Status:
RECRUITING
A Study of Selinexor Monotherapy in Subjects with JAK Inhibitor-naïve Myelofibrosis and Moderate Thrombocytopenia
Lead Sponsor:
Karyopharm Therapeutics Inc
Conditions:
Myelofibrosis
Moderate Thrombocytopenia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- Key
- 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 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).
- Participants with 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 50 to less than (\<) 100 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 aminotransferase (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 a score \>= 3 or total score of \>= 10 at screening using the MFSAF V4.0.
- Participants must provide bone marrow biopsy samples (samples obtained up to 3 months prior to C1D1 are permitted) at screening and during the study.
- Participants currently not a candidate for stem cell transplantation.
- Participants must be willing to complete the MFSAF V4.0 daily during the study for evaluating the symptom response (i.e., TSS50).
- Key
Exclusion
- 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.
- Female participants who are pregnant or lactating.
- Prior splenectomy, or splenic radiation within 6 months prior to C1D1.
- 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.
- Participants unable to tolerate two forms of antiemetics prior to each dose for the first two cycles.
Key Trial Info
Start Date :
April 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2028
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT05980806
Start Date
April 22 2024
End Date
October 1 2028
Last Update
February 5 2025
Active Locations (48)
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1
City of Hope - Duarte Main Site
Duarte, California, United States, 91010
2
Maryland Oncology Hematology - Independent of SCRI/ US Oncology
Columbia, Maryland, United States, 21044
3
Weill Cornell Medicine NewYork-Presbyterian
New York, New York, United States, 10021
4
Duke University
Durham, North Carolina, United States, 27705