Your session is about to expire
← Back to Search
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 belowSelect...
I can take care of myself and am up and about more than half of my waking hours.
Select...
My cancer is a type of T-cell lymphoma confirmed by tests.
Select...
I am not pregnant or breastfeeding and my pregnancy test was negative.
Select...
My cancer has worsened despite two previous treatments.
Select...
I have CD30-positive disease and cannot take or have already tried brentuximab vedotin.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 54 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 54 months
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 moreTrial 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can take care of myself and am up and about more than half of my waking hours.I have a history of heart problems or am at risk for them.My cancer is a type of T-cell lymphoma confirmed by tests.I am not pregnant or breastfeeding and my pregnancy test was negative.My cancer has worsened despite two previous treatments.I have CD30-positive disease and cannot take or have already tried brentuximab vedotin.I have been diagnosed with lymphoma in my central nervous system.My organs are functioning well.I have previously been treated with tolinapant or drugs that affect DNA methylation.I have severe nerve damage.I have a serious health condition besides cancer.I have a severe illness or major organ problem.I haven't had cancer treatment recently.I have recently received therapy targeting T-cells.I am taking medication that strongly affects liver enzyme CYP3A4.I am currently receiving treatment for another cancer.I have not received any vaccines in the last 10 days.I haven't taken more than 10 mg of steroids like prednisone in the last week.I have a history of HIV, or active hepatitis B or C.I had a transplant from a donor or myself within the last 100 days.
Research Study Groups:
This trial has the following groups:- Group 1: Phases 1 and 2: Tolinapant + Oral Decitabine/Cedazuridine
- Group 2: Phase 1: Oral Decitabine/Cedazuridine
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
Share this study with friends
Copy Link
Messenger