Selinexor for Endometrial Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Endometrial Cancer+1 More
Selinexor - Drug
Eligibility
18+
Female
What conditions do you have?
Select

Study Summary

This trial is testing if selinexor can help treat endometrial cancer that has progressed or come back after initial treatment.

Eligible Conditions
  • Endometrial Cancer

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 12 Secondary · Reporting Duration: Every 12 weeks during study period, at PD and post PD at 3 and 6 months (approximately 12 months after the last participant enrolled)

Month 12
Health-Related Quality of Life (HR-QoL): Measured by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30
Health-Related Quality of Life: Measured by EORTC QLQ-EN24
Health-Related Quality of Life: Measured by EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)
Month 12
Number of Participants with Significant Physical Examination, Clinical Laboratory, and Vital Signs Results
Number of Participants with Treatment Emergent Adverse Events (TEAEs), Occurrence, Nature, and Severity of AEs
Month 12
Progression Free Survival: Assessed by Blinded Independent Central Review (BICR), per RECIST v1.1
Month 12
Overall Survival (OS)
Month 12
Disease Specific Survival (DSS)
Month 12
Progression Free Survival (PFS)
Month 12
Time to First Subsequent Treatment (TFST)
Month 12
Progression-free Survival After Subsequent Treatment (PFS2)
Month 12
Time to Second Subsequent Treatment (TSST)
Week 16
Disease Control Rate (DCR)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Part 1: Cohort A-Ovarian Carcinoma: Selinexor up to 60 mg/m^2 BIW
88%Nausea
72%Vomiting
52%Anaemia
48%Weight Decreased
48%Fatigue
48%Decreased Appetite
48%Thrombocytopenia
28%Vision Blurred
28%Dizziness
28%Abdominal Pain
28%Dysgeusia
28%Constipation
28%Asthenia
28%Insomnia
24%Diarrhoea
24%Hypokalaemia
24%Dyspnoea
16%Hyponatraemia
16%Urinary Tract Infection
12%Anxiety
12%Oedema Peripheral
12%Hypomagnesaemia
12%Abdominal Distension
12%Stomatitis
12%Malaise
12%Pyrexia
12%Pulmonary Embolism
12%Headache
12%Cough
8%Hyperglycaemia
8%Ascites
8%Cystitis
8%Laryngitis
8%Visual Impairment
8%Muscular Weakness
8%Pleural Effusion
8%Ileus
8%Dehydration
8%Hydronephrosis
8%Device Occlusion
8%Face Oedema
8%Somnolence
8%Back Pain
8%Agitation
8%Hypotension
8%Oedema
8%Neutropenia
8%Lung Infection
4%Pneumonia
4%Device Related Infection
4%Hypertension
4%Vertigo
4%Pneumothorax
4%Embolism
4%Depression
4%Haematuria
4%Alopecia
4%Arthralgia
4%Vaginal Haemorrhage
4%Dry Mouth
4%Dysuria
4%Contusion
4%Hallucination
4%Confusional State
4%Peripheral Sensory Neuropathy
4%Muscle Spasms
4%Acute Kidney Injury
This histogram enumerates side effects from a completed 2017 Phase 2 trial (NCT02025985) in the Part 1: Cohort A-Ovarian Carcinoma: Selinexor up to 60 mg/m^2 BIW ARM group. Side effects include: Nausea with 88%, Vomiting with 72%, Anaemia with 52%, Weight Decreased with 48%, Fatigue with 48%.

Trial Design

2 Treatment Groups

Selinexor
1 of 2
Matching placebo for selinexor
1 of 2

Experimental Treatment

Non-Treatment Group

248 Total Participants · 2 Treatment Groups

Primary Treatment: Selinexor · Has Placebo Group · Phase 3

Selinexor
Drug
Experimental Group · 1 Intervention: Selinexor · Intervention Types: Drug
Matching placebo for selinexor
Drug
PlaceboComparator Group · 1 Intervention: Matching placebo for 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: every 12 weeks during study period, at pd and post pd at 3 and 6 months (approximately 12 months after the last participant enrolled)

Who is running the clinical trial?

Israel Society of Gynecologic OncologyUNKNOWN
1 Previous Clinical Trials
220 Total Patients Enrolled
1 Trials studying Endometrial Cancer
220 Patients Enrolled for Endometrial Cancer
The GOG Foundation, Inc.UNKNOWN
1 Previous Clinical Trials
220 Total Patients Enrolled
1 Trials studying Endometrial Cancer
220 Patients Enrolled for Endometrial Cancer
North-Eastern German Society of Gynaecologic OncologyUNKNOWN
1 Previous Clinical Trials
220 Total Patients Enrolled
1 Trials studying Endometrial Cancer
220 Patients Enrolled for Endometrial Cancer
The Central and Eastern European Gynecologic Oncology GroupOTHER
3 Previous Clinical Trials
824 Total Patients Enrolled
1 Trials studying Endometrial Cancer
220 Patients Enrolled for Endometrial Cancer
Belgium and Luxembourg Gynaecological Oncology GroupUNKNOWN
1 Previous Clinical Trials
220 Total Patients Enrolled
1 Trials studying Endometrial Cancer
220 Patients Enrolled for Endometrial Cancer
Karyopharm Therapeutics IncLead Sponsor
84 Previous Clinical Trials
7,895 Total Patients Enrolled
1 Trials studying Endometrial Cancer
220 Patients Enrolled for Endometrial Cancer
Spanish Research Group in Ovarian CancerUNKNOWN
1 Previous Clinical Trials
220 Total Patients Enrolled
1 Trials studying Endometrial Cancer
220 Patients Enrolled for Endometrial Cancer
Multicentre Italian Trials in Ovarian Cancer and Gynecologic MalignanciesUNKNOWN
1 Previous Clinical Trials
220 Total Patients Enrolled
1 Trials studying Endometrial Cancer
220 Patients Enrolled for Endometrial Cancer
Michael Kauffman, MD, PhDStudy DirectorKaryopharm Therapeutics Inc
9 Previous Clinical Trials
1,204 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Female Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have endometrial cancer of the endometrioid, serous, or undifferentiated type.
You have a performance status of 0-1.
You are female and at least 18 years of age at the time of informed consent.
You have an absolute neutrophil count (ANC) greater than or equal to (≥) 1.5*10^9/L; platelet count ≥100*10^9 per liter (/L); hemoglobin ≥9.
You have a creatinine clearance of ≥20 mL/min.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 16th, 2021

Last Reviewed: November 22nd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.