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Selective Inhibitor of Nuclear Export (SINE)

Selinexor for Myelofibrosis

Orbassano, Italy
Phase 2
Waitlist Available
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 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
Calculated creatinine clearance (CrCl) >15 milliliter (mL)/minute (min) based on the Cockcroft and Gault formula.
Must not have
Impairment of gastrointestinal (GI) function or GI disease that could significantly alter the absorption of selinexor (Example: vomiting, or diarrhea that is Common Terminology Criteria for Adverse Events (CTCAE) grade >1)
Received strong cytochrome P450 3A (CYP3A) inhibitors ≤7 days prior to selinexor dosing or strong CYP3A inducers ≤14 days prior to selinexor dosing
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing selinexor, a medication that aims to stop harmful cells from growing, in patients with myelofibrosis. Selinexor is the first oral selective inhibitor of nuclear export compound tested for cancer treatment, showing broad antitumor activity. These patients have already tried another treatment for a significant period without full success. The study will compare selinexor to other treatments chosen by doctors to see which works better.

See full description
Who is the study for?
Adults diagnosed with myelofibrosis who have been treated with JAK inhibitors for at least 6 months can join. They must be in good general health, not pregnant or breastfeeding, and willing to use contraception. People cannot join if they have a high percentage of blasts in blood or bone marrow, severe gastrointestinal issues affecting drug absorption, recent major surgery, life-threatening conditions, or previous treatment with selinexor.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of Selinexor compared to other treatments chosen by physicians for those with myelofibrosis previously treated with JAK inhibitors. Participants will be randomly assigned to either receive Selinexor or a physician's choice treatment in an open-label study.See study design
What are the potential side effects?
Selinexor may cause side effects such as nausea, vomiting, diarrhea (if severe), fatigue, blood count changes that could lead to increased risk of infections or bleeding problems. The exact side effects depend on individual reactions and the specific treatments used in the physician's choice group.

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 an MRI or CT scan.
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My kidneys are functioning well enough for treatment.
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I am able to get out of my bed or chair and move around.
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I have been diagnosed with a specific type of blood cancer (MF, post-ET MF, or post-PV MF) as per WHO guidelines.
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I am 18 years old or older.
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I have been treated with JAK inhibitors for at least 6 months.
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I am 18 years old or older.
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I have been diagnosed with a specific type of blood cancer according to the latest WHO guidelines.
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I can take care of myself and am up and about more than 50% of my waking hours.
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My spleen is enlarged, measuring over 450 cm^3 on an MRI or CT scan.
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I have been treated with JAK inhibitors for at least 6 months.
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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have severe GI issues that could affect medication absorption.
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I haven't taken strong CYP3A affecting drugs within the last week.
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My blood or bone marrow has a high number of immature cells.
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I am not pregnant or breastfeeding.
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I am not allergic or unable to take selinexor or the drugs in the study.
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I have been treated with selinexor or similar drugs before.
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Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2022 Phase 3 trial • 402 Patients • NCT03110562
50%
Thrombocytopenia
45%
Anaemia
39%
Nausea
29%
Diarrhoea
29%
Decreased appetite
27%
Weight decreased
24%
Neuropathy peripheral
24%
Vomiting
23%
Fatigue
21%
Cataract
21%
Neutropenia
15%
Asthenia
12%
Upper respiratory tract infection
11%
Pyrexia
11%
Constipation
8%
Pneumonia
8%
Oedema peripheral
6%
Dizziness
6%
Insomnia
6%
Dehydration
6%
Back pain
6%
Lymphopenia
6%
Leukopenia
6%
Bronchitis
6%
Cough
5%
Acute kidney injury
5%
Lower respiratory tract infection
5%
Abdominal pain
5%
Muscular weakness
3%
Pain in extremity
3%
Hyperglycaemia
3%
Urinary tract infection
3%
Hyponatraemia
3%
Nasopharyngitis
3%
Toothache
3%
Disturbance in attention
3%
Sepsis
3%
Cardiac failure
3%
Hypertension
2%
Respiratory syncytial virus infection
2%
Peripheral swelling
2%
Blood creatinine increased
2%
Paraesthesia
2%
Compression fracture
2%
Blood uric acid increased
2%
Dyspepsia
2%
Syncope
2%
Osteonecrosis of jaw
2%
Infection
2%
Cerebral haemorrhage
2%
Ischaemic stroke
2%
Sudden death
2%
Cognitive disorder
2%
Confusional state
2%
Myocardial infarction
2%
C-reactive protein increased
2%
Haemoglobin decreased
2%
Septic shock
2%
Taste disorder
2%
Hyperkalaemia
2%
Influenza
2%
Cardiac failure acute
2%
Depression
2%
Cerebrovascular accident
2%
Pulmonary contusion
2%
Bronchitis viral
2%
Embolism
2%
Oropharyngeal pain
2%
Clostridium difficile infection
2%
Multiple fractures
100%
80%
60%
40%
20%
0%
Study treatment Arm
SVdX Arm: Selinexor + Bortezomib + Dexamethasone
SdX Arm: Selinexor + Dexamethasone
SVd Arm: Selinexor + Bortezomib + Dexamethasone
Vd Arm: Bortezomib + Dexamethasone

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm S: SelinexorExperimental Treatment1 Intervention
Participants with MF who had previously received at least 6 months of treatment with JAK 1/2 inhibitor will receive a dose of selinexor 80 mg for first 2 cycles followed by selinexor 60 mg once weekly (QW) in subsequent cycles orally on Days 1, 8, 15, and 22 of each 28-day cycle to participants on Arm S.
Group II: Arm PC: Physician's Choice TreatmentActive Control1 Intervention
Participants with MF who had previously received at least 6 months of treatment with JAK 1/2 inhibitor will receive Physician's choice treatment which will be administered as per clinical practice.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Selinexor
2020
Completed Phase 3
~1760

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Myelofibrosis include JAK inhibitors such as ruxolitinib and fedratinib, and selective inhibitors of nuclear export like selinexor. JAK inhibitors work by blocking the Janus kinase (JAK) pathway, which is often overactive in Myelofibrosis, leading to reduced inflammation and spleen size, and improved symptoms. Selinexor, on the other hand, inhibits the export of tumor suppressor proteins from the nucleus, thereby promoting cancer cell death. These mechanisms are crucial for Myelofibrosis patients as they target the underlying disease processes, potentially improving survival and quality of life.
Targeting myeloproliferative neoplasms with JAK inhibitors.

Find a Location

Closest Location:Illinois Cancer Specialist· Niles, IL· 289 miles

Who is running the clinical trial?

Karyopharm Therapeutics IncLead Sponsor
88 Previous Clinical Trials
7,315 Total Patients Enrolled

Media Library

Selinexor (Selective Inhibitor of Nuclear Export (SINE)) Clinical Trial Eligibility Overview. Trial Name: NCT04562870 — Phase 2
Myelofibrosis Research Study Groups: Arm PC: Physician's Choice Treatment, Arm S: Selinexor
Myelofibrosis Clinical Trial 2023: Selinexor Highlights & Side Effects. Trial Name: NCT04562870 — Phase 2
Selinexor (Selective Inhibitor of Nuclear Export (SINE)) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04562870 — Phase 2
~22 spots leftby Mar 2026