[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100540188":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":38,"centralContacts":42,"locations":52,"responsibleParty":345,"collaborators":33,"id":347,"slug":348,"hasResults":349,"nctId":350,"briefTitle":351,"officialTitle":352,"acronym":33,"eligibilityCriteria":353,"healthyVolunteers":349,"sex":354,"minAge":355,"maxAge":33,"enrollmentInfo":356,"targetDuration":33,"studyType":359,"phases":360,"briefSummary":362,"conditions":363,"keywords":365,"overallStatus":55,"whyStopped":33,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":368,"startDateStruct":371,"completionDateStruct":373,"leadSponsor":375,"locationsCount":376},{"fullName":5,"class":6},"Incyte Corporation","INDUSTRY",[8,14,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Part 1 Dose Escalation - with MF, PV or ET","EXPERIMENTAL","INCB160058 will be administered at a protocol defined starting regimen to identify the maximum tolerated dose (MTD) and\u002For recommended dose for expansion (RDE\\[s\\]). Participants with myelofibrosis (MF), polycythemia vera (PV) or essential thrombocythemia (ET) will enroll in this group.",[13],"Drug: INCB160058",{"label":15,"type":10,"description":16,"interventionNames":17},"Part 1 Dose Escalation - with MF SubOpt R","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\u002For 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.",[13,18],"Drug: Standard disease-directed therapy",{"label":20,"type":10,"description":21,"interventionNames":22},"Part 2 Dose Expansion - with MF, PV or ET","INCB160058 will be administered at the RDE(s) identified during Part 1. Participants with MF, PV or ET will enroll in this group.",[13],{"label":24,"type":10,"description":25,"interventionNames":26},"Part 2 Dose Expansion - with MF SubOpt R","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.",[13,18],[28,34],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","INCB160058","Oral; Tablet",[15,9,24,20],null,{"type":29,"name":35,"description":36,"armGroupLabels":37,"otherNames":33},"Standard disease-directed therapy","A standard disease-directed therapy will be administered according to Prescribing Information\u002FSmPC.",[15,24],[39],{"name":40,"affiliation":5,"role":41},"Incyte Medical","STUDY_DIRECTOR",[43,48],{"name":44,"role":45,"phone":46,"phoneExt":33,"email":47},"Incyte Corporation Call Center (US)","CONTACT","1.855.463.3463","medinfo@incyte.com",{"name":49,"role":45,"phone":50,"phoneExt":33,"email":51},"Incyte Corporation Call Center (ex-US)","+800 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Universitaetsspital Bern","Bern","03010","Switzerland","CH",{"type":62,"coordinates":312},[313,314],7.44744,46.94809,{"lat":314,"lon":313},{"facility":317,"status":55,"city":318,"state":33,"zip":319,"country":309,"countryCode":310,"cosmosGeoPoint":320,"geoPoint":324,"contacts":33},"Universitatsspital Zurich","Zurich","08091",{"type":62,"coordinates":321},[322,323],8.55,47.36667,{"lat":323,"lon":322},{"facility":326,"status":239,"city":327,"state":33,"zip":328,"country":329,"countryCode":330,"cosmosGeoPoint":331,"geoPoint":335,"contacts":33},"Guys and St Thomas Nhs Foundation Trust","London","SE1 9RT","United Kingdom","UK",{"type":62,"coordinates":332},[333,334],-0.12574,51.50853,{"lat":334,"lon":333},{"facility":337,"status":239,"city":338,"state":33,"zip":339,"country":329,"countryCode":330,"cosmosGeoPoint":340,"geoPoint":344,"contacts":33},"Genesiscare Oxford","Oxford","OX4 6LB",{"type":62,"coordinates":341},[342,343],-1.25596,51.75222,{"lat":343,"lon":342},{"type":346,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100540188","phase-1-a-study-to-evaluate-the-safety-tolerability-of-incb160058-in-participants-with-myeloproliferative-neoplasms-100540188",false,"NCT06313593","A Study to Evaluate the Safety, Tolerability of INCB160058 in Participants With Myeloproliferative Neoplasms","A Phase 1, Open-Label, Multicenter Study of INCB160058 in Participants With Myeloproliferative Neoplasms","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\u002FExclusion Criteria may apply.","ALL","18 Years",{"count":357,"type":358},186,"ESTIMATED","INTERVENTIONAL",[361],"PHASE1","This study is being conducted to assess the Safety, Tolerability, and Pharmacokinetics of INCB160058 in Participants With Myeloproliferative Neoplasms.",[364],"Myeloproliferative Neoplasms",[364,30,366],"Myelofibrosis","2026-04-30",{"date":369,"type":370},"2026-05-04","ACTUAL",{"date":372,"type":370},"2024-08-08",{"date":374,"type":358},"2028-10-09",{"name":5,"class":6},30]