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Selective Inhibitor of Nuclear Export

Selinexor for Myelofibrosis (SENTRY-2 Trial)

Phase 2

Recruiting

Research Sponsored by Karyopharm Therapeutics Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Measurable splenomegaly with spleen volume >= 450 cm^3 by MRI or CT scan within 28 days prior to screening

ECOG Performance Status <= 2

Must not have

Previous treatment with JAK inhibitors for MF

Unable to tolerate two forms of antiemetics prior to each dose for the first two cycles

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to eos (approximately 48 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test how well a drug called selinexor works in people with myelofibrosis who have not tried a specific type of treatment before. The main goal is to see

Who is the study for?

This trial is for individuals with myelofibrosis who haven't been treated with JAK inhibitors and have moderate thrombocytopenia. They should have symptoms of myelofibrosis, measurable spleen enlargement, specific risk categories per DIPSS, an ECOG Performance Status of 2 or less, certain blood cell counts without transfusions or growth factors recently, and adequate liver function.

What is being tested?

The study tests the effectiveness of Selinexor in reducing spleen volume in patients new to JAK inhibitor treatment for myelofibrosis with low platelet counts. It will compare different doses (40 mg and 60 mg) against other treatments like Pacritinib and Momelotinib.

What are the potential side effects?

Selinexor may cause side effects such as nausea, vomiting, diarrhea, loss of appetite, weight loss, fatigue, low blood count levels which can increase infection risk; it might also affect liver enzymes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My spleen is enlarged, measuring over 450 cm^3 on a recent scan.

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I am able to care for myself and up and about more than 50% of my waking hours.

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My platelet count is between 50 and 100, without recent transfusions.

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My liver tests are within the required range.

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I have moderate to severe symptoms of myelofibrosis.

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I am not eligible for a stem cell transplant.

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My condition is confirmed as MF or has progressed from ET or PV, according to the latest WHO guidelines.

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My condition is classified as intermediate-1 with symptoms, intermediate-2, or high-risk.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with JAK inhibitors for myelofibrosis.

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I can't tolerate two different anti-nausea medications for the first two treatment cycles.

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I have been treated with selinexor or similar drugs before.

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I am not pregnant or breastfeeding.

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I haven't had major heart or stroke issues in the last 6 months.

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I had my spleen removed or received spleen radiation within the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to eos (approximately 48 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to eos (approximately 48 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to eos (approximately 48 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of Participants with Spleen Volume Reduction 35 (SVR35) at Week 24.

Secondary study objectives

Proportion of Participants with SVR35 at Any Time Point.

Proportion of Participants with TSS50 at Any Time.

Proportion of Participants with Total Symptom Score 50 (TSS50) at Week 24.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Selinexor 60 mg (Optional Expansion Arm)Experimental Treatment4 Interventions

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 \[g/dL\]).

Group II: Selinexor 60 mg (Arm 1)Experimental Treatment4 Interventions

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.

Group III: Selinexor 40 mg (Optional Expansion Arm)Experimental Treatment4 Interventions

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).

Group IV: Selinexor 40 mg (Arm 2)Experimental Treatment4 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Momelotinib

2013

Completed Phase 3

~1060

Ruxolitinib

2018

Completed Phase 3