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Selective Inhibitor of Nuclear Export (SINE)
Selinexor for Myelofibrosis (ESSENTIAL Trial)
Phase 2
Waitlist Available
Led By Srinivas Tantravahi, MD
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Diagnosis of primary myelofibrosis (PMF), post-essential thrombocytosis (PET-MF) or post-polycythemia vera (PPV-MF)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
ESSENTIAL Trial Summary
This trial is testing a new drug for people with myelofibrosis who can't take other treatments.
Who is the study for?
Adults diagnosed with primary or secondary myelofibrosis who haven't responded well to, or can't tolerate, JAK1/2 inhibitors like ruxolitinib. They should be relatively active (ECOG ≤ 2), have a spleen enlarged by at least 5 cm if symptomatic or 10 cm regardless of symptoms, and meet specific blood count and organ function criteria.Check my eligibility
What is being tested?
The trial is testing Selinexor's effectiveness and safety in patients with myelofibrosis who don't benefit from current treatments. It's an open-label study where all participants receive the drug; there's no comparison group.See study design
What are the potential side effects?
Selinexor may cause nausea, vomiting, diarrhea, loss of appetite, weight loss, fatigue, low blood counts leading to increased risk of infections or bleeding problems. Some people might also experience changes in liver enzymes indicating liver stress.
ESSENTIAL Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up and about more than 50% of my waking hours.
Select...
I have been diagnosed with a type of myelofibrosis.
ESSENTIAL Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in spleen volume
Secondary outcome measures
Adverse Events that Occur
Change in symptoms score
Overall Survival
+1 moreSide effects data
From 2017 Phase 2 trial • 116 Patients • NCT0202598578%
Decreased Appetite
65%
Fatigue
65%
Nausea
61%
Vomiting
57%
Weight Decreased
48%
Anaemia
43%
Thrombocytopenia
35%
Hypokalaemia
35%
Vision Blurred
30%
Asthenia
30%
Diarrhoea
26%
Constipation
22%
Dizziness
22%
Dysgeusia
22%
Hyponatraemia
22%
Hypomagnesaemia
17%
Dehydration
17%
Peripheral Sensory Neuropathy
13%
Malaise
13%
Dyspnoea
13%
Neutropenia
13%
Cystitis
13%
Back Pain
9%
Ear Discomfort
9%
Face Oedema
9%
Oedema Peripheral
9%
Pulmonary Embolism
9%
Syncope
9%
Cough
9%
Confusional State
9%
Auditory Disorder
9%
General Physical Health Deterioration
9%
Deep Vein Thrombosis
9%
Urinary Tract Infection
9%
Hyperglycaemia
9%
Pain In Extremity
9%
Hypotension
9%
Paraesthesia
4%
Infection
4%
Visual Impairment
4%
Insomnia
4%
Pneumonia
4%
Cataract
4%
Varicella Zoster Virus Infection
4%
Oropharyngeal Pain
4%
Vertigo
4%
Urosepsis
4%
Pyrexia
4%
Supraventricular Tachycardia
4%
Femoral Neck Fracture
4%
Depression
4%
Polyurea
4%
Hot Flush
4%
Headache
4%
Gait Disturbance
4%
Abdominal Pain
4%
Abdominal Distension
4%
Stomatitis
4%
Ascites
4%
Dry Mouth
4%
Abdominal Pain Lower
4%
Oral Candidiasis
4%
Arthralgia
4%
Vaginal Haemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
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 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 A-Ovarian Carcinoma: Selinexor up to 60 mg/m^2 BIW
ESSENTIAL Trial Design
1Treatment groups
Experimental Treatment
Group I: Selinexor, all patientsExperimental Treatment1 Intervention
Single Arm Study, all patients will get selinexor
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?
University of UtahLead Sponsor
1,099 Previous Clinical Trials
1,778,705 Total Patients Enrolled
5 Trials studying Primary Myelofibrosis
795 Patients Enrolled for Primary Myelofibrosis
Karyopharm Therapeutics IncIndustry Sponsor
87 Previous Clinical Trials
7,562 Total Patients Enrolled
3 Trials studying Primary Myelofibrosis
560 Patients Enrolled for Primary Myelofibrosis
Srinivas Tantravahi, MDPrincipal InvestigatorUniversity of Utah
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have recovered from previous cancer treatment side effects, or they are mild and stable.My blood, liver, and kidney functions are within normal ranges.I have not had major surgery in the last 4 weeks.My body surface area is less than 1.4 square meters.I do not have an active infection needing IV drugs within the last week.I have stopped taking certain medications as required and waited the necessary time before starting the study treatment.I have no stomach or bowel problems affecting my ability to swallow pills.I am breastfeeding and cannot stop during the study.I am 18 years old or older.I can take care of myself and am up and about more than 50% of my waking hours.I stopped taking Ruxolitinib or similar medications at least 3 days ago.I do not have an active hepatitis A, B, or C infection.I have been diagnosed with a type of myelofibrosis.I've been treated with ruxolitinib or similar drugs for over 3 months without enough improvement, and I still have significant spleen enlargement and symptoms.I agree to use two forms of birth control during and for 3 months after the study.I am a man and will use protection during sex with women who can have children.I haven't had cancer treatment in the last 2 weeks.I am allergic or cannot take certain medications needed for the trial.I have previously been treated with a SINE compound like selinexor.I am a woman who can have children and have a recent negative pregnancy test.
Research Study Groups:
This trial has the following groups:- Group 1: Selinexor, all patients
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.
Is this experiment the pioneering effort of its type?
"Since 2014, Selinexor has garnered considerable attention from the medical community. Karyopharm Therapeutics Inc. sponsored its first clinical trial in that year with 16 participants and eventually received Phase 1 drug approval following this initial study. Presently there are 48 ongoing trials for Selinexor across 259 cities and 28 nations worldwide."
Answered by AI
Is Selinexor deemed a secure option for individuals?
"There is preliminary clinical data verifying the safety of Selinexor, so it received a rating of 2."
Answered by AI
Are enrollment opportunities available for this trial at present?
"Affirmative. Clinicaltrials.gov data reveals that this research is presently recruiting participants, with the first post made on May 10th 2019 and last update on May 3rd 2022. 56 people are being admitted from a single clinical site."
Answered by AI
What prior experimental studies have been conducted using Selinexor?
"Currently, Selinexor has 48 ongoing clinical trials with 4 in the late-stage Phase 3. While Bethesda, Maryland is one of several research sites for this medication, it can be found at 922 locations worldwide."
Answered by AI
What is the current capacity for enrollees in this research protocol?
"Affirmative. The clinical trial listing on clinicaltrials.gov displays that recruitment for this study is currently underway; it was initially posted on May 10th 2019 and most recently modified on May 3rd 2022. 56 participants need to be recruited from a single location."
Answered by AI
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