Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-28 @ 12:11 AM
Study NCT ID:
NCT06313593
Status:
RECRUITING
Last Update Posted:
2025-11-07
First Post:
2024-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety, Tolerability of INCB160058 in Participants With Myeloproliferative Neoplasms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D055728', 'term': 'Primary Myelofibrosis'}], 'ancestors': [{'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 186}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2028-10-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-06', 'studyFirstSubmitDate': '2024-03-08', 'studyFirstSubmitQcDate': '2024-03-14', 'lastUpdatePostDateStruct': {'date': '2025-11-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-10-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with Dose Limiting Toxicities (DLTs)', 'timeFrame': 'Up to 28 days', 'description': 'Dose-limiting toxicity will be defined as the occurrence of any of the toxicities as per protocol.'}, {'measure': 'Number of participants with Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'Up to 2 years and 30 days', 'description': 'Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.'}, {'measure': 'Number of participants with TEAEs leading to dose modification or discontinuation', 'timeFrame': 'Up to 2 years and 30 days', 'description': 'Number of participants with TEAEs leading to dose modification or discontinuation.'}], 'secondaryOutcomes': [{'measure': 'INCB160058 and a standard disease-directed therapy pharmacokinetic (PK) in Plasma', 'timeFrame': 'Up to Day 57', 'description': 'INCB160058 and the protocol defined standard disease-directed therapy concentration in plasma.'}, {'measure': 'For participants with MF: Response using the revised IWG-MRT and ELN response criteria for MF', 'timeFrame': 'Week 12 and 24 and then every 24 weeks up to 2 years', 'description': 'Defined as the percentage of participants with Response using the revised International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) and European LeukemiaNet (ELN) response criteria.'}, {'measure': 'For participants with MF: Percentage of participants achieving spleen volume reduction as defined in the protocol', 'timeFrame': 'Week 12 and Week 24', 'description': 'Defined as percentage of participants with a protocol defined Spleen Volume Reduction.'}, {'measure': 'For participants with PV: Response using revised IWG-MRT and ELN response criteria for PV', 'timeFrame': 'Week 12 and 24 and then every 24 weeks up to 2 years', 'description': 'Defined as the percentage of participants with Response using the revised International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) and European LeukemiaNet (ELN) response criteria.'}, {'measure': 'For participants with ET: Response using revised IWG-MRT and ELN response criteria for ET', 'timeFrame': 'Week 12 and 24 and then every 24 weeks up to 2 years', 'description': 'Defined as the percentage of participants with Response using the revised International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) and European LeukemiaNet (ELN) response criteria.'}, {'measure': 'For all participants: Percentage of participants achieving ≥ 50% reduction from baseline of total symptom score (TSS)', 'timeFrame': 'Week 24', 'description': 'Defined as the percentage of participants achieving ≥ 50% reduction from baseline of TSS.'}, {'measure': 'For all participants: Symptom improvement in TSS at Weeks 12 and 24 relative to baseline as measured by the Myeloproliferative Neoplasms Symptom Assessment Form (MPN-SAF) TSS.', 'timeFrame': 'Week 12 and Week 24', 'description': 'Defined as the proportion of participants who achieve a protocol defined reduction in Total Symptomatic Score (TSS) relative to baseline as measured by the MPN-SAF TSS.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Myeloproliferative Neoplasms', 'INCB160058', 'Myelofibrosis'], 'conditions': ['Myeloproliferative Neoplasms']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.incyteclinicaltrials.com/study/?id=INCB160058-101&SearchTerm=INCB160058-101&Latitude=&Longitude=&LocationName=&conditions=&Status=&phases=&AgeRanges=&gender=&StudyTypes=&AttachmentTypes=&MileRadius=100&PageIndex=0&PageSize=10&SortField=&SortOrder=&hasResults=', 'label': 'A Study to Evaluate the Safety, Tolerability of INCB160058 in Participants With Myeloproliferative Neoplasms'}]}, 'descriptionModule': {'briefSummary': 'This study is being conducted to assess the Safety, Tolerability, and Pharmacokinetics of INCB160058 in Participants With Myeloproliferative Neoplasms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* MF:\n\n * Intermediate-1 or higher risk PMF, post-PV MF, or post-ET MF with evidence of minimum burden of disease based on splenomegaly, and for the monotherapy cohort, participants must have been previously treated with at least 1 JAK inhibitor for ≥ 12 weeks and resistant, refractory, intolerant to, or have lost response to JAK inhibitor treatment.\n * For the MF SubOpt R cohort: Therapeutic regimen prior to enrollment as defined in the protocol and unlikely to benefit from further monotherapy in the opinion of the investigator.\n* PV: Confirmed diagnosis of PV and previously treated with at least 1 prior standard cytoreductive therapy and are resistant, refractory, intolerant to, or have lost response to treatment.\n* ET: Confirmed diagnosis of high-risk ET as defined in the protocol and previously treated with at least 1 prior standard cytoreductive therapy and are resistant, refractory, intolerant to, or have lost response to treatment.\n* Life expectancy \\> 6 months.\n* Willingness to undergo a pretreatment and regular on-study bone marrow biopsies and aspirations (as appropriate to disease).\n* Existing documentation of JAK2V617F mutation from a qualified local laboratory.\n\nExclusion Criteria:\n\n* Presence of a hematological malignancy requiring treatment, other than PMF, post-PV MF, post-ET MF, PV, or ET.\n* Prior history of major bleeding or thrombosis within the 3 months prior to study enrollment.\n* Participants with abnormal hematologic, hepatic, or renal function based on laboratory evaluation.\n* Has undergone prior allogenic or autologous stem-cell transplantation or allogenic stem-cell transplantation is planned\n* Active invasive malignancy.\n* Significant concurrent, uncontrolled medical condition.\n* Acute or chronic HBV, active HCV or known HIV.\n* Any prior MPN-directed therapy within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment.\n* Participants undergoing treatment with G-CSF or GM-CSF, romiplostim, or eltrombopag at any time within 4 weeks before the first dose of study treatment.\n\nOther protocol-defined Inclusion/Exclusion Criteria may apply.'}, 'identificationModule': {'nctId': 'NCT06313593', 'briefTitle': 'A Study to Evaluate the Safety, Tolerability of INCB160058 in Participants With Myeloproliferative Neoplasms', 'organization': {'class': 'INDUSTRY', 'fullName': 'Incyte Corporation'}, 'officialTitle': 'A Phase 1, Open-Label, Multicenter Study of INCB160058 in Participants With Myeloproliferative Neoplasms', 'orgStudyIdInfo': {'id': 'INCB160058-101'}, 'secondaryIdInfos': [{'id': '2024-520353-21-00', 'type': 'REGISTRY', 'domain': 'EU CT Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1 Dose Escalation - with MF, PV or ET', 'description': 'INCB160058 will be administered at a protocol defined starting regimen to identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE\\[s\\]). Participants with myelofibrosis (MF), polycythemia vera (PV) or essential thrombocythemia (ET) will enroll in this group.', 'interventionNames': ['Drug: INCB160058']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1 Dose Escalation - with MF SubOpt R', 'description': 'INCB160058 will be administered at a protocol defined starting regimen and will allow for the evaluation of INCB160058 in combination with a standard disease-directed therapy to identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE\\[s\\]). Participants with myelofibrosis (MF), suboptimal response to a standard disease-directed therapy (SubOpt R) will enroll in this group.', 'interventionNames': ['Drug: INCB160058', 'Drug: Standard disease-directed therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2 Dose Expansion - with MF, PV or ET', 'description': 'INCB160058 will be administered at the RDE(s) identified during Part 1. Participants with MF, PV or ET will enroll in this group.', 'interventionNames': ['Drug: INCB160058']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2 Dose Expansion - with MF SubOpt R', 'description': 'INCB160058 will be administered as an add-on therapy in combination with a standard disease-directed therapy at the RDE(s) identified during Part 1. Participants with myelofibrosis (MF), suboptimal response to a standard disease-directed therapy (SubOpt R) will enroll in this group.', 'interventionNames': ['Drug: INCB160058', 'Drug: Standard disease-directed therapy']}], 'interventions': [{'name': 'INCB160058', 'type': 'DRUG', 'description': 'Oral; Tablet', 'armGroupLabels': ['Part 1 Dose Escalation - with MF SubOpt R', 'Part 1 Dose Escalation - with MF, PV or ET', 'Part 2 Dose Expansion - with MF SubOpt R', 'Part 2 Dose Expansion - with MF, PV or ET']}, {'name': 'Standard disease-directed therapy', 'type': 'DRUG', 'description': 'A standard disease-directed therapy will be administered according to Prescribing Information/SmPC.', 'armGroupLabels': ['Part 1 Dose Escalation - with MF SubOpt R', 'Part 2 Dose Expansion - with MF SubOpt R']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35249', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'The University of Alabama At Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Moffitt Cancer Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '66205', 'city': 'Fairway', 'state': 'Kansas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'The University of Kansas Cancer Center Kucc University of Kansas Clinical Research Center', 'geoPoint': {'lat': 39.02223, 'lon': -94.6319}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109-5008', 'city': 'Ann Arbor', 'state': 'Michigan', 'status': 'NOT_YET_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': '10065', 'city': 'New York', 'state': 'New York', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Cornell Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Sloan Kettering Institute For Cancer Research', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Pennsylvania Health System', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Vanderbilt-Ingram Cancer Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Md Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'facility': 'Princess Margaret Cancer Center', 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