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New treatment option for Myelofibrosis
Official title A Study of Selinexor Monotherapy in Subjects With JAK Inhibitor-naïve Myelofibrosis and Moderate Thrombocytopenia
ClinicalTrials.gov ID: NCT05980806
What this study is testing
What is Selinexor 60 mg?
Selinexor 60 mg is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for myelofibrosis.
Also referred to as KPT-330.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The main purpose of this study is to evaluate the efficacy of selinexor in JAKi-naïve participants with myelofibrosis (MF) and with normal platelet counts or with mild to moderate thrombocytopenia based on spleen volume reduction (SVR). Additional efficacy and safety parameters will also be assessed during the study.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Measurable splenomegaly during the screening period as demonstrated by spleen volume of greater than or equal to (\>=) 450 cubic square centimeter...
- DIPSS risk category of intermediate-1 with symptoms, or intermediate-2, or high-risk
- ECOG Performance Status less than or equal to (\<=) 2
- Platelet count of greater than or equal to (\>=) 50 x 10\^9/L without platelet transfusion within 7 days prior to the first dose of selinexor
You likely can't join if
- More than 10% blasts in peripheral blood or bone marrow (accelerated or blast phase)
- Previous treatment with JAK inhibitors for MF
- Previous treatment with selinexor or other XPO1 inhibitors
- Females who are pregnant or lactating
- Prior splenectomy, splenic radiation, or a splenic embolization within 6 months prior to C1D1
- History of myocardial infarction, unstable angina, percutaneous transluminal coronary angioplasty (PTCA), coronary artery bypass graft (CABG)...
See the full eligibility criteria
- 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
- Measurable splenomegaly during the screening period as demonstrated by spleen volume of greater than or equal to (\>=) 450 cubic square centimeter (cm\^3) by MRI or CT scan (results from MRI or CT imaging performed...
- DIPSS risk category of intermediate-1 with symptoms, or intermediate-2, or high-risk
- ECOG Performance Status less than or equal to (\<=) 2
- Platelet count of greater than or equal to (\>=) 50 x 10\^9/L without platelet transfusion within 7 days prior to the first dose of selinexor
- Absolute neutrophil count (ANC) \>=1.0 × 10\^9/L without need for growth factors within 7 days prior to the first dose of selinexor
- Adequate liver function as defined by the following: aspartate transaminase (AST) and alanine transaminase (ALT) \<= 2.5 × upper limit normal (ULN) and serum total bilirubin \<= 3×ULN
- Calculated creatinine clearance (CrCl) greater than (\>) 15 milliliter per minute (mL/min) based on the Cockcroft and Gault formula
- Active symptoms of MF as determined by presence of at least 2 symptoms with an average score \>= 5 or total score of \>= 12 at screening (at least 5 of 7 consecutive days immediately preceding C1D1) using the MFSAF V4.0
- Must provide bone marrow biopsy samples (samples obtained up to 3 months prior to C1D1 are permitted) at screening and during the study
- Currently not eligible for stem cell transplantation
- Must be willing to complete the MFSAF V4.0 daily during the study for evaluating the symptom response (i.e., TSS50) Key
- More than 10% blasts in peripheral blood or bone marrow (accelerated or blast phase)
- Previous treatment with JAK inhibitors for MF
- Previous treatment with selinexor or other XPO1 inhibitors
- Females who are pregnant or lactating
- Prior splenectomy, splenic radiation, or a splenic embolization within 6 months prior to C1D1
- History of myocardial infarction, unstable angina, percutaneous transluminal coronary angioplasty (PTCA), coronary artery bypass graft (CABG), cerebrovascular accident (transient ischemic attack [TIA]), ventricular...
- Unable to tolerate two forms of antiemetics prior to each dose for the first two cycles
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Columbia, Maryland, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Cleveland, Ohio, United States
- Houston, Texas, United States
- Salt Lake City, Utah, United States
- Ghent, Belgium
- Leuven, Belgium
- Plovdiv, Bulgaria
- Sofia, Bulgaria
- Stara Zagora, Bulgaria
- Montreal, Quebec, Canada
- Olomouc, Czechia
- Aarhus N, Central Jutland, Denmark
- Bordeaux, Aquitaine, France
- Pierre-Bénite, Auvergne-Rhône-Alpes, France
- Tours, Indre-et-Loire, France
- Nîmes, Occitanie, France
- Angers, Pays de la Loire Region, France
+ 43 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Columbia, Maryland, United States; New York, New York, United States; Durham, North Carolina, United States; Cleveland, Ohio, United States; Houston, Texas, United States and 57 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.