2016 World Health Organization (WHO) classification. The following subtypes are eligible for the study:
Exclusion Criteria:
A history of, or at risk for, cardiac disease, as evidenced by 1 or more of the following conditions:
Prior anticancer treatments or therapies within the indicated time window before first dose of study treatment (tolinapant), as follows:
Anti-T-cell directed therapy:
Tolinapant, orally, once daily (QD) on Days 1 to 7 and 15 to 21 of each 28-day cycle in combination with oral decitabine/cedazuridine fixed-dose combination (FDC) tablet, QD on days determined by the Lead-in Phase during each 28-day cycle. The starting dose of tolinapant will be escalated stepwise in successive cohorts until the RP2D is determined. Based on RP2D and results determined from Phase 1 participants would receive tolinapant at the identified RP2D in combination with decitabine/cedazuridine, FDC tablet, orally, QD on days determined by the Lead-in Phase during each 28-day cycle in Phase 2.
Drug: Tolinapant · Drug: Decitabine + Cedazuridine
Decitabine/cedazuridine FDC tablet, orally, QD on days determined by the Lead-in Phase during each 28-day cycle.
Drug: Decitabine + Cedazuridine
Capsule for oral administration
Also known as: ASTX660
Tablet for oral administration
Also known as: ASTX727
Phase 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Dose Limiting Toxicities (DLTs)
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.
Time frame: Up to 54 months
Phase 2: Antitumor Activity Assessed by Overall Response Rate (ORR) Based on 2014 Lugano Classification Using Computerized Tomography (CT) Imaging as the Primary Modality
Time frame: Up to 54 months
Phase 1: Number of Participants With TEAEs, SAEs and DLTs in the Oral Decitabine/Cedazuridine Arm
Time frame: Up to 54 months
Ph 1 & 2: AUC: Area Under the Plasma Concentration-Time Curve
Time frame: Up to 50 months
Ph 1 & 2: Cmax: Maximum Observed Plasma Concentration
Time frame: Up to 50 months
Ph 1 & 2: Cmin: Minimum Observed Plasma Concentration at Steady State
Time frame: Up to 50 months
Ph 1 & 2: Tmax: Time to Maximum Observed Plasma Concentration
Time frame: Up to 50 months
Ph 1 & 2: t½: Apparent Elimination Half-Life
Time frame: Up to 50 months
Phase 2: Duration of response (DOR) Based on the Lugano Classification Using CT Imaging as the Primary Modality
Time frame: Up to 54 months
Phase 2: Percentage of Participants With Complete Response (CR) Based on the Lugano Classification Using CT Imaging as the Primary Modality
Time frame: Up to 54 months
Phase 2: Percentage of Participants With Partial Response (PR) Based on the Lugano Classification Using CT Imaging as the Primary Modality
Time frame: Up to 54 months
Phase 2: Progression-Free Survival (PFS) Based on the Lugano Classification Using CT Imaging as the Primary Modality
Time frame: Up to 54 months
Phase 2: Disease Control Rate (DCR) Assessed as Percentage of Participants With Disease Control Based on the Lugano Classification Using CT Imaging as the Primary Modality
Time frame: Up to 54 months
Phase 2: Overall Survival (OS) Based on the Lugano Classification Using CT Imaging as the Primary Modality
Time frame: Up to 54 months
Phase 2: Percentage of Participants With DOR, CR, PR, PFS, DCR,and OS Based on the Lugano Classification Using CT Along With PET Imaging Assessments
Duration of response (DOR), complete response (CR), partial response (PR), progression-free survival (PFS), disease control rate (DCR)and overall survival (OS)
Time frame: Up to 54 months
Phase 2: Percentage of Participants With Anti-Tumor Activity Based on Assessment Using 2014 Lugano Classification With Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC)
Anti-tumor activity in terms of ORR, DOR, CR, PR, and PFS will be evaluated based on assessment using 2014 Lugano Classification with LYRIC.
Time frame: Up to 54 months
Phase 2: Percentage of Participants With Anti-Tumor Activity Based on PTCL Subtypes Anti-tumor activity in terms of ORR, DOR, DCR, CR, and PR will be evaluated based on PTCL subtypes (using both pathology and molecular markers).
Time frame: Up to 54 months
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Taiho Oncology, Inc.