DNA Methyltransferase Inhibitor

Tolinapant for Peripheral T-Cell Lymphoma

Institut Gustave Roussy Site#550, Villejuif, France
Tolinapant +1 morePhase 1 & 2RecruitingResearch Sponsored by Astex Pharmaceuticals, Inc.

Study Summary

This trial is testing a new drug to see if it is safe and effective in treating leukemia.

Eligible Conditions
  • Relapsed/Refractory Peripheral T-cell Lymphoma

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
You have a documented worsening of your disease and have already tried at least two different treatments.
If you have CD30-positive disease, you must have already tried brentuximab vedotin or cannot receive it due to medical reasons.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 54 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 54 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Dose Limiting Toxicities (DLTs)
Phase 2: Antitumor Activity Assessed by Overall Response Rate (ORR) Based on 2014 Lugano Classification Using Computerized Tomography (CT) Imaging as the Primary Modality
Secondary outcome measures
Ph 1 & 2: AUC: Area Under the Plasma Concentration-Time Curve
Ph 1 & 2: Cmax: Maximum Observed Plasma Concentration
Ph 1 & 2: Cmin: Minimum Observed Plasma Concentration at Steady State
+12 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Phases 1 and 2: Tolinapant + Oral Decitabine/CedazuridineExperimental Treatment2 Interventions
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.
Group II: Phase 1: Oral Decitabine/CedazuridineExperimental Treatment1 Intervention
Decitabine/cedazuridine FDC tablet, orally, QD on days determined by the Lead-in Phase during each 28-day cycle.

Find a site

Who is running the clinical trial?

Astex Pharmaceuticals, Inc.Lead Sponsor
93 Previous Clinical Trials
7,771 Total Patients Enrolled

Media Library

Decitabine + Cedazuridine (DNA Methyltransferase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05403450 — Phase 1 & 2
Peripheral T-Cell Lymphoma Research Study Groups: Phases 1 and 2: Tolinapant + Oral Decitabine/Cedazuridine, Phase 1: Oral Decitabine/Cedazuridine
Peripheral T-Cell Lymphoma Clinical Trial 2023: Decitabine + Cedazuridine Highlights & Side Effects. Trial Name: NCT05403450 — Phase 1 & 2
Decitabine + Cedazuridine (DNA Methyltransferase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05403450 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies for people to join this research venture?

"By referencing clinicaltrials.gov, it is apparent that this research endeavour has been open to applicants since June 23rd 2022 and remains active today. The trial was last modified on the 24th of June."

Answered by AI

What is the aggregate amount of participants enrolled in this research?

"Affirmative. According to the clinicaltrials.gov site, this research is actively attempting to enroll participants with an initial posting on June 23rd 2022 and a most recent update of June 24th 2022. Thus far, 132 patients have been accepted at one medical centre."

Answered by AI
~84 spots leftby Dec 2025