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Janus Kinase (JAK) Inhibitor
Selinexor + Ruxolitinib for Myelofibrosis (SENTRY Trial)
Phase 3
Recruiting
Research Sponsored by Karyopharm Therapeutics Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants with international prognostic scoring system (DIPSS) risk category of intermediate-1, or intermediate-2, or high-risk.
A diagnosis of primary MF or post-essential thrombocythemia (ET) or postpolycythemia- vera (PV) MF according to the 2016 World Health Organization (WHO) classification of MPN, confirmed by the most recent local pathology report.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline up to eos (approximately 48 months)
Awards & highlights
SENTRY Trial Summary
This trial is testing a new combination drug therapy for myelofibrosis, a bone marrow cancer. The trial will have three phases, with the first two phases testing safety and preliminary efficacy in various doses, and the third phase testing efficacy in a randomized study.
Who is the study for?
Adults diagnosed with primary or secondary myelofibrosis, showing significant spleen enlargement and certain risk levels. They must have functioning major organs, no prior treatments with JAK inhibitors or selinexor, not be pregnant or breastfeeding, agree to use contraception, and have a life expectancy over 6 months. Exclusions include recent surgeries, uncontrolled infections without stable treatment for hepatitis B/C or HIV.Check my eligibility
What is being tested?
The trial is testing the combination of Selinexor and Ruxolitinib against a placebo plus Ruxolitinib in patients who haven't used JAK inhibitors before. It's split into two phases: an initial phase to determine safe dosages followed by a larger phase where participants are randomly assigned to either the drug combo or placebo in a 2:1 ratio.See study design
What are the potential side effects?
Potential side effects may include digestive issues like nausea and diarrhea; blood disorders such as low platelet counts; liver function abnormalities; fatigue; possible allergic reactions if sensitive to the drugs' components; and increased risk of infection due to immune system effects.
SENTRY Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition is classified as intermediate-1, intermediate-2, or high-risk according to DIPSS.
Select...
I have been diagnosed with a specific type of bone marrow disorder according to the latest standards.
Select...
My liver tests are within the normal range.
Select...
I have HIV with a CD4+ count >= 350, no AIDS infections in the last year, and have been on ART for at least 4 weeks.
Select...
I have significant symptoms of myelofibrosis according to the MFSAF V4.0.
Select...
I am not eligible for a stem cell transplant.
Select...
My spleen is enlarged, measuring over 450 cm^3 on a recent scan.
Select...
I had hepatitis C but have been treated and now have an undetectable viral load.
Select...
I am able to get out of my bed or chair and move around.
Select...
I am 18 years old or older.
Select...
My white blood cell count is healthy without needing medication to boost it.
SENTRY Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline up to eos (approximately 48 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline up to eos (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
Phase 1: Maximum Tolerated Dose (MTD)
Phase 1: Number of Participants With Adverse Events (AEs) by Occurrence, Nature, and Severity
Phase 1: Recommended Phase 2 Dose (RP2D)
+2 moreSecondary outcome measures
Phase 1: Anaemia Response in Participants as per International Working Group -Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) Criteria
Phase 1: Area Under the Concentration-time Curve (AUC) of Selinexor and Ruxolitinib
Phase 1: Duration of SVR25 Based on Local Assessment
+22 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
SENTRY Trial Design
5Treatment groups
Experimental Treatment
Active Control
Group I: Phase 3: Selinexor 60 mg + Ruxolitinib BIDExperimental Treatment2 Interventions
Participants with MF will receive a fixed starting dose of 60 mg selinexor (RD) oral tablets QW on Days 1, 8, 15, and 22 of each 28-day cycle in combination with a starting dose of 15 or 20 mg ruxolitinib BID based on the participants baseline platelet count.
Group II: Phase 1b: Selinexor and Ruxolitinib BIDExperimental Treatment2 Interventions
Participants with MF will receive a dose of 40 or 60 mg selinexor oral tablets QW on Days 1, 8, 15, and 22 of each 28-day cycle in combination with 15 or 20 mg ruxolitinib BID based on the participants baseline platelet count.
Group III: Phase 1a: Cohort 2: Selinexor 60 mg + Ruxolitinib BIDExperimental Treatment2 Interventions
Participants with MF will receive a dose of 60 mg selinexor oral tablets QW on Days 1, 8, 15, and 22 of each 28-day cycle in combination with 15 or 20 mg ruxolitinib BID based on the participants baseline platelet count.
Group IV: Phase 1a: Cohort 1: Selinexor 40 mg + Ruxolitinib BIDExperimental Treatment2 Interventions
Participants with MF will receive a dose of 40 milligrams (mg) selinexor oral tablets once weekly (QW) on Days 1, 8, 15, and 22 of each 28-day cycle in combination with 15 or 20 mg ruxolitinib twice a day (BID) based on the participants baseline platelet count.
Group V: Phase 3: Placebo + Ruxolitinib BIDActive Control2 Interventions
Participants with MF will receive a matching placebo of selinexor oral tablets QW on Days 1, 8, 15, and 22 of each 28-day cycle in combination with a starting dose of 15 or 20 mg ruxolitinib BID based on the participants baseline platelet count.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Selinexor
2020
Completed Phase 2
~1360
Ruxolitinib
2018
Completed Phase 3
~1140
Find a Location
Who is running the clinical trial?
Karyopharm Therapeutics IncLead Sponsor
87 Previous Clinical Trials
7,249 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of high blood pressure in the lungs.I have hepatitis B but have been on antiviral therapy for over 8 weeks and my viral load is under 100 IU/mL.I cannot tolerate two different anti-nausea medications for at least 2 treatment cycles.I have been treated with selinexor or similar drugs before.I will use effective birth control and not donate sperm during and for 90 days after treatment.I have been diagnosed with a specific type of bone marrow disorder according to the latest standards.My liver tests are within the normal range.I am not pregnant, will test before treatment, and will use birth control during and 90 days after treatment.My condition is classified as intermediate-1, intermediate-2, or high-risk according to DIPSS.I have HIV with a CD4+ count >= 350, no AIDS infections in the last year, and have been on ART for at least 4 weeks.I haven't needed strong IV drugs for an infection in the last week.I haven't had serious heart issues or strokes in the last 6 months.I haven't had any other cancers in the last 2 years, except for certain skin, breast, cervix, or prostate cancers.I have significant symptoms of myelofibrosis according to the MFSAF V4.0.I am not eligible for a stem cell transplant.My spleen is enlarged, measuring over 450 cm^3 on a recent scan.I am not allergic to selinexor, ruxolitinib, or their ingredients.I have had my spleen removed or received spleen radiation within the last 6 months.I had hepatitis C but have been treated and now have an undetectable viral load.I can provide bone marrow samples for the study.I have not taken strong CYP3A inhibitors or inducers within the last 7 or 14 days.I have not had major surgery in the last 4 weeks.I have been treated with JAK inhibitors for myelofibrosis.I am not pregnant or breastfeeding.I am able to get out of my bed or chair and move around.I am 18 years old or older.My white blood cell count is healthy without needing medication to boost it.I do not have severe GI issues that could affect medication absorption.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 3: Selinexor 60 mg + Ruxolitinib BID
- Group 2: Phase 3: Placebo + Ruxolitinib BID
- Group 3: Phase 1a: Cohort 1: Selinexor 40 mg + Ruxolitinib BID
- Group 4: Phase 1a: Cohort 2: Selinexor 60 mg + Ruxolitinib BID
- Group 5: Phase 1b: Selinexor and Ruxolitinib BID
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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 how many different medical settings is this research project being conducted today?
"A few of the 5 locations where this trial is being conducted are City of Hope in Duarte, California, The Oncology Institute of Hope & Innovation in Pasadena, Tennessee, and Vanderbilt Ingram Cancer Center in Nashville, Utah."
Answered by AI
What is the main reason people are prescribed Selinexor?
"Selinexor is often the last resort for patients who have not responded to other treatments like proteasome inhibitors and immunomodulatory agents. Selinexor has also shown promise in treating conditions such as polycythemia vera, polycythemia, and resistant or intolerant hydroxyurea cases."
Answered by AI
Are patients able to enroll in this trial at this time?
"That is correct. The clinicaltrials.gov website currently lists this study as open and recruiting patients. This trial was originally posted on March 11th, 2021 and was updated November 11th, 2022. There are a total of 237 participant slots available at 5 different locations."
Answered by AI
Are there other examples of Selinexor being used in a clinical setting?
"Selinexor was first evaluated in 2002 by the National Institutes of Health Clinical Center. As of now, 121 clinical trials have been completed while 147 are still recruiting patients. The majority of these active trials are based out of Duarte, California."
Answered by AI
How many study participants are currently enrolled?
"According to the study's sponsor, Karyopharm Therapeutics Inc, 237 patients are needed to complete this clinical trial. City of Hope in Duarte, California and The Oncology Institute of Hope & Innovation in Pasadena, Tennessee will be among the multiple sites hosting this research."
Answered by AI
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