Your session is about to expire
← Back to Search
Selective Inhibitor of Nuclear Export (SINE)
Selinexor for Myelofibrosis
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.
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.
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.
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 belowSelect...
My spleen is enlarged, measuring over 450 cm^3 on an MRI or CT scan.
Select...
My kidneys are functioning well enough for treatment.
Select...
I am able to get out of my bed or chair and move around.
Select...
I have been diagnosed with a specific type of blood cancer (MF, post-ET MF, or post-PV MF) as per WHO guidelines.
Select...
I am 18 years old or older.
Select...
I have been treated with JAK inhibitors for at least 6 months.
Select...
I am 18 years old or older.
Select...
I have been diagnosed with a specific type of blood cancer according to the latest WHO guidelines.
Select...
I can take care of myself and am up and about more than 50% of my waking hours.
Select...
My spleen is enlarged, measuring over 450 cm^3 on an MRI or CT scan.
Select...
I have been treated with JAK inhibitors for at least 6 months.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have severe GI issues that could affect medication absorption.
Select...
I haven't taken strong CYP3A affecting drugs within the last week.
Select...
My blood or bone marrow has a high number of immature cells.
Select...
I am not pregnant or breastfeeding.
Select...
I am not allergic or unable to take selinexor or the drugs in the study.
Select...
I have been treated with selinexor or similar drugs before.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2022 Phase 3 trial • 402 Patients • NCT0311056250%
Thrombocytopenia
45%
Anaemia
39%
Nausea
29%
Decreased appetite
29%
Diarrhoea
27%
Weight decreased
24%
Neuropathy peripheral
24%
Vomiting
23%
Fatigue
21%
Neutropenia
21%
Cataract
15%
Asthenia
12%
Upper respiratory tract infection
11%
Pyrexia
11%
Constipation
8%
Oedema peripheral
8%
Pneumonia
6%
Lymphopenia
6%
Dizziness
6%
Insomnia
6%
Dehydration
6%
Back pain
6%
Leukopenia
6%
Bronchitis
6%
Cough
5%
Acute kidney injury
5%
Abdominal pain
5%
Muscular weakness
5%
Lower respiratory tract infection
3%
Pain in extremity
3%
Sepsis
3%
Hyperglycaemia
3%
Urinary tract infection
3%
Nasopharyngitis
3%
Hyponatraemia
3%
Toothache
3%
Disturbance in attention
3%
Cardiac failure
3%
Hypertension
2%
Peripheral swelling
2%
Haemoglobin decreased
2%
Blood uric acid increased
2%
Cardiac failure acute
2%
Pulmonary contusion
2%
Embolism
2%
Blood creatinine increased
2%
Paraesthesia
2%
Infection
2%
Respiratory syncytial virus infection
2%
Dyspepsia
2%
Syncope
2%
Clostridium difficile infection
2%
Compression fracture
2%
Multiple fractures
2%
Myocardial infarction
2%
C-reactive protein increased
2%
Cerebral haemorrhage
2%
Ischaemic stroke
2%
Sudden death
2%
Oropharyngeal pain
2%
Cognitive disorder
2%
Confusional state
2%
Influenza
2%
Septic shock
2%
Osteonecrosis of jaw
2%
Taste disorder
2%
Hyperkalaemia
2%
Depression
2%
Cerebrovascular accident
2%
Bronchitis viral
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
~1730
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.
Targeting myeloproliferative neoplasms with JAK inhibitors.
Find a Location
Who is running the clinical trial?
Karyopharm Therapeutics IncLead Sponsor
88 Previous Clinical Trials
7,461 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a man who will use effective birth control during and for 3 months after the study, and won't donate sperm.My spleen is enlarged, measuring over 450 cm^3 on an MRI or CT scan.I have hepatitis C but my viral load is undetectable.I am a woman who can have children, not pregnant, and will use birth control during and after the study.My kidneys are functioning well enough for treatment.I am able to get out of my bed or chair and move around.I do not have severe GI issues that could affect medication absorption.I have HIV with a CD4 count ≥350, undetectable viral load, and no recent AIDS-related infections.I have hepatitis B but have been on antiviral therapy for over 8 weeks and my viral load is under 100 IU/mL.My condition worsened or didn't improve significantly on JAK inhibitors.I have hepatitis B but have been on antiviral therapy for over 8 weeks and my viral load is under 100 IU/mL.I have HIV with a CD4 count ≥350, undetectable viral load, and no recent AIDS-related infections.I have been diagnosed with a specific type of blood cancer (MF, post-ET MF, or post-PV MF) as per WHO guidelines.I am not pregnant, can use birth control during the study, and am under 50 or cannot have children.I am a man who will use effective birth control during and for 3 months after the study.I haven't taken any standard or experimental treatments for myelofibrosis in the last 21 days, except for hydroxyurea or growth factors.I am 18 years old or older.I have been treated with JAK inhibitors for at least 6 months.I haven't taken strong CYP3A affecting drugs within the last week.I haven't needed strong IV drugs for an infection in the last week.I have hepatitis C but my viral load is undetectable.I am 18 years old or older.I have not had major surgery in the last 4 weeks.I have been diagnosed with a specific type of blood cancer according to the latest WHO guidelines.I can take care of myself and am up and about more than 50% of my waking hours.My blood or bone marrow has a high number of immature cells.I am not pregnant or breastfeeding.I am not allergic or unable to take selinexor or the drugs in the study.I have been treated with selinexor or similar drugs before.My spleen is enlarged, measuring over 450 cm^3 on an MRI or CT scan.I have been treated with JAK inhibitors for at least 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Arm PC: Physician's Choice Treatment
- Group 2: Arm S: Selinexor
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.