Tolinapant for Lymphoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Rochester Skin Lymphoma Medical Group, PLLC, Fairport, NY
Lymphoma+3 More
Tolinapant - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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.

Eligible Conditions

  • Lymphoma
  • Peripheral T-Cell Lymphoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 15 Secondary · Reporting Duration: Up to 54 months

Up to 50 months
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
Ph 1 & 2: Tmax: Time to Maximum Observed Plasma Concentration
Ph 1 & 2: t½: Apparent Elimination Half-Life
Up to 54 months
Phase 1: Number of Participants With TEAEs, SAEs and DLTs in the Oral Decitabine/Cedazuridine Arm
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
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
Phase 2: Duration of response (DOR) Based on the Lugano Classification Using CT Imaging as the Primary Modality
Phase 2: Overall Survival (OS) Based on the Lugano Classification Using CT Imaging as the Primary Modality
Phase 2: Percentage of Participants With Anti-Tumor Activity Based on Assessment Using 2014 Lugano Classification With Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC)
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).
Phase 2: Percentage of Participants With Complete Response (CR) Based on the Lugano Classification Using CT Imaging as the Primary Modality
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
Phase 2: Percentage of Participants With Partial Response (PR) Based on the Lugano Classification Using CT Imaging as the Primary Modality
Phase 2: Progression-Free Survival (PFS) Based on the Lugano Classification Using CT Imaging as the Primary Modality

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Phase 1: Oral Decitabine/Cedazuridine
1 of 2
Phases 1 and 2: Tolinapant + Oral Decitabine/Cedazuridine
1 of 2
Experimental Treatment

132 Total Participants · 2 Treatment Groups

Primary Treatment: Tolinapant · No Placebo Group · Phase 1 & 2

Phase 1: Oral Decitabine/Cedazuridine
Drug
Experimental Group · 1 Intervention: Decitabine + Cedazuridine · Intervention Types: Drug
Phases 1 and 2: Tolinapant + Oral Decitabine/CedazuridineExperimental Group · 2 Interventions: Decitabine + Cedazuridine, Tolinapant · Intervention Types: Drug, Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 54 months
Closest Location: Rochester Skin Lymphoma Medical Group, PLLC · Fairport, NY
Photo of new york 1Photo of new york 2Photo of new york 3
2020First Recorded Clinical Trial
2 TrialsResearching Lymphoma
1 CompletedClinical Trials

Who is running the clinical trial?

Astex Pharmaceuticals, Inc.Lead Sponsor
92 Previous Clinical Trials
7,866 Total Patients Enrolled
10 Trials studying Lymphoma
722 Patients Enrolled for Lymphoma

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a nasal type NK/T-cell lymphoma.
A malignant epitheliotropic intestinal T-cell lymphoma.
A tumor that has the histologic appearance of panniculitis-like T-cell lymphoma.
The patient has peripheral T-cells with a THF phenotype.
A type of lymphoma that is not otherwise specified.
The patient has follicular peripheral T-cell lymphoma.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.