Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
- - Diagnosis of primary MF or post-essential thrombocythemic or post-polycythemia according to the 2016 world health organization (WHO) classification of MPN confirmed by the most recent local pathology report.
- - Measurable splenomegaly during the screening period as demonstrated by spleen volume of ≥450 cubic centimeter (cm^3) by MRI or CT-scan.
- - Participants with dynamic international prognostic scoring system (DIPSS) risk category of intermediate-1, intermediate-2, or high-risk.
- - Participants ≥18 years of age.
- - Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to (≤) 2.
- - Platelet count ≥100 * 10^9/Liter (L).
- - Absolute neutrophil count (ANC) ≥1.5 * 10^9/L.
- - Serum direct bilirubin ≤1.5 * upper limit of normal (ULN); Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 * ULN.
- - Creatinine clearance (CrCl) greater than (>) 15 milliliters per minute (mL/min) based on the Cockcroft and Gault formula.
- - Participants with active hepatitis B virus (HBV) are eligible if antiviral therapy for hepatitis B has been given for >8 weeks and viral load is less than (<) 100 international units/milliliter (IU/mL).
- - Participants with untreated hepatitis C virus (HCV) are eligible there is documentation of negative viral load per institutional standard.
- - Participants with history of human immunodeficiency virus (HIV), are eligible if participants have cluster of differentiation 4 (CD4)+ T-cell counts ≥350 cells/microliter, negative viral load per institutional standard, and no history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections in the last year.
- - Female participants of childbearing potential must have a negative serum pregnancy test at screening and agree to use highly effective methods of contraception throughout the study and for one month following the last dose of study treatment.
- - Male participants who are sexually active must use highly effective methods of contraception throughout the study and for one month following the last dose of study treatment.
- - Participants must sign the written informed consent in accordance with federal, local and institutional guidelines.
- - >5% blasts in peripheral blood or >10% blasts in bone marrow (accelerated phase).
- - Received previous treatment with Janus kinase (JAK) inhibitors for MF (treatment with hydroxyurea for up to 2 weeks is allowed).
- - Previous treatment with selinexor or other exportin-1 (XPO1) inhibitors.
- - Impairment of gastrointestinal (GI) function or GI disease that could significantly alter the absorption of selinexor.
- - Received strong cytochrome P450 3A (CYP3A) inhibitors ≤7 days prior to selinexor dosing or strong CYP3A inducers ≤14 days prior to selinexor dosing.
- - Major surgery <28 days prior to cycle 1 day 1 (C1D1).
- - Uncontrolled (i.e. clinically unstable) infection requiring parenteral antibiotics, antivirals, or antifungals within 7 days prior to first dose of study treatment; however, prophylactic use of these agents is acceptable (including parenteral).
- - Any life-threatening illness, medical condition, or organ system dysfunction which, in the Investigator's opinion, could compromise the patient's safety, prevent the patient from giving informed consent, or being compliant with the study procedures.
- - Female participants who are pregnant or lactating.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
|Phase 1/Phase 2|
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Karyopharm Therapeutics Inc|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
Experimental: Phase 1a: Cohort 1: Selinexor 40 mg and Ruxolitinib 15/20 mg
Participants with MF will receive a dose of 40 milligrams (mg) of selinexor oral tablets once weekly (QW) on Days 1, 8, 15, and 22 of each 28-day cycle and ruxolitinib oral tablets 15 or 20 mg twice a day (BID).
Experimental: Phase 1a: Cohort 2: Selinexor 60 mg and Ruxolitinib 15/20 mg
Participants with MF will receive a dose of 60 mg of selinexor oral tablets QW on Days 1, 8, 15, and 22 of each 28-day cycle and ruxolitinib oral tablets 15 or 20 mg BID.
Experimental: Phase 1a: Cohort -1: Selinexor 20 mg and Ruxolitinib 15/20 mg
Participants with MF will receive a dose of 20 mg of selinexor oral tablet twice weekly (BIW) of each 28-day cycle and ruxolitinib oral tablets 15 or 20 mg BID.
Experimental: Phase 1b: RP2D: Selinexor and Ruxolitinib 15/20 mg
Participants with MF will receive recommended safe dose (estimated in Phase 1a) of selinexor oral tablets on Days 1, 8, 15, and 22 of each 28-day cycle and ruxolitinib oral tablets 15 or 20 mg BID.
Experimental: Phase 2: Selinexor RP2D and Ruxolitinib 15/20 mg
Participants with MF will receive recommended safe dose (estimated in Phase 1b) of selinexor oral tablets QW on Days 1, 8, 15, and 22 of each 28-day cycle and ruxolitinib oral tablets 15 or 20 mg BID.
Active Comparator: Phase 2: Ruxolitinib 15/20 mg
Participants with MF will receive ruxolitinib oral tablets 15 or 20 mg BID.
Drug: - Selinexor
Formulation: 20 mg Tablet; Dose: 20, 40 (2 tablets of 20 mg), 60 mg (3 tablets of 20 mg); Route of Administration: Oral
Drug: - Ruxolitinib
Formulation: 5, 10 mg Tablet; Dose: 15, 20 mg; Route of Administration: Oral
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.