Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2026-02-24 @ 11:01 AM
Study NCT ID:
NCT05403450
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-03
First Post:
2022-05-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016411', 'term': 'Lymphoma, T-Cell, Peripheral'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}], 'ancestors': [{'id': 'D016399', 'term': 'Lymphoma, T-Cell'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000710345', 'term': 'ASTX-660'}, {'id': 'C000723076', 'term': 'decitabine and cedazuridine drug combination'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-06-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-30', 'studyFirstSubmitDate': '2022-05-23', 'studyFirstSubmitQcDate': '2022-05-31', 'lastUpdatePostDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Dose Limiting Toxicities (DLTs)', 'timeFrame': 'Up to 54 months', 'description': 'This will be evaluated by looking at the number of participants with treatment-related adverse events, serious adverse events (SAEs), and dose-limiting toxicities (DLTs), which are medical problems severe enough to stop study doctors from increasing a treatment dose.'}, {'measure': 'Phase 2: Antitumor Activity Assessed by Overall Response Rate (ORR) Based on 2014 Lugano Classification Using Computerized Tomography (CT) Imaging as the Primary Modality', 'timeFrame': 'Up to 54 months'}], 'secondaryOutcomes': [{'measure': 'Phase 1: Number of Participants With TEAEs, SAEs and DLTs in the Oral Decitabine/Cedazuridine Arm', 'timeFrame': 'Up to 54 months'}, {'measure': 'Ph 1 & 2: AUC: Area Under the Plasma Concentration-Time Curve', 'timeFrame': 'Up to 50 months'}, {'measure': 'Ph 1 & 2: Cmax: Maximum Observed Plasma Concentration', 'timeFrame': 'Up to 50 months'}, {'measure': 'Ph 1 & 2: Cmin: Minimum Observed Plasma Concentration at Steady State', 'timeFrame': 'Up to 50 months'}, {'measure': 'Ph 1 & 2: Tmax: Time to Maximum Observed Plasma Concentration', 'timeFrame': 'Up to 50 months'}, {'measure': 'Ph 1 & 2: t½: Apparent Elimination Half-Life', 'timeFrame': 'Up to 50 months'}, {'measure': 'Phase 2: Duration of response (DOR) Based on the Lugano Classification Using CT Imaging as the Primary Modality', 'timeFrame': 'Up to 54 months'}, {'measure': 'Phase 2: Percentage of Participants With Complete Response (CR) Based on the Lugano Classification Using CT Imaging as the Primary Modality', 'timeFrame': 'Up to 54 months'}, {'measure': 'Phase 2: Percentage of Participants With Partial Response (PR) Based on the Lugano Classification Using CT Imaging as the Primary Modality', 'timeFrame': 'Up to 54 months'}, {'measure': 'Phase 2: Progression-Free Survival (PFS) Based on the Lugano Classification Using CT Imaging as the Primary Modality', 'timeFrame': 'Up to 54 months'}, {'measure': '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', 'timeFrame': 'Up to 54 months'}, {'measure': 'Phase 2: Overall Survival (OS) Based on the Lugano Classification Using CT Imaging as the Primary Modality', 'timeFrame': 'Up to 54 months'}, {'measure': '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', 'timeFrame': 'Up to 54 months', 'description': 'Duration of response (DOR), complete response (CR), partial response (PR), progression-free survival (PFS), disease control rate (DCR)and overall survival (OS)'}, {'measure': 'Phase 2: Percentage of Participants With Anti-Tumor Activity Based on Assessment Using 2014 Lugano Classification With Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC)', 'timeFrame': 'Up to 54 months', 'description': 'Anti-tumor activity in terms of ORR, DOR, CR, PR, and PFS will be evaluated based on assessment using 2014 Lugano Classification with LYRIC.'}, {'measure': '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).', 'timeFrame': 'Up to 54 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Non-Hodgkin Lymphoma'], 'conditions': ['Relapsed/Refractory Peripheral T-cell Lymphoma']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Participants with expected life expectancy of \\>12 weeks.\n2. 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:\n\n 1. Extranodal natural killer (NK)/T-cell lymphoma nasal type.\n 2. Enteropathy-associated T-cell lymphoma.\n 3. Monomorphic epitheliotropic intestinal T-cell lymphoma.\n 4. Hepatosplenic T-cell lymphoma.\n 5. Subcutaneous panniculitis-like T-cell lymphoma.\n 6. Peripheral T-cell lymphoma not otherwise specified (PTCL-NOS).\n 7. Angioimmunoblastic T-cell lymphoma.\n 8. Follicular peripheral T-cell lymphoma.\n 9. Nodal peripheral T-cell with T-follicular helper (THF) phenotype.\n 10. Anaplastic large-cell lymphoma (ALCL).\n3. Participants must have evidence of progressive disease and must have received at least two prior systemic therapies.\n4. 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).\n5. Participants with CD30-positive disease must have received, be ineligible for, or intolerant to brentuximab vedotin.\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.\n7. Acceptable organ function as per protocol.\n8. 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.\n\nExclusion Criteria:\n\n1. Prior treatment with tolinapant or any hypomethylating agent.\n2. Hypersensitivity to tolinapant or oral decitabine/cedazuridine, excipients of the drug product, or other components of the study treatment regimen.\n3. Poor medical risk because of systemic diseases (e.g., uncontrolled infections) in addition to the qualifying disease under study.\n4. 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.\n5. A history of, or at risk for, cardiac disease, as evidenced by 1 or more of the following conditions:\n\n 1. Abnormal left ventricular ejection fraction.\n 2. Congestive cardiac failure of Grade ≥3.\n 3. Unstable cardiac disease.\n 4. History or presence of complete left bundle branch block, third-degree heart block, cardiac pacemaker, or clinically significant arrhythmia.\n 5. History of long QTc syndrome or ventricular arrhythmias including ventricular bigeminy.\n 6. Screening 12-lead electrocardiogram (ECG) with measurable QTc interval of ≥470 milliseconds (msec) (according to either Fridericia's or Bazett's correction).\n 7. Any other condition that, in the opinion of the investigator, could put the participant at increased cardiac risk.\n6. 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.\n7. Grade 3 or greater neuropathy.\n8. 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.\n9. Prior anticancer treatments or therapies within the indicated time window before first dose of study treatment (tolinapant), as follows:\n\n 1. Cytotoxic chemotherapy or radiotherapy within 4 weeks prior.\n 2. Monoclonal antibodies within 4 weeks prior.\n 3. At least 12 weeks must have elapsed since chimeric antigen receptor T-cell (CAR-T) infusion.\n 4. Small molecules or biologics (investigational or approved) within the longer of 3 weeks or 5 half-lives before study treatment.\n10. Monoclonal antibody treatment for rheumatologic conditions within 4 weeks of study drug initiation.\n11. Concurrent second malignancy currently requiring active therapy, except breast or prostate cancer stable on or responding to endocrine therapy or superficial bladder cancer.\n12. Any concurrent second malignancy that is metastatic.\n13. Known central nervous system (CNS) lymphoma.\n14. Participants with a history of allogeneic transplant are excluded from this study.\n15. Autotransplant within 100 days of the first dose of the study drug(s).\n16. Systemic corticosteroids \\>10 mg prednisone equivalent within 7 days of the first dose of study drug(s).\n17. Anti-T-cell directed therapy:\n\n 1. Lymphotoxic agents (e.g., anti-CD52) in the past 12 months.\n 2. Inhibitory drugs (e.g., calcineurin inhibitors) within 4 weeks of the first dose of study drug(s).\n18. Use of a concomitant medication which is a moderate or strong CYP3A4 inhibitor/inducer within 2 weeks of the start of the study.\n19. Use of any vaccine within 10 days of the first dose of the study drug(s)."}, 'identificationModule': {'nctId': 'NCT05403450', 'briefTitle': '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)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Taiho Oncology, Inc.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'ASTX660-03'}, 'secondaryIdInfos': [{'id': '2021-005338-40', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phases 1 and 2: Tolinapant + Oral Decitabine/Cedazuridine', 'description': '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.\n\nBased 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.', 'interventionNames': ['Drug: Tolinapant', 'Drug: Decitabine + Cedazuridine']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1: Oral Decitabine/Cedazuridine', 'description': 'Decitabine/cedazuridine FDC tablet, orally, QD on days determined by the Lead-in Phase during each 28-day cycle.', 'interventionNames': ['Drug: Decitabine + Cedazuridine']}], 'interventions': [{'name': 'Tolinapant', 'type': 'DRUG', 'otherNames': ['ASTX660'], 'description': 'Capsule for oral administration', 'armGroupLabels': ['Phases 1 and 2: Tolinapant + Oral Decitabine/Cedazuridine']}, {'name': 'Decitabine + Cedazuridine', 'type': 'DRUG', 'otherNames': ['ASTX727'], 'description': 'Tablet for oral administration', 'armGroupLabels': ['Phase 1: Oral Decitabine/Cedazuridine', 'Phases 1 and 2: Tolinapant + Oral Decitabine/Cedazuridine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope Site #151', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Califonia, Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Anschutz Medical Campus Site #118', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale Cancer Center Site #109', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Moffitt Cancer Center Site #157', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Winship Cancer Institute of Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Rogel Cancer Center', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Barbara Ann Karmanos Cancer Institute Site#159', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '14450', 'city': 'Fairport', 'state': 'New York', 'country': 'United States', 'facility': 'Rochester Skin Lymphoma Medical Group, PLLC Site #147', 'geoPoint': {'lat': 43.09867, 'lon': -77.44194}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone Laura and Isaac Perlmutter Cancer Center Site #153', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania Site# 160', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas MD Anderson Cancer Center Site #101', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia Comprehensive Cancer Center', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Fred Hutchinson Cancer Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '2139', 'city': 'Concord', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Concord Hospital', 'geoPoint': {'lat': -33.84722, 'lon': 151.10381}}, {'zip': '3168', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Monash Medical Center', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '6009', 'city': 'Nedlands', 'country': 'Australia', 'facility': 'Linear Clinical Research Site #834', 'geoPoint': {'lat': -31.98184, 'lon': 115.8073}}, {'zip': '37000', 'city': 'Tours', 'state': 'Indre-et-Loire', 'country': 'France', 'facility': 'Hôpital Bretonneau', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'zip': 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Kopernika w Łodzi', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '41013', 'city': 'Seville', 'state': 'Andalusia', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen del Rocío', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '8025', 'city': 'Barcelona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Hospital de la Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '8908', 'city': 'Barcelona', 'state': 'Catalonia', 'country': 'Spain', 'facility': "Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08003', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital del Mar Site #704', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Fundación Jiménez Díaz Site #703', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28041', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario 12 de Octubre Site#710', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '39008', 'city': 'Santander', 'country': 'Spain', 'facility': 'Hospital Universitario Marqués de Valdecilla Site#711', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}, {'zip': 'SE1 9Rt', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': "Guy's and Saint Thomas' NHS Foundation Trust", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'W1T 7HA', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': 'University College London Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M20 4BX', 'city': 'Manchester', 'state': 'England', 'country': 'United Kingdom', 'facility': 'The Christie NHS Foundation Trust', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taiho Oncology, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}