[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100511201":3},{"organization":4,"armGroups":7,"interventions":39,"overallOfficials":52,"centralContacts":56,"locations":66,"responsibleParty":345,"collaborators":45,"id":347,"slug":348,"hasResults":349,"nctId":350,"briefTitle":351,"officialTitle":352,"acronym":45,"eligibilityCriteria":353,"healthyVolunteers":349,"sex":354,"minAge":355,"maxAge":45,"enrollmentInfo":356,"targetDuration":45,"studyType":359,"phases":360,"briefSummary":362,"conditions":363,"keywords":365,"overallStatus":69,"whyStopped":45,"lastUpdateSubmitDate":369,"lastUpdatePostDateStruct":370,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":377,"locationsCount":378},{"fullName":5,"class":6},"Incyte Corporation","INDUSTRY",[8,14,18,23,27,31,35],{"label":9,"type":10,"description":11,"interventionNames":12},"Part 1a Dose Escalation Cohort Disease Group A - with MF","EXPERIMENTAL","INCA033989 will be administered at a protocol defined starting regimen in 28-day cycles as monotherapy to identify the maximum tolerated dose (MTD) and\u002For recommended dose for expansion (RDE\\[s\\]). Participants with myelofibrosis (MF) will enroll in this group.",[13],"Drug: INCA033989",{"label":15,"type":10,"description":16,"interventionNames":17},"Part 1a Dose Escalation Cohort Disease Group A - with ET","INCA033989 will be administered at a protocol defined starting regimen in 28-day cycles as monotherapy to identify the maximum tolerated dose (MTD) and\u002For recommended dose for expansion (RDE\\[s\\]). Participants with with essential thrombocythemia (ET) will enroll in this group.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Part 1a: Dose Escalation Cohort Disease Group B - with TGB-MF SubOpt R","INCA033989 will be administered at a protocol defined starting regimen in 28- day cycles and will allow for the evaluation of INCA033989 in combination with ruxolitinib to identify the maximum tolerated dose (MTD) and\u002For recommended dose for expansion (RDE\\[s\\]). Participants with myelofibrosis (MF) exhibiting suboptimal response (SubOpt R) will enroll in this group.",[13,22],"Drug: Ruxolitinib",{"label":24,"type":10,"description":25,"interventionNames":26},"Part 1b: Dose Expansion - with MF","INCA033989 will be administered as monotherapy at the RDE(s) identified during Part 1a. Participants with treatment group A (TGA) myelofibrosis MF will enroll in this group.",[13],{"label":28,"type":10,"description":29,"interventionNames":30},"Part 1b: Dose Expansion - with TGB-MF SubOpt R","INCA033989 will be administered as an add-on therapy in combination with ruxolitinibat at the RDE(s) identified during Part 1a. Participants with treatment Group B (TGB) MF SubOpt R will enroll in this group.",[13,22],{"label":32,"type":10,"description":33,"interventionNames":34},"Part 1b: Dose Expansion - with ET","INCA033989 will be administered as monotherapy at the RDE(s) identified during Part 1a. Participants with treatment group A (TGA) essential thrombocythemia (ET) will enroll in this group.",[13],{"label":36,"type":10,"description":37,"interventionNames":38},"Part 1c: Dose Expansion","INCA033989 will be administered at the dose level found to exhibit an overall positive benefit\u002Frisk as monotherapy or as combination therapy with Ruxolitinib. Participants with myelofibrosis (MF) will enroll in this group. The participants enrolled in the monotherapy arm will be offered the option to crossover to combination therapy with ruxolitinib if a suboptimal response to monotherapy is observed after 12 weeks.",[13,22],[40,46],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"DRUG","INCA033989","INCA033989 will be administered at protocol defined dose.",[15,9,19,32,24,28,36],null,{"type":41,"name":47,"description":48,"armGroupLabels":49,"otherNames":50},"Ruxolitinib","Rux will be administered according to Prescribing Information\u002FSmPC.",[19,28,36],[51],"Jakafi",[53],{"name":54,"affiliation":5,"role":55},"Incyte Medical Monitor","STUDY_DIRECTOR",[57,62],{"name":58,"role":59,"phone":60,"phoneExt":45,"email":61},"Incyte Corporation Call Center (US)","CONTACT","1.855.463.3463","medinfo@incyte.com",{"name":63,"role":59,"phone":64,"phoneExt":45,"email":65},"Incyte Corporation Call Center (ex-US)","+800 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Fe","Valencia","46026",{"type":76,"coordinates":312},[313,314],-0.37966,39.47391,{"lat":314,"lon":313},{"facility":317,"status":69,"city":318,"state":45,"zip":319,"country":320,"countryCode":321,"cosmosGeoPoint":322,"geoPoint":326,"contacts":45},"Guys and St Thomas Nhs Foundation Trust","London","SE1 9RT","United Kingdom","UK",{"type":76,"coordinates":323},[324,325],-0.12574,51.50853,{"lat":325,"lon":324},{"facility":328,"status":69,"city":329,"state":45,"zip":330,"country":320,"countryCode":321,"cosmosGeoPoint":331,"geoPoint":335,"contacts":45},"The Christie Nhs Foundation Trust Uk","Manchester","M20 4BV",{"type":76,"coordinates":332},[333,334],-2.23743,53.48095,{"lat":334,"lon":333},{"facility":337,"status":69,"city":338,"state":45,"zip":339,"country":320,"countryCode":321,"cosmosGeoPoint":340,"geoPoint":344,"contacts":45},"University of Oxford","Oxford","OX3 7LE",{"type":76,"coordinates":341},[342,343],-1.25596,51.75222,{"lat":343,"lon":342},{"type":346,"investigatorFullName":45,"investigatorTitle":45,"investigatorAffiliation":45,"oldNameTitle":45,"oldOrganization":45},"SPONSOR","100511201","phase-1-a-study-to-evaluate-inca033989-administered-as-a-monotherapy-or-in-combination-with-ruxolitinib-in-participants-with-myeloproliferative-neoplasms-100511201",false,"NCT05936359","A Study to Evaluate INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms","A Phase 1, Open-Label, Multicenter Study of INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms","Inclusion Criteria:\n\n* Life expectancy \\> 6 months.\n* Willingness to undergo a pretreatment and regular on-study BM biopsies and aspirates (as appropriate to disease).\n* Existing documentation from a qualified local laboratory of CALR exon-9 mutation.\n* Participants with MF and ET as defined in the protocol.\n\nExclusion Criteria:\n\n* Presence of any hematological malignancy other than ET, PMF, or post-ET MF.\n* Active invasive malignancy over the previous 2 years.\n* Active HBV\u002FHCV, HIV.\n* History of clinically significant or uncontrolled cardiac disease.\n* Has undergone any prior allogenic or autologous stem-cell transplantation or such transplantation is planned.\n* Laboratory values outside the Protocol-defined ranges.\n* Participants undergoing treatment with G-CSF, GM-CSF, or TPO-R agonists at any time within 4 weeks before the first dose of study treatment.\n* Prior history of major bleeding, or thrombosis within the last 3 months prior to study enrollment.\n* Any prior chemotherapy, immunomodulatory drug therapy, immunosuppressive therapy, biological therapy, endocrine therapy, targeted therapy, antibody, or hypomethylating agent used to treat the participant's disease within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment.\n* For TGBs only: Undergoing treatment with a potent\u002Fstrong inhibitor or inducer of CYP 3A4\u002F5 within 14 days or 5 half-lives (whichever is longer) before the first dose of study treatment, or expected to receive such treatment during the study.\n\nOther protocol-defined Inclusion\u002FExclusion Criteria may apply.","ALL","18 Years",{"count":357,"type":358},225,"ESTIMATED","INTERVENTIONAL",[361],"PHASE1","This study is being conducted to evaluate the safety, tolerability, and dose-limiting toxicity (DLT) and determine the maximum tolerated dose (MTD) and\u002For recommended dose(s) for expansion (RDE) of INCA033989 administered as a monotherapy or in combination with ruxolitinib in participants with myeloproliferative neoplasms.",[364],"Myeloproliferative Neoplasms",[364,47,366,367,368],"Myelofibrosis","Essential thrombocythemia","CALR mutation","2026-03-20",{"date":371,"type":372},"2026-03-24","ACTUAL",{"date":374,"type":372},"2023-09-25",{"date":376,"type":358},"2028-02-29",{"name":5,"class":6},29]