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.Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must have evidence of progressive disease and must have received at least two prior systemic therapies
Participants with CD30-positive disease must have received, be ineligible for, or intolerant to brentuximab vedotin
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upup to 54 months
Awards & highlights
No Placebo-Only Group
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 belowSelect...
You have a documented worsening of your disease and have already tried at least two different treatments.
Select...
If you have CD30-positive disease, you must have already tried brentuximab vedotin or cannot receive it due to medical reasons.
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 moreAwards & 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
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