A Study of Tolinapant in Combination With Oral Decitabine/Cedazuridine and Oral Decitabine/Cedazuridine Alone in Participants With Relapsed/Refractory Peripheral T-cell Lymphoma (R/R PTCL)

  • STATUS
    Recruiting
  • End date
    Dec 1, 2026
  • participants needed
    132
  • sponsor
    Astex Pharmaceuticals, Inc.
Updated on 7 July 2022

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.

Details
Condition Relapsed/Refractory Peripheral T-cell Lymphoma
Treatment Tolinapant, Decitabine + Cedazuridine
Clinical Study IdentifierNCT05403450
SponsorAstex Pharmaceuticals, Inc.
Last Modified on7 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Participants with expected life expectancy of >12 weeks
Participants must have histologically confirmed R/R PTCL (local pathology report) as defined by 2016 World Health Organization (WHO) classification. The following subtypes are eligible for the study
Extranodal natural killer (NK)/T-cell lymphoma nasal type
Enteropathy-associated T-cell lymphoma
Monomorphic epitheliotropic intestinal T-cell lymphoma
Hepatosplenic T-cell lymphoma
Subcutaneous panniculitis-like T-cell lymphoma
Peripheral T-cell lymphoma not otherwise specified (PTCL-NOS)
Angioimmunoblastic T-cell lymphoma
Follicular peripheral T-cell lymphoma
Nodal peripheral T-cell with T-follicular helper (THF) phenotype
Anaplastic large-cell lymphoma (ALCL)
Participants must have evidence of progressive disease and must have received at least
two prior systemic therapies
Participants must have measurable disease by contrast-enhanced diagnostic CT (at least 1 nodal lesion >1.5 centimeters (cm) or extranodal lesions >1.0 cm)
Participants with CD30-positive disease must have received, be ineligible for, or intolerant to brentuximab vedotin
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Acceptable organ function as per protocol
Women of childbearing potential (according to recommendations of the Clinical Trial Facilitation Group [CTFG]) must not be pregnant or breastfeeding and must have a negative pregnancy test at screening

Exclusion Criteria

Prior treatment with tolinapant or any hypomethylating agent
Hypersensitivity to tolinapant or oral decitabine/cedazuridine, excipients of the drug product, or other components of the study treatment regimen
Poor medical risk because of systemic diseases (e.g., uncontrolled infections) in addition to the qualifying disease under study
Life-threatening illness, significant organ system dysfunction, or other condition that, in the investigator's opinion, could compromise participant safety or the integrity of the study outcomes, or interfere with the absorption or metabolism of tolinapant
A history of, or at risk for, cardiac disease, as evidenced by 1 or more of the following conditions
Abnormal left ventricular ejection fraction
Congestive cardiac failure of Grade ≥3
Unstable cardiac disease
History or presence of complete left bundle branch block, third-degree heart block, cardiac pacemaker, or clinically significant arrhythmia
History of long QTc syndrome or ventricular arrhythmias including ventricular bigeminy
Screening 12-lead electrocardiogram (ECG) with measurable QTc interval of ≥470 milliseconds (msec) (according to either Fridericia's or Bazett's correction)
Any other condition that, in the opinion of the investigator, could put the participant at increased cardiac risk
Known history of human immunodeficiency virus (HIV) infection; or seropositive results
consistent with active hepatitis B virus (HBV) or active hepatitis C virus
(HCV) infection
Grade 3 or greater neuropathy
Known significant mental illness or other conditions such as active alcohol or other substance abuse that, in the opinion of the investigator, predisposes the participant to high risk of noncompliance with the protocol treatment or assessments
Prior anticancer treatments or therapies within the indicated time window before first dose of study treatment (tolinapant), as follows
Cytotoxic chemotherapy or radiotherapy within 4 weeks prior
Monoclonal antibodies within 4 weeks prior
At least 12 weeks must have elapsed since chimeric antigen receptor T-cell (CAR-T) infusion
Small molecules or biologics (investigational or approved) within the longer of 3 weeks or 5 half-lives before study treatment
Monoclonal antibody treatment for rheumatologic conditions within 4 weeks of study
drug initiation
Concurrent second malignancy currently requiring active therapy, except breast or prostate cancer stable on or responding to endocrine therapy or superficial bladder cancer
Any concurrent second malignancy that is metastatic
Known central nervous system (CNS) lymphoma
Participants with a history of allogeneic transplant are excluded from this study
Autotransplant within 100 days of the first dose of the study drug(s)
Systemic corticosteroids >10 mg prednisone equivalent within 7 days of the first dose of study drug(s)
Anti-T-cell directed therapy
Lymphotoxic agents (e.g., anti-CD52) in the past 12 months
Inhibitory drugs (e.g., calcineurin inhibitors) within 4 weeks of the first dose of study drug(s)
Use of a concomitant medication which is a moderate or strong CYP3A4 inhibitor/inducer
within 2 weeks of the start of the study
Use of any vaccine within 10 days of the first dose of the study drug(s)
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