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Selective Inhibitor of Nuclear Export (SINE)

Phase 2 Double-blinded: Selinexor for Liposarcoma (SEAL Trial)

Phase 2 & 3
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomization in the phase 3 open label period until the documentation of cr or pr (up to 70 months)
Awards & highlights

SEAL Trial Summary

This study is evaluating whether a drug called selinexor can improve the survival of people with a type of cancer called liposarcoma.

Eligible Conditions
  • Liposarcoma

SEAL Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomization in the phase 3 open label period until the documentation of cr or pr (up to 70 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomization in the phase 3 open label period until the documentation of cr or pr (up to 70 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 2 Double Blind: Progression-free Survival (PFS) as Per RECIST Version 1.1
Phase 2 Open Label: Progression-free Survival (PFS) as Per RECIST Version 1.1
Phase 3 Double Blind: Progression-free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
+1 more
Secondary outcome measures
Phase 2 Double Blind: Number of Participants With TEAEs and Serious TEAEs
Phase 2 Double Blind: Overall Response Rate (ORR)
Phase 2 Double Blind: Overall Survival (OS)
+19 more

Side effects data

From 2017 Phase 2 trial • 116 Patients • NCT02025985
78%
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

SEAL Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Phase 3 Double-blinded: SelinexorExperimental Treatment1 Intervention
Participants received a fixed blinding dose of 60 mg selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle until PD.
Group II: Phase 2 Double-blinded: SelinexorExperimental Treatment1 Intervention
Participants received a fixed blinding dose of 60 milligrams (mg) selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle until progressive disease (PD).
Group III: Phase 2 Double-blinded: Placebo Followed by Open Label- SelinexorPlacebo Group1 Intervention
Participants received a fixed blinding dose of placebo matched to selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle until PD in double-blinded treatment period. Participants in the placebo group who had PD during the Phase 2 double-blinded treatment, will be elected to cross over to open-label selinexor.
Group IV: Phase 3 Double-blinded: Placebo Followed by Open Label- SelinexorPlacebo Group1 Intervention
Participants received a fixed blinding dose of placebo matched to selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle until PD or development of unacceptable toxicity. Participants in the placebo group who had PD during the Phase 3 double-blinded treatment, will be elected to cross over to open-label 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?

Karyopharm Therapeutics IncLead Sponsor
87 Previous Clinical Trials
7,237 Total Patients Enrolled
1 Trials studying Liposarcoma
Michael Kauffman, MD, Ph.DStudy DirectorKaryopharm Therapeutics Inc
4 Previous Clinical Trials
832 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Selinexor in Advanced Liposarcoma
2016. "Selinexor in Advanced Liposarcoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02606461.
~37 spots leftby Apr 2025
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