Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2026-02-22 @ 5:09 PM
Study NCT ID:
NCT06479135
Status:
RECRUITING
Last Update Posted:
2025-09-25
First Post:
2024-06-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Navtemadlin add-on to Ruxolitinib in JAK Inhibitor-Naïve Patients With Myelofibrosis 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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Placebo-controlled'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-22', 'studyFirstSubmitDate': '2024-06-21', 'studyFirstSubmitQcDate': '2024-06-26', 'lastUpdatePostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare spleen volume reduction (SVR35) between Arm 1 and Arm 2', 'timeFrame': '24 weeks', 'description': 'The proportion of subjects in each arm with SVR35 by MRI/CT scan (central review) 24 weeks after start of the randomized period'}, {'measure': 'To compare total symptom score reduction (TSS50) between Arm 1 and Arm 2', 'timeFrame': '24 weeks', 'description': 'The proportion of subjects in each arm with a TSS50 by the Myelofibrosis Symptom Assessment Form (MFSAF) v4.0 24 weeks after start of the randomized period'}], 'secondaryOutcomes': [{'measure': 'To compare time to progression between Arm 1 and Arm 2', 'timeFrame': 'Up to 8 years', 'description': 'Time to progression or death from any cause in subjects randomized to each arm'}, {'measure': 'To compare overall survival (OS) between Arm 1 and Arm 2', 'timeFrame': 'Up to 8 years', 'description': 'Time to death from any cause in subjects randomized to each arm'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Navtemadlin', 'KRT-232', 'Ruxolitinib', 'POIESIS', 'TP53', 'Suboptimal response', 'Sub-optimal response'], 'conditions': ['Myelofibrosis', 'Post-PV MF', 'Post-ET Myelofibrosis', 'Primary Myelofibrosis', 'MF']}, 'descriptionModule': {'briefSummary': 'This clinical trial is evaluating whether addition of navtemadlin to ruxolitinib treatment will provide more clinical benefit than ruxolitinib alone for patients with Myelofibrosis who have a suboptimal response to ruxolitinib treatment alone.\n\nSubjects will start by receiving ruxolitinib alone in the run-in period. Those who demostrate a suboptimal response from ruxolitinib alone will then be randomized 2:1 to receive navtemadlin or navtemadlin placebo as add-on treatment to their ongoing ruxolitinib. Randomized means that subjects will be assigned to a group by chance, like a flip of a coin. The study is blinded, meaning the subjects, doctors, central endpoint assessors and sponsor will not know which add on treatment (navtemadlin or navtemadlin placebo) the subject is receiving.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria for Ruxolitinib Alone Period:\n\n* Confirmed diagnosis of PMF, post-PV MF, or post-ET MF, as assessed by the treating physician according to the World Health Organization (WHO) criteria\n* High, Intermediate-1, Intermediate-2 risk category International Prognosis System Score (IPSS)\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2\n* JAK-inhibitor treatment naive\n\nExclusion Criteria for Ruxolitinib Alone Period:\n\n* Prior Splenectomy\n* Splenic irradiation within 3 months prior to the first dose\n* Prior BCL-XL, BET, MDM2, PI3K, PIM, or XPO1 inhibitors therapy or p53-directed therapy\n* Eligible for Bone Marrow Transplant\n* Peripheral blood or bone marrow blast count ≥ 10 percent\n\nInclusion Criteria for Randomized Period:\n\n* PMF, post-PV MF, or post-ET MF that is TP53WT as assessed by central testing\n* ECOG performance status of 0 to 2\n* Treatment with a stable dose of ruxolitinib\n* Suboptimal response to run-in ruxolitinib treatment\n\nExclusion Criteria for Randomized Period:\n\n* Elevated white blood cell count that doubles (or more) during ruxolitinib treatment and exceeds 50 × 10\\^9/L\n* Peripheral blood or bone marrow blast count ≥ 10 percent'}, 'identificationModule': {'nctId': 'NCT06479135', 'acronym': 'POIESIS', 'briefTitle': 'Study of Navtemadlin add-on to Ruxolitinib in JAK Inhibitor-Naïve Patients With Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kartos Therapeutics, Inc.'}, 'officialTitle': 'A Phase 3, Randomized, Double-blind, Add-on Study Evaluating the Safety and Efficacy of Navtemadlin Plus Ruxolitinib vs Placebo Plus Ruxolitinib in JAK Inhibitor-Naïve Patients With Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib', 'orgStudyIdInfo': {'id': 'KRT-232-115'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': 'Navtemadlin administered orally once daily on Days 1-7, off treatment on Days 8-28, in 28-day treatment cycles. Ruxolitinib administered orally twice a day.', 'interventionNames': ['Drug: Navtemadlin', 'Drug: Ruxolitinib']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2', 'description': 'Navtemadlin placebo administered orally once daily on Days 1-7, off treatment on Days 8-28, in 28-day treatment cycles. Ruxolitinib administered orally twice a day.', 'interventionNames': ['Drug: Navtemadlin placebo', 'Drug: Ruxolitinib']}], 'interventions': [{'name': 'Navtemadlin', 'type': 'DRUG', 'otherNames': ['KRT-232'], 'description': 'Navtemadlin is an investigational MDM2 inhibitor', 'armGroupLabels': ['Arm 1']}, {'name': 'Navtemadlin placebo', 'type': 'DRUG', 'otherNames': ['KRT-232'], 'description': 'Navtemadlin placebo', 'armGroupLabels': ['Arm 2']}, {'name': 'Ruxolitinib', 'type': 'DRUG', 'otherNames': ['Jakafi', 'Jakavi'], 'description': 'Ruxolitinib is a janus kinase 1/2 inhibitor', 'armGroupLabels': ['Arm 1', 'Arm 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'UAB Hospital', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85234', 'city': 'Gilbert', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Banner MD Anderson Cancer Center', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Mayo Clinic - Phoenix', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'UC San Diego Moores Cancer Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'UCLA Hematology/Oncology Clinic - Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Scripps Health, Prebys Cancer Center', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '90502', 'city': 'Torrance', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '80012', 'city': 'Aurora', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Rocky Mountain Cancer Centers - 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