A Study to Evaluate Single Agent Selinexor Versus Physician's Choice in Participants With Previou… (NCT04562870) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study to Evaluate Single Agent Selinexor Versus Physician's Choice in Participants With Previously Treated Myelofibrosis
United States, China112 participantsStarted 2021-03-17
Plain-language summary
This is a Phase 2, multicenter, two-arm, open-label study to evaluate the safety and efficacy of selinexor versus treatment per physician's choice (PC) in participants with myelofibrosis (MF) who had at least 6 months of treatment with a Janus kinase (JAK)1/2 inhibitor. Study participants will be randomized in a 1:1 ratio to either receive selinexor or physicians' choice of treatment.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* A diagnosis of primary MF or post-essential thrombocythemia (ET) or post-polycythemia (PV) MF according to the 2016 World Health Organization (WHO) classification of myeloproliferative neoplasms (MPN), by the most recent local pathology report.
* Previous treatment with JAK inhibitors for at least 6 months.
* Measurable splenomegaly during the screening period as demonstrated by spleen volume of ≥450 centimeter cube (cm\^3) by magnetic resonance imaging (MRI) or computerized tomography (CT) scan.
* Relapsed, Refractory or Intolerant to JAK inhibitors as defined as meeting one of the criteria below:
* less than (\<) 35% spleen volume reduction by MRI or CT-scan (from baseline) or
* \<50% decrease in spleen size by palpation (from baseline) or an increase of at least 3 cm with the spleen at least 5 cm below the left costal margin or
* Spleen volume increase greater than (\>) 25% from nadir or a return to within 10% of baseline after any initial response or
* Treatment with JAK inhibitor was complicated by development of red blood cells (RBC) transfusion requirement (2 units per month for 2 month); or grade 3 thrombocytopenia, anemia, hematoma/hemorrhage; or grade 2 non-hematologic toxicity while on JAK inhibitors
* Participants ≥18 years of age.
* Eastern Cooperative Oncology Group (ECOG) less than or equal to (≤) 2.
* Platelet count ≥75\*10\^9 per liter (/L).
* Absolute neutrophil count (ANC) ≥1.5\*10\^9/L.
* Serum direct bilirubin ≤1.5\*upper l…
What they're measuring
1
Percentage of Participants with Spleen Volume Reduction of Greater Than or Equal to (≥) 35 Percent (%) (SVR35)