Ignite Creation Date:
2025-12-25 @ 12:26 AM
Ignite Modification Date:
2025-12-25 @ 10:32 PM
Study NCT ID:
NCT05027867
Status:
TERMINATED
Last Update Posted:
2023-08-16
First Post:
2021-08-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
KRT-232 in Subjects With Relapsed or Refractory Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000723723', 'term': 'navtemadlin; 2-((3R,5R,6S)-5-(3-chlorophenyl)-6-(4-chlorophenyl)-1-((S)-1-(isopropylsulfonyl)-3-methylbutan-2-yl)-3-methyl-2-oxopiperidin-3-yl)acetic acid'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'Unanticipated and extremely high screen failure rate. There was no evidence of safety concerns in the study.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-12-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2022-08-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-14', 'studyFirstSubmitDate': '2021-08-25', 'studyFirstSubmitQcDate': '2021-08-25', 'lastUpdatePostDateStruct': {'date': '2023-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective response rate (ORR) of each arm', 'timeFrame': '24 weeks', 'description': 'The proportion of subjects achieving partial response or better per RECIST 1.1'}], 'secondaryOutcomes': [{'measure': 'Duration of response (DOR) of each arm', 'timeFrame': '1 year', 'description': 'Time from initiation of response to disease progression or death'}, {'measure': 'Progression-free survival (PFS) of each arm', 'timeFrame': '1 year', 'description': 'Time from first dose to disease progression or death'}, {'measure': 'Overall survival (OS) of each arm', 'timeFrame': '1 year', 'description': 'Time from first dose to death'}, {'measure': 'Disease control rate (DCR) of each arm', 'timeFrame': '24 weeks', 'description': 'The proportion of subjects achieving stable disease or better per RECIST 1.1'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['navtemadlin'], 'conditions': ['Small-cell Lung Cancer', 'Small Cell Lung Carcinoma', 'Small Cell Lung Cancer Extensive Stage', 'Small Cell Lung Cancer Recurrent']}, 'descriptionModule': {'briefSummary': 'This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with relapsed or refractory small cell lung cancer.\n\nThis study will be conducted in 2 parts. Part 1 will evaluate two treatment arms, each with a different KRT-232 dose. Part 2 will continue the evaluation of the selected treatment arms from Part 1.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of SCLC documented as TP53WT\n* Disease must be measurable per RECIST Version 1.1\n* Evidence of radiographic progression during or after at least one prior platinum-containing therapy with no curative therapy available. Subjects who have received only one prior line of therapy must not be candidates for platinum-based regimens at relapse.\n* Subjects must have received a checkpoint inhibitor (PD-1 or PD-L1) unless contraindicated if checkpoint inhibitors are approved and available.\n* ECOG ≤ 2\n\nExclusion Criteria:\n\n* Symptomatic or uncontrolled central nervous system (CNS) metastases.\n* Prior treatment with MDM2 inhibitors\n* Chemotherapy, immune therapy, cytokine therapy, or any investigational therapy within 14 days prior to the first dose of study treatment\n* Grade 2 or higher QTc prolongation (\\> 480 milliseconds per NCI-CTCAE criteria, version 5.0)\n* History of major organ transplant'}, 'identificationModule': {'nctId': 'NCT05027867', 'briefTitle': 'KRT-232 in Subjects With Relapsed or Refractory Small Cell Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kartos Therapeutics, Inc.'}, 'officialTitle': 'An Open-Label, Multicenter, Phase 2 Study of the Safety and Efficacy of KRT-232 in Subjects With Relapsed or Refractory Small Cell Lung Cancer (SCLC)', 'orgStudyIdInfo': {'id': 'KRT-232-112'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': 'KRT-232 240 mg by mouth once daily for Days 1-7, off treatment for Days 8-21 (21-day cycles)', 'interventionNames': ['Drug: KRT-232']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2', 'description': 'KRT-232 180 mg by mouth once daily for Days 1-7, off treatment for Days 8-21 (21-day cycles)', 'interventionNames': ['Drug: KRT-232']}], 'interventions': [{'name': 'KRT-232', 'type': 'DRUG', 'otherNames': ['navtemadlin'], 'description': 'Administered by mouth', 'armGroupLabels': ['Arm 1', 'Arm 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33901', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Specialists - 3840 Broadway', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '33705', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Specialists - 560 Jackson St, Suite 220', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '33401', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Specialists', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '30060', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Northwest Georgia Oncology Centers', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '70809', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Hematology Oncology Clinic', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals Cleveland Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43213', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Mark H Zangmeister Center - 3100 Plaza Properties Boulevard', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '37404', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'SCRI Tennessee Oncology Chattanooga', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '37205', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'SCRI Tennessee Oncology Nashville', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '5042', 'city': 'Bedford Park', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Flinders Medical Centre', 'geoPoint': {'lat': -35.02204, 'lon': 138.56815}}, {'zip': '68000', 'city': 'Mulhouse', 'state': 'France/Haut-Rhin', 'country': 'France', 'facility': 'Centre Hospitalier de Mulhouse - Hopital Emile Muller', 'geoPoint': {'lat': 47.75205, 'lon': 7.32866}}, {'zip': '49933', 'city': 'Angers', 'state': 'Maine-et-Loire', 'country': 'France', 'facility': 'Edog - Ico - Ppds', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '69677', 'city': 'Bron', 'state': 'Rhône', 'country': 'France', 'facility': 'Hôpital Louis Pradel', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}, {'zip': '69495', 'city': 'Lyon', 'state': 'Rhône', 'country': 'France', 'facility': 'Hospices Civils de Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '69310', 'city': 'Pierre-Bénite', 'state': 'Rhône', 'country': 'France', 'facility': 'Hôpital de La Croix Rousse', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': '33000', 'city': 'Bordeaux', 'country': 'France', 'facility': 'EDOG - Institut Bergonie - PPDS', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': 'CHU de Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '13915', 'city': 'Marseille', 'country': 'France', 'facility': 'Hopital Nord AP-HM', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '73730', 'city': 'Esslingen am Neckar', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Klinik für Kardiologie, Angiologie und Pneumologie', 'geoPoint': {'lat': 48.73961, 'lon': 9.30473}}, {'zip': '34376', 'city': 'Immenhausen', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Lungenfachklinik Immenhausen', 'geoPoint': {'lat': 51.42763, 'lon': 9.48017}}, {'zip': '13125', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Evangelische Lungenklinik Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '6000', 'city': 'Kecskemét', 'state': 'Bács-Kiskun county', 'country': 'Hungary', 'facility': 'Bacs Kiskun Megyei Korhaz', 'geoPoint': {'lat': 46.90618, 'lon': 19.69128}}, {'zip': '13520', 'city': 'Seongnam-si', 'state': 'Gyeonggido', 'country': 'South Korea', 'facility': 'CHA Bundang Medical Center, CHA University', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}, {'zip': '28644', 'city': 'Cheongju-si', 'state': 'North Chungcheong', 'country': 'South Korea', 'facility': 'Chungbuk National University Hospital', 'geoPoint': {'lat': 36.63722, 'lon': 127.48972}}, {'zip': '31008', 'city': 'Pamplona', 'state': 'Navarre', 'country': 'Spain', 'facility': 'Clinica Universidad Navarra', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'zip': '28007', 'city': 'Alicante', 'country': 'Spain', 'facility': 'Hospital Universitario 12 de Octubre', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'zip': '3010', 'city': 'Alicante', 'country': 'Spain', 'facility': 'Hospital General Universitario de Alicante', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'zip': '0825', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Universitario Vall d'Hebrón - PPDS", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28027', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Clinica Universidad Navarra - Madrid', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28046', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario La Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '29011', 'city': 'Málaga', 'country': 'Spain', 'facility': 'Hospital Regional Universitario de Malaga - Hospital Civil', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '41071', 'city': 'Seville', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen Macarena', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '46026', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Universitari i Politecnic La Fe de Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kartos Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}