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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline up to end of last cycle (approximately 48 months)
Awards & highlights
Study Summary
This trial is testing a new drug, selinexor, to see if it is better than the current standard of care for myelofibrosis.
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 belowSelect...
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.
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline up to end of last cycle (approximately 48 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline up to end of last cycle (approximately 48 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants with Spleen Volume Reduction of Greater Than or Equal to (≥) 35 Percent (%) (SVR35) Assessed by Independent Review Committee (IRC)
Secondary outcome measures
Duration of Spleen Volume Reduction of ≥25% (SVR25) Assessed by IRC
Duration of Spleen Volume Reduction of ≥35% (SVR35) Assessed by IRC
Duration of Total Symptom Score is ≥50% (TSS50) Based on Local Assessment
+8 moreSide effects data
From 2017 Phase 2 trial • 116 Patients • NCT0202598581%
Nausea
76%
Decreased Appetite
67%
Fatigue
62%
Vomiting
52%
Weight Decreased
52%
Constipation
48%
Diarrhoea
43%
Anaemia
33%
Vision Blurred
33%
Dyspnoea
29%
Asthenia
29%
Oedema Peripheral
24%
Hypokalaemia
24%
Abdominal Pain
19%
Dysgeusia
19%
Thrombocytopenia
19%
Dizziness
14%
Arthralgia
14%
Deep Vein Thrombosis
14%
Pyrexia
14%
Stomatitis
14%
Cough
14%
Abdominal Pain Upper
14%
Dehydration
14%
Insomnia
14%
Hypotension
14%
Hot Flush
10%
Night Sweats
10%
Bronchitis
10%
Abdominal Discomfort
10%
Pulmonary Embolism
10%
Osteoarthritis
10%
Skin Fissures
10%
Urinary Tract Infection
10%
Nasopharyngitis
10%
Anxiety
10%
Abdominal Distension
10%
Dry Mouth
10%
Hyperkalaemia
10%
Cataract
10%
Muscle Spasms
10%
Hyponatraemia
10%
Confusional State
5%
Haematuria
5%
Headache
5%
Dry Eye
5%
Pain In Extremity
5%
Face Oedema
5%
Oropharyngeal Pain
5%
Small Intestinal Obstruction
5%
Ileus
5%
Cognitive Disorder
5%
Dyspnoea Exertional
5%
Vertigo
5%
Procedural Pain
5%
Intestinal Obstruction
5%
Visual Impairment
5%
Malaise
5%
Depression
5%
Escherichia Infection
5%
Gastrointestinal Disorder
5%
Obstruction Gastric
5%
Pneumothorax
5%
Ascites
5%
Abdominal Pain Lower
5%
Gastrooesophageal Reflux Disease
5%
General Physical Health Deterioration
5%
Hypomagnesaemia
5%
Hyperglycaemia
5%
Cystitis
5%
Back Pain
5%
Musculoskeletal Chest Pain
5%
Vaginal Haemorrhage
5%
Pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part 2: Cohort A-Ovarian Carcinoma Schedule 1: Selinexor up to 50 mg/m^2 BIW
Part 2: Cohort A-Ovarian Carcinoma Schedule 2: Selinexor up to 60 mg/m^2 QW
Part 1: Cohort B-Endometrial Carcinoma: Selinexor up to 60 mg/m^2 BIW
Part 1: Cohort C-Cervical Carcinoma: Selinexor up to 60 mg/m^2 BIW
Part 1: Cohort A-Ovarian Carcinoma: Selinexor up to 60 mg/m^2 BIW
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 in first 2 cycles followed by selinexor 60 mg 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 2
~1360
Find a Location
Who is running the clinical trial?
Karyopharm Therapeutics IncLead Sponsor
87 Previous Clinical Trials
7,467 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
In what regions is this experiment accessible?
"At this moment in time, 10 different clinical sites are hosting the trial. These include Fairfax and Tyler as well as 8 other cities. To minimize travel demands, it is suggested to choose the closest location to join."
Answered by AI
Would this be considered a pioneering trial?
"Since its initial study, sponsored by Karyopharm Therapeutics Inc., in 2014 (involving 16 patients), Selinexor has received Phase 1 approval and is now being studied as part of 48 different live trials across 259 locations spanning 28 nations."
Answered by AI
Are researchers currently looking to enroll participants in this experiment?
"According to the clinicaltrials.gov page, this trial is still recruiting participants. This research program was initially posted on 17th March 2021 and underwent its most recent edit on 15th November 2022."
Answered by AI
What risks may be associated with utilizing Selinexor therapeutically?
"Our internal assessment of Selinexor's safety was a 2 due to Phase 2 trial data, which reveals some evidence of the drug's security but no proof of its efficacy."
Answered by AI
Are there any precedents for the use of Selinexor in clinical trials?
"At this moment, 48 clinical trials are running for Selinexor. Out of those studies, 4 have reached Phase 3. In total, 922 sites across the world are conducting research on these treatments; however, most of them are based in Bethesda MD."
Answered by AI
Who else is applying?
What state do they live in?
Colorado
What site did they apply to?
University of New Mexico CCC /NMCCA
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2
Why did patients apply to this trial?
Trying to improve my chances with PMF.
PatientReceived no prior treatments
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