Ignite Creation Date:
2025-12-24 @ 7:47 PM
Ignite Modification Date:
2025-12-29 @ 5:50 PM
Study NCT ID:
NCT04878003
Status:
UNKNOWN
Last Update Posted:
2022-05-09
First Post:
2021-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of KRT-232 or TL-895 in Janus Associated Kinase Inhibitor Treatment-Naïve Myelofibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055728', 'term': 'Primary Myelofibrosis'}], 'ancestors': [{'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic 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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-05', 'studyFirstSubmitDate': '2021-05-04', 'studyFirstSubmitQcDate': '2021-05-04', 'lastUpdatePostDateStruct': {'date': '2022-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Spleen Volume Reduction (SVR)', 'timeFrame': '24 weeks', 'description': 'The proportion of subjects achieving ≥35% SVR at Week 24 by MRI/CT (central review)'}], 'secondaryOutcomes': [{'measure': 'Improvement in Total Symptom Score (TSS)', 'timeFrame': '24 weeks', 'description': 'The proportion of subjects who have at least a 50% reduction from Baseline to Week 24 in the total symptom score as measured by the MF-SAF v4.0'}, {'measure': 'Spleen Response Duration', 'timeFrame': '48 months', 'description': 'Time from initial SVR of ≥35% by MRI/CT (central review) until progression'}, {'measure': 'Rate of conversion from RBC transfusion dependent to independent', 'timeFrame': '24 weeks', 'description': 'The proportion of subjects who convert from transfusion dependent to transfusion independent at Week 24'}, {'measure': 'Overall Survival (OS)', 'timeFrame': '48 months', 'description': 'Time from first dose to death from any cause'}, {'measure': 'Progression free survival (PFS)', 'timeFrame': '48 months', 'description': 'Time from randomization to either first occurrence of disease progression or death due to any cause'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['navtemadlin'], 'conditions': ['Primary Myelofibrosis (PMF)', 'Post-Polycythemia Vera Myelofibrosis (Post-PV-MF)', 'Post-Essential Thrombocythemia Myelofibrosis (Post-ET-MF)']}, 'descriptionModule': {'briefSummary': 'This study evaluates either KRT-232 or TL-895 in treatment naïve patients with myelofibrosis (MF)\n\nThe study will be conducted in 2 stages. Stage 1 will evaluate safety, tolerability, and efficacy of either KRT-232 (Arm 1) or TL-895 (Arm 2) in treatment naïve patients. Stage 2 will expand enrollment in Arm 1 and/or Arm 2 if expansion criteria is met.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of PMF, post-PV MF or post-ET MF (WHO)\n* High-risk, or intermediate-1 and 2 risk, defined by Dynamic International Prognostic System (DIPSS)\n* ECOG of 0 or 1\n\nExclusion Criteria:\n\n* Subjects who are positive for p53 mutation (Arm 1)\n* Prior MDM2 inhibitor therapy or p53-directed therapy (Arm 1)\n* Prior treatment with any JAK inhibitor\n* Prior splenectomy\n* Splenic irradiation within 24 weeks prior to randomization\n* Prior allogeneic stem-cell transplantation or plans for allogeneic stem-cell transplant\n* History of major organ transplant\n* Grade 2 or higher QTc prolongation\n* Major hemorrhage or intracranial hemorrhage within 24 weeks prior to randomization'}, 'identificationModule': {'nctId': 'NCT04878003', 'briefTitle': 'Study of KRT-232 or TL-895 in Janus Associated Kinase Inhibitor Treatment-Naïve Myelofibrosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kartos Therapeutics, Inc.'}, 'officialTitle': 'An Open-Label, Multicenter, Phase 2 Study Assessing the Safety and Efficacy of KRT-232 or TL-895 in Janus Associated Kinase Inhibitor Treatment-Naïve Myelofibrosis', 'orgStudyIdInfo': {'id': 'KRT-232-114'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': 'KRT-232 administered orally as 240 mg once daily on Days 1-7, off treatment on Days 8-28, in 28-day treatment cycles', 'interventionNames': ['Drug: KRT-232']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2', 'description': 'TL-895 administered orally as 150 mg twice daily continuously in 28-day cycles', 'interventionNames': ['Drug: TL-895']}], 'interventions': [{'name': 'KRT-232', 'type': 'DRUG', 'description': 'KRT-232, administration by mouth', 'armGroupLabels': ['Arm 1']}, {'name': 'TL-895', 'type': 'DRUG', 'description': 'TL-895, administration by mouth', 'armGroupLabels': ['Arm 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90603', 'city': 'Glendale', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Innovative Clinical Research Institute', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'zip': '90603', 'city': 'Whittier', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Innovative Clinical Research Institute', 'geoPoint': {'lat': 33.97918, 'lon': -118.03284}}, {'zip': '44718', 'city': 'Canton', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Gabrail Cancer Center', 'geoPoint': {'lat': 40.79895, 'lon': -81.37845}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '246040', 'city': 'Belarus’', 'status': 'RECRUITING', 'country': 'Belarus', 'facility': 'Republican Scientific Practical Center of Radiation Medicine and Human Ecology', 'geoPoint': {'lat': 53.0282, 'lon': 27.3137}}, {'zip': '220045', 'city': 'Minsk', 'status': 'RECRUITING', 'country': 'Belarus', 'facility': 'Minsk Scientific and Practice Center of Surgery, Transplantology and Hematology', 'geoPoint': {'lat': 53.90019, 'lon': 27.56653}}, {'zip': '5800', 'city': 'Pleven', 'status': 'RECRUITING', 'country': 'Bulgaria', 'facility': 'UMHAT Georgi Stranski', 'geoPoint': {'lat': 43.41791, 'lon': 24.61666}}, {'zip': '4000', 'city': 'Plovdiv', 'status': 'RECRUITING', 'country': 'Bulgaria', 'facility': 'Medical Centre Hipokrat N', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}, {'zip': '1431', 'city': 'Sofia', 'status': 'RECRUITING', 'country': 'Bulgaria', 'facility': 'UMHAT Sv. Ivan Rilski EAD', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1606', 'city': 'Sofia', 'status': 'RECRUITING', 'country': 'Bulgaria', 'facility': 'Military Medical Academy', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1756', 'city': 'Sofia', 'status': 'RECRUITING', 'country': 'Bulgaria', 'facility': 'Specialized Hospital for Active Treatment of Hematologic Diseases', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '4600', 'city': 'Kutaisi', 'status': 'RECRUITING', 'country': 'Georgia', 'facility': 'JSC EVEX Hospitals', 'geoPoint': {'lat': 42.26791, 'lon': 42.69459}}, {'zip': '112', 'city': 'Tbilisi', 'status': 'RECRUITING', 'country': 'Georgia', 'facility': 'LTD M.Zodelava Hematology Centre', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '159', 'city': 'Tbilisi', 'status': 'RECRUITING', 'country': 'Georgia', 'facility': 'K.Eristavi National Center of Experimental and Clinical Surgery', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '20116', 'city': 'Aguascalientes', 'status': 'RECRUITING', 'country': 'Mexico', 'facility': 'Centro de Investigacion Medica Aquascalientes (CIMA)', 'geoPoint': {'lat': 21.88262, 'lon': -102.2843}}, {'zip': '31200', 'city': 'Chihuahua City', 'status': 'RECRUITING', 'country': 'Mexico', 'facility': 'Unidad de Investigacion CIMA SC', 'geoPoint': {'lat': 28.63528, 'lon': -106.08889}}, {'zip': '68020', 'city': 'Oaxaca City', 'status': 'RECRUITING', 'country': 'Mexico', 'facility': 'Centro de Investigacion Clinica de Oaxaca (CICLO)', 'geoPoint': {'lat': 17.06025, 'lon': -96.72544}}, {'zip': '91900', 'city': 'Veracruz', 'status': 'RECRUITING', 'country': 'Mexico', 'facility': 'Sociedad de Metabolismo Y Corazon - SOMECO', 'geoPoint': {'lat': 19.18095, 'lon': -96.1429}}, {'zip': '40-519', 'city': 'Katowice', 'status': 'RECRUITING', 'country': 'Poland', 'facility': 'Samodzielny Publiczny Zakład Opieki Zdrowotnej Zespół Szpitali Miejskich', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'zip': '45-061', 'city': 'Opole', 'status': 'RECRUITING', 'country': 'Poland', 'facility': 'Szpital Wojewodzki w Opolu Sp. z o.o., Oddzial Hematologii i Onkologii Hematologicznej', 'geoPoint': {'lat': 50.67119, 'lon': 17.92604}}, {'zip': '76-200', 'city': 'Słupsk', 'status': 'RECRUITING', 'country': 'Poland', 'facility': 'Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o.', 'geoPoint': {'lat': 54.46405, 'lon': 17.02872}}, {'zip': '125284', 'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'facility': 'Botkin City Clinical Hospital', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '185019', 'city': 'Petrozavodsk', 'status': 'RECRUITING', 'country': 'Russia', 'facility': 'Republican Hospital n.a. V.A. Baranov', 'geoPoint': {'lat': 61.78491, 'lon': 34.34691}}, {'zip': '197022', 'city': 'Saint Petersburg', 'status': 'RECRUITING', 'country': 'Russia', 'facility': 'Pavlov First Saint Petersburg State Medical University', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '197341', 'city': 'Saint Petersburg', 'status': 'RECRUITING', 'country': 'Russia', 'facility': 'Almazov National Medical Research Center', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '197341', 'city': 'Saint Petersburg', 'status': 'RECRUITING', 'country': 'Russia', 'facility': 'Almazov National Medical Research Centre', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '443099', 'city': 'Samara', 'status': 'RECRUITING', 'country': 'Russia', 'facility': 'Samara State Medical University', 'geoPoint': {'lat': 53.20767, 'lon': 50.13553}}, {'zip': '1519', 'city': 'Soweto', 'status': 'RECRUITING', 'country': 'South Africa', 'facility': 'Wits Baragwanath Clinical Hematology Department', 'geoPoint': {'lat': -26.26781, 'lon': 27.85849}}, {'zip': '49102', 'city': 'Dnipro', 'status': 'RECRUITING', 'country': 'Ukraine', 'facility': 'City Hematology Center of Municipal Non-Profit Enterprise City Clinical Hospital #4 of Dnipro City Council', 'geoPoint': {'lat': 48.46664, 'lon': 35.04066}}], 'centralContacts': [{'name': 'John Mei', 'role': 'CONTACT', 'email': 'jmei@kartosthera.com', 'phone': '650-542-0136'}, {'name': 'Jordan Blevins', 'role': 'CONTACT', 'email': 'jblevins@kartosthera.com', 'phone': '650-542-0136'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kartos Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}