Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 4:26 AM
Study NCT ID:
NCT04485260
Status:
UNKNOWN
Last Update Posted:
2022-05-09
First Post:
2020-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 Combined With Ruxolitinib in Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera MF (Post-PV-MF), Or Post-Essential Thrombocythemia MF (Post ET-MF) Who Have a Suboptimal Response to Ruxolitinib
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'}, {'id': 'C540383', 'term': 'ruxolitinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2024-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-05', 'studyFirstSubmitDate': '2020-07-21', 'studyFirstSubmitQcDate': '2020-07-21', 'lastUpdatePostDateStruct': {'date': '2022-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'For Phase 1: To determine the KRT-232 RP2D in combination with ruxolitinib', 'timeFrame': '15 months', 'description': 'Dose limiting toxicities will be used to establish the MTD of KRT-232 in combination with ruxolitinib. Subsequently, RP2D will be based on safety and efficacy data of the combination.'}, {'measure': 'For Phase 2:To determine the spleen volume reduction (SVR) at Week 24', 'timeFrame': '6 months after last patient enrolled', 'description': 'The proportion of subjects achieving SVR of ≥ 35% at Week 24 by MRI/CT scan'}], 'secondaryOutcomes': [{'measure': 'To determine spleen response', 'timeFrame': '43 months', 'description': 'The proportion of subjects achieving ≥35% SVR at any time point from Baseline while on study, as assessed by MRI (or by CT scan for applicable subjects)'}, {'measure': 'To determine the change in Total Symptom Score (TSS) based Myelofibrosis Symptom Assessment Form version 4.0 (MFSAF v4.0)', 'timeFrame': '43 months', 'description': 'The percentage change in TSS as measured by the MFSAF v4.0 at any time point from Baseline while on study'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['navtemadlin'], 'conditions': ['Myelofibrosis']}, 'descriptionModule': {'briefSummary': 'This is a phase 1b/2 study of KRT-232 combined with ruxolitinib in subjects with MF who have a suboptimal response after at least 18 weeks of treatment with ruxolitinib. The primary objective of the study is to determine a recommended phase 2 dose (RP2D) of KRT 232 in combination with ruxolitinib.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of PMF, post-PV MF, or post-ET MF, as assessed by treating physician according to the World Health Organization (WHO)\n* Treatment with ruxolitinib for ≥18 weeks prior to study entry, and on a stable dose of ruxolitinib in the 8 weeks prior to study entry\n* Spleen ≥5 cm palpable below the LLCM or ≥450 cm3 by MRI or CT\n* Patients must have at least 2 symptoms with a score of at least 1 on the MFSAF v4.0\n* ECOG performance status of 0 to 2\n\nExclusion Criteria:\n\n* Patients who are positive for TP53 mutations\n* Documented disease progression or clinical deterioration any time while on ruxolitinib treatment\n* Patients who have had a documented spleen response to ruxolitinib.\n* Prior splenectomy\n* Prior MDM2 inhibitor therapy or p53-directed therapy'}, 'identificationModule': {'nctId': 'NCT04485260', 'briefTitle': 'An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 Combined With Ruxolitinib in Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera MF (Post-PV-MF), Or Post-Essential Thrombocythemia MF (Post ET-MF) Who Have a Suboptimal Response to Ruxolitinib', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kartos Therapeutics, Inc.'}, 'officialTitle': 'An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 Combined With Ruxolitinib in Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera MF (Post-PV-MF), Or Post-Essential Thrombocythemia MF (Post ET-MF) Who Have a Suboptimal Response to Ruxolitinib', 'orgStudyIdInfo': {'id': 'KRT-232-109'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A, Arm 1, Cohort 1', 'description': 'KRT-232 by mouth once daily for Days 1-7, off treatment for Days 8-28 (28 day cycle)', 'interventionNames': ['Drug: KRT-232', 'Drug: Ruxolitinib']}], 'interventions': [{'name': 'KRT-232', 'type': 'DRUG', 'description': 'administered by mouth', 'armGroupLabels': ['Part A, Arm 1, Cohort 1']}, {'name': 'Ruxolitinib', 'type': 'DRUG', 'otherNames': ['Jakafi', 'Jakavi'], 'description': 'administered by mouth', 'armGroupLabels': ['Part A, Arm 1, Cohort 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'City of Hope', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'John Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '19111', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Fox Chase Cancer Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Fred Hutchinson Cancer Research Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'city': 'Adelaide', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Royal Adelaide Hospital', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'city': 'Pleven', 'status': 'RECRUITING', 'country': 'Bulgaria', 'facility': 'Dr. Georgi Stranski', 'geoPoint': {'lat': 43.41791, 'lon': 24.61666}}, {'zip': '1431', 'city': 'Sofia', 'status': 'RECRUITING', 'country': 'Bulgaria', 'facility': 'Saint Ivan Rilski Hospital', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1431', 'city': 'Sofia', 'status': 'RECRUITING', 'country': 'Bulgaria', 'facility': 'University Mutiprofile Hospital Alexandrovska', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '14033', 'city': 'Caen', 'state': 'Cedex 9', 'status': 'RECRUITING', 'country': 'France', 'facility': 'CHU de Caen', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '49933', 'city': 'Angers', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Chu Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '72000', 'city': 'Le Mans', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Centre Hospitalier du Mans', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}, {'zip': '13009', 'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Institut Paoli-Calmettes', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '34295', 'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'facility': 'CHU Saint Eloi', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Hopital Saint Louis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Tours', 'status': 'RECRUITING', 'country': 'France', 'facility': 'CHU Tours - Hôpital Bretonneau', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'zip': '52074', 'city': 'Aachen', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Universitätsklinikum Aachen Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'zip': '6120', 'city': 'Halle', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Department für Innere Medizin Universitätsklinik und Poliklinik für Innere Medizin IV Hämatologie/Onkologie', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}, {'city': 'Jena', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Universitaetsklinikum Jena', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'zip': '55131', 'city': 'Mainz', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz III. Med. Klinik und Poliklinik', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '73557', 'city': 'Mutlangen', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Stauferklinikum Schwäbisch Gmünd', 'geoPoint': {'lat': 48.82588, 'lon': 9.79714}}, {'zip': '7033001', 'city': 'Ẕerifin', 'status': 'RECRUITING', 'country': 'Israel', 'facility': 'Shamir Medical Center ( Assaf Harofeh)', 'geoPoint': {'lat': 31.95731, 'lon': 34.84852}}, {'zip': '340136', 'city': 'Bologna', 'status': 'RECRUITING', 'country': 'Italy', 'facility': 'Bologna University Hospital, Institute of Hematology', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '95124', 'city': 'Catania', 'status': 'RECRUITING', 'country': 'Italy', 'facility': 'Universita degli Studi di Catania', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'zip': '50134', 'city': 'Florence', 'status': 'RECRUITING', 'country': 'Italy', 'facility': 'University of Florence', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '47014', 'city': 'Meldola', 'status': 'RECRUITING', 'country': 'Italy', 'facility': 'Istituto Tumori della Romagna (IRST)', 'geoPoint': {'lat': 44.12775, 'lon': 12.0626}}, {'zip': '21100', 'city': 'Varese', 'status': 'RECRUITING', 'country': 'Italy', 'facility': 'Ospedale di Circolo e Fondazione MacchiASST Sette Laghi', 'geoPoint': {'lat': 45.82058, 'lon': 8.82511}}, {'city': 'Krakow', 'status': 'RECRUITING', 'country': 'Poland', 'facility': 'Oddział Kliniczny Hematologii Szpitala Uniwersyteckiego w Krakowie', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'city': 'Opole', 'status': 'RECRUITING', 'country': 'Poland', 'facility': 'Szpital Wojewódzki w Opolu Sp zooOddzial Kliniczny Hematologii', 'geoPoint': {'lat': 50.67119, 'lon': 17.92604}}, {'zip': '08035', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'facility': "d'Hebron University Hospital in Barcelona", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08916', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario Germans Trias i Pujol', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Las Palmas de Gran Canaria', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario de Gran Canaria Doctor Negrin', 'geoPoint': {'lat': 28.10178, 'lon': -15.41573}}, {'zip': '29010', 'city': 'Málaga', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Virgen de la Victoria', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'city': 'Salamanca', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario de Salamanca', 'geoPoint': {'lat': 40.42972, 'lon': -3.67975}}, {'zip': '50012', 'city': 'Zaragoza', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital de Dia Quiron Zaragoza', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}], 'centralContacts': [{'name': 'John Mei', 'role': 'CONTACT', 'email': 'jmei@kartosthera.com', 'phone': '650-542-0136'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kartos Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}