Ignite Creation Date:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2025-12-31 @ 6:35 PM
Study NCT ID:
NCT05980806
Status:
RECRUITING
Last Update Posted:
2025-02-05
First Post:
2023-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Selinexor Monotherapy in Subjects with JAK Inhibitor-naïve Myelofibrosis and Moderate Thrombocytopenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055728', 'term': 'Primary Myelofibrosis'}, {'id': 'D013921', 'term': 'Thrombocytopenia'}], 'ancestors': [{'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D000095542', 'term': 'Cytopenia'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C585161', 'term': 'selinexor'}, {'id': 'C540383', 'term': 'ruxolitinib'}, {'id': 'C561234', 'term': '11-(2-pyrrolidin-1-ylethoxy)-14,19-dioxa-5,7,26-triazatetracyclo(19.3.1.1(2,6).1(8,12))heptacosa-1(25),2(26),3,5,8,10,12(27),16,21,23-decaene'}, {'id': 'C546012', 'term': 'N-(cyanomethyl)-4-(2-((4-(4-morpholinyl)phenyl)amino)-4-pyrimidinyl)benzamide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 118}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2028-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-03', 'studyFirstSubmitDate': '2023-07-24', 'studyFirstSubmitQcDate': '2023-07-31', 'lastUpdatePostDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Participants with Spleen Volume Reduction 35 (SVR35) at Week 24.', 'timeFrame': 'At Week 24', 'description': 'Measured by Magnetic Resonance Imaging (MRI) or Computed Tomography (CT) Scan'}], 'secondaryOutcomes': [{'measure': 'Number of Participants with Treatment-emergent Adverse Events (TEAEs), Severity of TEAEs, Treatment Related Adverse Events (TRAEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'From start of drug administration up to 30 days after the last dose of study treatment (approximately 48 months)'}, {'measure': 'Proportion of Participants with Total Symptom Score 50 (TSS50) at Week 24.', 'timeFrame': 'At Week 24', 'description': 'Measured by the Myelofibrosis Symptom Assessment Form (MFSAF) V4.0. A higher Total Symptom Score (TSS) indicates a higher disease burden and thus a worse outcome.'}, {'measure': 'Proportion of Participants with Anemia Response at Week 24 as per the International Working Group Myeloproliferative Neoplasms Research and Treatment and European Leukemia Network (IWG-MRT and ELN) Criteria', 'timeFrame': 'At Week 24'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'From date of randomization to the date of death due to any cause or EoS (assessed at approximately 48 months)'}, {'measure': 'Overall Response Rate (ORR) as per IWG MRT and ELN Criteria', 'timeFrame': 'From Cycle 1 Day 1 (28-day cycle) up to EoS (approximately 48 months)'}, {'measure': 'Proportion of Participants with SVR35 at Any Time Point.', 'timeFrame': 'From Baseline to EoS (approximately 48 months)', 'description': 'Measured by MRI or CT Scan.'}, {'measure': 'Proportion of Participants with TSS50 at Any Time.', 'timeFrame': 'From Baseline to EoS (approximately 48 months)', 'description': 'Measured by the MFSAF V4.0. A higher Total Symptom Score (TSS) indicates a higher disease burden and thus a worse outcome.'}, {'measure': 'SVR35 Response in Pre-specified MF Participant Subgroups (Including by Gender, Age, and Geographic Region)', 'timeFrame': 'From Baseline up to EoS (approximately 48 months)'}, {'measure': 'TSS50 Response in Pre-specified MF Participant Subgroups (Including by Gender, Age, and Geographic Region)', 'timeFrame': 'From Baseline up to EoS (approximately 48 months)'}, {'measure': 'Anemia Response in Pre-specified MF Participant Subgroups (Including by Gender, Age, and Geographic Region)', 'timeFrame': 'From Baseline up to EoS (approximately 48 months)'}, {'measure': 'SVR35 Response in Participants who Receive as add-on Treatments (Ruxolitinib or Pacritinib or Momelotinib) to Selinexor and Single-agent Selinexor Only', 'timeFrame': 'At Week 24'}, {'measure': 'TSS50 Response in Participants who Receive as add-on Treatments (Ruxolitinib or Pacritinib or Momelotinib) to Selinexor and Single-agent Selinexor Only', 'timeFrame': 'At Week 24'}, {'measure': 'Anemia Response in Participants who Receive as add-on Treatments (Ruxolitinib or Pacritinib or Momelotinib) to Selinexor and Single-agent Selinexor Only', 'timeFrame': 'At Week 24'}, {'measure': 'Number of Participants with TEAEs, Severity of TEAEs, TRAEs and SAEs in Participants who Receive as add-on Treatments (Ruxolitinib or Pacritinib or Momelotinib) to Selinexor and Single-agent Selinexor Only', 'timeFrame': 'From start of drug administration up to 30 days after the last dose of study treatment (approximately 48 months)'}, {'measure': 'Area Under the Concentration-time Curve (AUC) of Selinexor', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Cycle 1 Day 15 and 2 hours post-dose on Cycle 2 Day 15 (28-day cycle)'}, {'measure': 'Maximum Plasma Concentration (Cmax) of Selinexor', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Cycle 1 Day 15 and 2 hours post-dose on Cycle 2 Day 15 (28-day cycle)'}, {'measure': 'Time at Which Cmax is Achieved (Tmax) of Selinexor', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Cycle 1 Day 15 and 2 hours post-dose on Cycle 2 Day 15 (28-day cycle)'}, {'measure': 'Duration of Receptor Occupancy or Exportin 1 (XPO1) mRNA Induction', 'timeFrame': 'From Baseline up to EoS (approximately 48 months)'}, {'measure': 'Proportion of Participants with Post-treatment Changes in Bone Marrow', 'timeFrame': 'From Baseline up to EoS (approximately 48 months)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Myelofibrosis', 'Selinexor', 'Total Symptom Score', 'Myelofibrosis Symptom Assessment Form', 'Spleen Volume Reduction', 'TSS50', 'SVR35', 'JAK2', 'KPT-330', 'Pacritinib', 'Ruxolitinib', 'Momelotinib', 'Thrombocytopenia'], 'conditions': ['Myelofibrosis', 'Moderate Thrombocytopenia']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study with corresponding optional expansion is to evaluate the efficacy of selinexor in JAKi-naïve participants with myelofibrosis (MF) and moderate thrombocytopenia based on spleen volume reduction (SVR). Additional efficacy and safety parameters will also be assessed during the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* A diagnosis of MF or post-ET or post-PV MF according to the 2016 World Health Organization (WHO) classification of MPN, confirmed by the most recent local pathology report.\n* Measurable splenomegaly during the screening period as demonstrated by spleen volume of greater than equal to (\\>=) 450 cubic square centimeter (cm\\^3) by MRI or CT scan (results from MRI or CT imaging performed within 28 days prior to screening are acceptable).\n* Participants with DIPSS risk category of intermediate-1 with symptoms, or intermediate-2, or high-risk.\n* ECOG Performance Status less than or equal to (\\<=) 2.\n* Platelet count of 50 to less than (\\<) 100 x 10\\^9/L without platelet transfusion within 7 days prior to the first dose of selinexor.\n* Absolute neutrophil count (ANC) \\>=1.0 × 10\\^9/L without need for growth factors within 7 days prior to the first dose of selinexor.\n* Adequate liver function as defined by the following: aspartate transaminase (AST) and alanine aminotransferase (ALT) \\<= 2.5 × upper limit normal (ULN) and serum total bilirubin \\<= 3×ULN.\n* Calculated creatinine clearance (CrCl) greater than (\\>) 15 milliliter per minute (mL/min) based on the Cockcroft and Gault formula.\n* Active symptoms of MF as determined by presence of at least 2 symptoms with a score \\>= 3 or total score of \\>= 10 at screening using the MFSAF V4.0.\n* Participants must provide bone marrow biopsy samples (samples obtained up to 3 months prior to C1D1 are permitted) at screening and during the study.\n* Participants currently not a candidate for stem cell transplantation.\n* Participants must be willing to complete the MFSAF V4.0 daily during the study for evaluating the symptom response (i.e., TSS50).\n\nKey Exclusion Criteria:\n\n* More than 10% blasts in peripheral blood or bone marrow (accelerated or blast phase).\n* Previous treatment with JAK inhibitors for MF.\n* Previous treatment with selinexor or other XPO1 inhibitors.\n* Female participants who are pregnant or lactating.\n* Prior splenectomy, or splenic radiation within 6 months prior to C1D1.\n* History of myocardial infarction, unstable angina, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG), cerebrovascular accident (stroke or transient ischemic attack \\[TIA\\]), ventricular arrhythmias, congestive heart failure New York Heart Association (NYHA) class \\> 2 within 6 months of C1D1.\n* Participants unable to tolerate two forms of antiemetics prior to each dose for the first two cycles.'}, 'identificationModule': {'nctId': 'NCT05980806', 'acronym': 'SENTRY-2', 'briefTitle': 'A Study of Selinexor Monotherapy in Subjects with JAK Inhibitor-naïve Myelofibrosis and Moderate Thrombocytopenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Karyopharm Therapeutics Inc'}, 'officialTitle': 'A Phase 2 Study to Evaluate the Efficacy and Safety of Selinexor Monotherapy in Subjects with JAK Inhibitor-naïve Myelofibrosis and Moderate Thrombocytopenia', 'orgStudyIdInfo': {'id': 'XPORT-MF-044'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Selinexor 60 mg (Arm 1)', 'description': 'Participants will receive selinexor 60 milligrams (mg) oral tablets once weekly (QW) (Days 1, 8, 15, and 22 of each 28-day cycle) until PD, intolerable toxicity, or until they meet the criteria for discontinuation of study treatment, death, or withdrawal of consent, whichever comes first and followed by optional add-on medication dosing may be initiated based on Spleen Volume Reduction (SVR) values.', 'interventionNames': ['Drug: Selinexor 60 mg', 'Drug: Ruxolitinib', 'Drug: Pacritinib', 'Drug: Momelotinib']}, {'type': 'EXPERIMENTAL', 'label': 'Selinexor 40 mg (Arm 2)', 'description': 'Participants will receive selinexor 40 mg oral tablets QW (Days 1, 8, 15, and 22 of each 28-day cycle) until PD, intolerable toxicity, or until they meet the criteria for discontinuation of study treatment, death, or withdrawal of consent, whichever comes first and followed by optional add-on medication dosing may be initiated based on SVR values.', 'interventionNames': ['Drug: Selinexor 40 mg', 'Drug: Ruxolitinib', 'Drug: Pacritinib', 'Drug: Momelotinib']}, {'type': 'EXPERIMENTAL', 'label': 'Selinexor 60 mg (Optional Expansion Arm)', 'description': 'Participants will receive selinexor 60 mg oral tablets QW (Days 1, 8, 15, and 22 of each 28-day cycle) until PD, intolerable toxicity, or until they meet the criteria for discontinuation of study treatment, death, or withdrawal of consent, whichever comes first. Optional add-on medication (ruxolitinib \\[5 mg or 10 mg twice daily\\], pacritinib \\[200 mg twice daily\\], or momelotinib \\[200 mg once daily\\]) may be initiated for participants whose SVR is less than (\\<) 10% at Week 12 or \\<35% at Week 24 based on the participants platelet count values (i.e., ruxolitinib if platelets greater than or equal to \\[\\>=\\] 50 x 10\\^9/L, pacritinib if platelets \\<50 x 10\\^9/L, momelotinib if platelets is \\>=50 x 10\\^9/L and hemoglobin level is \\< 10 gram per deciliter \\[g/dL\\]).', 'interventionNames': ['Drug: Selinexor 60 mg', 'Drug: Ruxolitinib', 'Drug: Pacritinib', 'Drug: Momelotinib']}, {'type': 'EXPERIMENTAL', 'label': 'Selinexor 40 mg (Optional Expansion Arm)', 'description': 'Participants will receive selinexor 40 mg oral tablets QW (Days 1, 8, 15, and 22 of each 28-day cycle) until PD, intolerable toxicity, or until they meet the criteria for discontinuation of study treatment, death, or withdrawal of consent, whichever comes first. Optional add-on medication (ruxolitinib \\[5 mg or 10 mg twice daily\\], pacritinib \\[200 mg twice daily\\], or momelotinib \\[200 mg once daily\\]) may be initiated for participants whose SVR is \\<10% at Week 12 or \\<35% at Week 24 based on the participants platelet count values (i.e., ruxolitinib if platelets \\>= 50 x 10\\^9/L, pacritinib if platelets \\<50 x 10\\^9/L, momelotinib if platelets is \\>=50 x 10\\^9/L and hemoglobin level is \\< 10 g/dL).', 'interventionNames': ['Drug: Selinexor 40 mg', 'Drug: Ruxolitinib', 'Drug: Pacritinib', 'Drug: Momelotinib']}], 'interventions': [{'name': 'Selinexor 60 mg', 'type': 'DRUG', 'otherNames': ['KPT-330'], 'description': 'Participants will receive selinexor 60 mg oral tablets QW.', 'armGroupLabels': ['Selinexor 60 mg (Arm 1)', 'Selinexor 60 mg (Optional Expansion Arm)']}, {'name': 'Selinexor 40 mg', 'type': 'DRUG', 'otherNames': ['KPT-330'], 'description': 'Participants will receive selinexor 40 mg oral tablets QW.', 'armGroupLabels': ['Selinexor 40 mg (Arm 2)', 'Selinexor 40 mg (Optional Expansion Arm)']}, {'name': 'Ruxolitinib', 'type': 'DRUG', 'otherNames': ['JAKAFI'], 'description': 'Participants will receive ruxolitinib 5 mg or 10 mg twice daily.', 'armGroupLabels': ['Selinexor 40 mg (Arm 2)', 'Selinexor 40 mg (Optional Expansion Arm)', 'Selinexor 60 mg (Arm 1)', 'Selinexor 60 mg (Optional Expansion Arm)']}, {'name': 'Pacritinib', 'type': 'DRUG', 'otherNames': ['VONJO'], 'description': 'Participants will receive pacritinib 200 mg twice daily.', 'armGroupLabels': ['Selinexor 40 mg (Arm 2)', 'Selinexor 40 mg (Optional Expansion Arm)', 'Selinexor 60 mg (Arm 1)', 'Selinexor 60 mg (Optional Expansion Arm)']}, {'name': 'Momelotinib', 'type': 'DRUG', 'otherNames': ['OJJAARA'], 'description': 'Participants will receive momelotinib 200 mg once daily.', 'armGroupLabels': ['Selinexor 40 mg (Arm 2)', 'Selinexor 40 mg (Optional Expansion Arm)', 'Selinexor 60 mg (Arm 1)', 'Selinexor 60 mg (Optional Expansion Arm)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Haris Ali', 'role': 'CONTACT', 'email': 'harisali@coh.org', 'phone': '6263564673'}, {'name': 'Haris Ali', 'role': 'CONTACT'}], 'facility': 'City of Hope - Duarte Main Site', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '21044', 'city': 'Columbia', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mohit Narang', 'role': 'CONTACT', 'email': 'mohit.narang@usoncology.com', 'phone': '304-942-9220'}, {'name': 'Mohit Narang', 'role': 'CONTACT'}], 'facility': 'Maryland Oncology Hematology - Independent of SCRI/ US Oncology', 'geoPoint': {'lat': 39.24038, 'lon': -76.83942}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ellen Ritche', 'role': 'CONTACT', 'email': 'ritchie@med.cornell.edu', 'phone': '646-962-4580'}, {'name': 'Ellen Ritche', 'role': 'CONTACT'}], 'facility': 'Weill Cornell Medicine NewYork-Presbyterian', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lindsay Rein', 'role': 'CONTACT', 'email': 'lindsay.magura@duke.edu', 'phone': '919-684-8964'}, {'name': 'Lindsay Rein', 'role': 'CONTACT'}], 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Aaron Gerds', 'role': 'CONTACT', 'email': 'gerdsa@ccf.org', 'phone': '216-445-9840'}, {'name': 'Aaron Gerds', 'role': 'CONTACT'}], 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Srinivas Tantravahi', 'role': 'CONTACT', 'email': 'Srinivas.Tantravahi@hci.utah.edu', 'phone': '801-213-6170'}, {'name': 'Srinivas Tantravahi', 'role': 'CONTACT'}], 'facility': 'Huntsman Cancer Institute', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '9000', 'city': 'Ghent', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Dominiek Mazure', 'role': 'CONTACT', 'email': 'dominiek.mazure@uzgent.be', 'phone': '+32 9 332 21 25'}, {'name': 'Dominiek Mazure', 'role': 'CONTACT'}], 'facility': 'UZ Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '3000', 'city': 'Leuven', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Timothy Devos', 'role': 'CONTACT', 'email': 'timothy.devos@uzleuven.be', 'phone': '+32 (0) 16 346880'}, {'name': 'Timothy Devos', 'role': 'CONTACT'}], 'facility': 'UZ Leuven - 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