All > Myelofibrosis > Polycythemia Vera

Selinexor for Primary Myelofibrosis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Huntsman Cancer Institute/University of Utah, Salt Lake City, UTPrimary Myelofibrosis+2 MoreSelinexor - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug for people with myelofibrosis who can't take other treatments.

Eligible Conditions
  • Primary Myelofibrosis
  • Post-essential Thrombocythemia Myelofibrosis
  • Post Polycythemia Vera Myelofibrosis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
Metronomic dosing
1
Selinexor
1
Selinexor

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Up to 24 months

Up to 24 months
Overall Survival
Up to 6 months
Adverse Events that Occur
Change in spleen volume
Change in symptoms score
Overall response

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Metronomic dosing
1
Selinexor
1
Selinexor

Side Effects for

Phase 3 Double-blinded: Selinexor
81%Nausea
77%Decreased appetite
51%Fatigue
50%Vomiting
49%Anaemia
43%Weight decreased
40%Constipation
40%Diarrhoea
39%Thrombocytopenia
31%Asthenia
28%Hyponatraemia
27%Dysgeusia
26%Abdominal pain
24%Dizziness
22%Vision blurred
22%Vision Blurred
22%Hypercreatininaemia
20%Neutropenia
16%Cough
16%Oedema peripheral
14%Back pain
14%Leukopenia
13%Hypomagnesaemia
12%Headache
12%Hypertension
12%Hypotension
11%Hypokalaemia
11%Hyperglycaemia
11%Insomnia
11%Pyrexia
10%Dyspepsia
9%Alanine aminotransferase increased
7%Blood alkaline phosphatase increased
7%Hypophosphataemia
7%Lymphopenia
7%Urinary tract infection
7%Hyperkalaemia
7%Night sweats
6%Abdominal distension
6%Gastroesophageal reflux disease
6%Muscle spasms
6%Syncope
6%Dry mouth
6%Gastrooesophageal reflux disease
6%Chills
6%Aspartate aminotransferase increased
6%Dehydration
6%Muscular weakness
6%Pain in extremity
6%Depression
5%Visual Impairement
5%Flatulence
5%Myalgia
5%Photopsia
5%Hypoalbuminaemia
5%Arthralgia
4%Hypocalcaemia
4%Taste disorder
4%Nasal congestion
4%Cataract
4%Haematuria
4%Oropharyngeal pain
4%Sinus Tachycardia
3%Hyperuricaemia
3%Pulmonary embolism
3%Dyspnoea
3%Electrocardiogram QT prolonged
3%Anxiety
3%Epistaxis
3%International normalised ratio increased
3%Sinus tachycardia
3%Non-cardiac chest pain
3%Hypochloraemia
3%Confusional state
3%Pollakiuria
3%Rash
2%Acute kidney injury
2%Pneumonia
2%Activated partial thromboplastin time prolonged
2%Hyperbilirubinaemia
2%Hot flush
2%Pleural effusion
2%Tachycardia
2%Vertigo
2%Influenza like illness
2%Pain
1%Renal impairment
1%Small intestinal obstruction
1%Limb injury
1%Atrial fibrillation
1%Obstruction gastric
1%Rectal haemorrhage
1%Influenza
1%Device related infection
1%Escherichia infection
1%Anastomotic ulcer haemorrhage
1%Clavicle fracture
1%Head injury
1%Hip fracture
1%Wound complication
1%Transaminases increased
1%Myelodysplastic syndrome
1%Tumour pain
1%Cancer pain
1%Cerebrovascular accident
1%Pulmonary oedema
1%Venous thrombosis
1%General physical health deterioration
1%Gastrointestinal haemorrhage
1%Rhinitis
1%Septic shock
1%Fall
1%Pneumothorax
1%Peritonitis
1%Malnutrition
1%Sciatica
1%Febrile infection
1%Upper gastrointestinal haemorrhage
1%Large intestinal obstruction
1%Respiratory syncytial virus infection
1%Lung abscess
1%Spinal fracture
1%Suicide attempt
1%Sinusitis
1%Cardiac failure
1%Intra-abdominal haemorrhage
1%Device breakage
1%Mania
1%Acute respiratory failure
1%Small intestine obstruction
1%Dysphagia
1%Enterocutaneous fistula
1%Gastritis
1%Bronchitis viral
1%Cellulitis
1%Humerus fracture
1%Lethargy
1%Chronic obstructive pulmonary disease
1%Respiratory failure
1%Bile duct obstruction
1%Cholangitis
1%Malaise
1%Micturition urgency
This histogram enumerates side effects from a completed 2021 Phase 2 & 3 trial (NCT02606461) in the Phase 3 Double-blinded: Selinexor ARM group. Side effects include: Nausea with 81%, Decreased appetite with 77%, Fatigue with 51%, Vomiting with 50%, Anaemia with 49%.

Trial Design

1 Treatment Group

Selinexor, all patients
1 of 1

Experimental Treatment

56 Total Participants · 1 Treatment Group

Primary Treatment: Selinexor · No Placebo Group · Phase 2

Selinexor, all patients
Drug
Experimental Group · 1 Intervention: Selinexor · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Selinexor
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 24 months

Who is running the clinical trial?

University of UtahLead Sponsor
1,009 Previous Clinical Trials
1,787,532 Total Patients Enrolled
5 Trials studying Primary Myelofibrosis
795 Patients Enrolled for Primary Myelofibrosis
Karyopharm Therapeutics IncIndustry Sponsor
84 Previous Clinical Trials
8,002 Total Patients Enrolled
2 Trials studying Primary Myelofibrosis
349 Patients Enrolled for Primary Myelofibrosis
Srinivas Tantravahi, MDPrincipal InvestigatorUniversity of Utah

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are expected to live for at least 6 more months.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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