Tolinapant and Oral Decitabine/Cedazuridine in relapse refractory PTCL
Research type
Research Study
Full title
A Phase 1-2, Open-Label Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Activity of Tolinapant in Combination with Oral Decitabine/Cedazuridine and Oral Decitabine/Cedazuridine Alone in Subjects with Relapsed/Refractory Peripheral T-cell Lymphoma
IRAS ID
1005334
Contact name
Lillian Chu
Contact email
Sponsor organisation
Astex Pharmaceuticals, Inc.
Eudract number
2021-005338-40
Clinicaltrials.gov Identifier
Research summary
Researchers are looking for a better way to treat a cancer called “peripheral T-cell lymphoma”, also called “PTCL”, that is “relapsed” or “refractory”. One of the study treatments, tolinapant, is designed to block specific proteins in the body from working. The other study treatments, decitabine and cedazuridine, are combined cancer treatments currently used by doctors to target and destroys cancer cells.
This study will include up to about 132 men and women with relapsed or refractory PTCL. Participants will be at least 18 years old when they join this study. This study has 2 main purposes: to learn about the safety of different doses of the treatments taken together, and how they affect tumors. This will help researchers determine which doses work and are safe for study participants.
The researchers will study the following main results throughout the study: medical problems and dose-limiting toxicities in participants who take the treatments together experience (dose-limiting toxicities, also called “DLTs”, are medical problems severe enough to stop study doctors from increasing a treatment dose); combined percentage of participants whose tumors shrink by at least 50% or disappear.
The researchers will also study: medical problems and DLTs in participants who take only combined decitabine and cedazuridine experience; how the treatments act in the blood; how the tumors respond to treatment; length of time participants live after taking treatment.
Participants are planned to be in this study for approx. 4.5 years. How long they participate in the study will depend on how they respond to treatment. This study will be “open label”, which means the participants, doctors, and study staff will know what treatments participants take. Participants will take tolinapant and combined decitabine and cedazuridine, or only combined decitabine and cedazuridine. Treatment will be taken during 4-week periods called “cycles”.REC name
South Central - Oxford A Research Ethics Committee
REC reference
22/SC/0244
Date of REC Opinion
4 Oct 2022
REC opinion
Further Information Favourable Opinion