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DNA Methyltransferase Inhibitor

Tolinapant + Decitabine/Cedazuridine for Peripheral T-Cell Lymphoma

Phase 1 & 2
Recruiting
Research Sponsored by Astex Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Participants must have histologically confirmed R/R PTCL as defined by 2016 WHO classification with specific eligible subtypes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 54 months
Awards & highlights

Study Summary

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

Who is the study for?
This trial is for people with a specific type of cancer called Peripheral T-cell Lymphoma (PTCL) that has come back or didn't respond to treatment. They should have tried at least two treatments before, be expected to live more than 12 weeks, and not be pregnant or breastfeeding. They can't join if they've had certain heart problems, uncontrolled infections, significant mental illness or substance abuse issues, other active cancers needing treatment (except some breast/prostate/bladder cancers), recent other cancer treatments like chemotherapy or CAR-T therapy within specified time frames, known HIV/HBV/HCV infection, CNS lymphoma history, allogeneic transplant history or autotransplant within the last 100 days.Check my eligibility
What is being tested?
The study is testing how safe and effective a drug named Tolinapant is when given with an oral combination of Decitabine/Cedazuridine in patients with PTCL. The first phase will find the best dose to use while checking safety; the second phase will see how well it works by measuring response rates.See study design
What are the potential side effects?
While side effects are being studied as part of this trial's purpose and detailed information may not yet be available until completion of the study phases, potential side effects could include reactions related to immune system activation such as inflammation in various organs due to Tolinapant and blood cell count changes from Decitabine/Cedazuridine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself and am up and about more than half of my waking hours.
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My cancer is a type of T-cell lymphoma confirmed by tests.
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I am not pregnant or breastfeeding and my pregnancy test was negative.
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My cancer has worsened despite two previous treatments.
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I have CD30-positive disease and cannot take or have already tried brentuximab vedotin.

Timeline

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

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 Location

Who is running the clinical trial?

Astex Pharmaceuticals, Inc.Lead Sponsor
95 Previous Clinical Trials
7,829 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
~64 spots leftby Dec 2025