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Selinexor Maintenance Therapy for Endometrial Cancer (ENGOT-EN5 Trial)

Phase 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

Completed a single line of at least 12 weeks of taxane-platinum combination therapy and achieved partial remission (PR) or complete remission (CR) according to RECIST version 1.1 for specific disease stages

Must be able to initiate study drug 5 to 8 weeks after completion of their final dose of chemotherapy

Must not have

Previous treatment with an exportin 1 (XPO1) inhibitor

Major injuries or surgery within 14 days prior to C1D1 and/or planned surgery during the on-treatment study period

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 12 weeks during study period, at pd and post pd at 3 and 6 months (approximately 12 months after the last participant enrolled)

Awards & highlights

Pivotal Trial

Summary

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

Who is the study for?

This trial is for women aged 18+ with advanced or recurrent endometrial cancer who've responded to taxane-platinum chemotherapy. They must have good performance status, adequate organ function, and not be pregnant or breastfeeding. Exclusions include previous treatment with certain inhibitors or immunotherapies, recent transfusions, major surgeries, other active cancers (except some skin cancers), uncontrolled infections, and inability to swallow tablets.

What is being tested?

The SIENDO trial tests if selinexor works as a maintenance therapy after initial successful chemotherapy in patients with endometrial cancer. Participants are randomly assigned in a 2:1 ratio to receive either selinexor (80 mg weekly) or a placebo until their disease progresses.

What are the potential side effects?

Selinexor may cause side effects like nausea, vomiting, fatigue, loss of appetite, weight loss, diarrhea or constipation. It can also affect blood counts leading to anemia and increase the risk of infections due to low white blood cell counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I completed a specific cancer treatment and my cancer partially or completely responded.

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I can start the study drug 5-8 weeks after my last chemotherapy dose.

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I am fully active or can carry out light work.

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I am a woman and at least 18 years old.

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My cancer is a specific type of endometrial cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with an XPO1 inhibitor before.

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I haven't had major surgery or injuries in the last 14 days and don't plan any during the study.

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I have no known allergies or adverse reactions to selinexor.

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My heart condition is unstable.

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I am not pregnant or breastfeeding.

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I haven't needed IV drugs for an infection in the last week.

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I cannot swallow pills or have a condition that affects how my body absorbs medication.

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I have active cancer spread to my brain.

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I am currently receiving treatment for cancer.

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My cancer is a type of sarcoma, small cell, or clear cell carcinoma.

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I have been treated with PD-1 or PD-L1 immunotherapy before.

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I haven't had cancer treatment or radiation in the last 3 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 12 weeks during study period, at pd and post pd at 3 and 6 months (approximately 12 months after the last participant enrolled)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 12 weeks during study period, at pd and post pd at 3 and 6 months (approximately 12 months after the last participant enrolled)

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 12 weeks during study period, at pd and post pd at 3 and 6 months (approximately 12 months after the last participant enrolled) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression Free Survival (PFS)

Secondary study objectives

Disease Control Rate (DCR)

Disease Specific Survival (DSS)

Health-Related Quality of Life (HR-QoL): Measured by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30

+7 more

Side effects data

From 2022 Phase 3 trial • 402 Patients • NCT03110562

43%

Weight decreased

29%

Cough

29%

Thrombocytopenia

29%

Decreased appetite

29%

Nausea

21%

Fatigue

21%

Anaemia

21%

Constipation

21%

Diarrhoea

14%

Neuropathy peripheral

14%

Oedema peripheral

14%

Pneumonia

14%

Paraesthesia

14%

Cataract

14%

Vomiting

14%

Headache

Urinary tract infection

Asthma

Disturbance in attention

Respiratory syncytial virus infection

Neutropenia

Peripheral swelling

Mental status changes

Lower respiratory tract infection

Hyperthyroidism

Back pain

Pain in extremity

Basal cell carcinoma

Hyponatraemia

Skin lesion

Oropharyngeal pain

Pyrexia

Cardiac failure

Hepatitis

Pharyngitis

Hypophagia

Pollakiuria

Bronchiectasis

Non-cardiac chest pain

C-reactive protein increased

Taste disorder

Haemorrhagic transformation stroke

Abdominal pain

Insomnia

Dyspepsia

Haemoglobin decreased

Infection

Hyperglycaemia

Toothache

Ecchymosis

Upper respiratory tract infection

Nasopharyngitis

Fungal skin infection

Viral infection

Hypertension

Muscular weakness

100%

80%

60%

40%

20%

Study treatment Arm

SdX Arm: Selinexor + Dexamethasone

SVdX Arm: Selinexor + Bortezomib + Dexamethasone

SVd Arm: Selinexor + Bortezomib + Dexamethasone

Vd Arm: Bortezomib + Dexamethasone

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: SelinexorExperimental Treatment1 Intervention

Participants will receive fixed dose of selinexor 80 mg (or 60 mg for participants with a body mass index \[BMI\] less than \[\<\] 20 kilogram per meter square \[kg/m\^2\]) oral tablets QW on Days 1, 8, 15, and 22 of each 28-day cycle.

Group II: Matching placebo for selinexorPlacebo Group1 Intervention

Participants will receive matching placebo for selinexor oral tablets QW on Days 1, 8, 15, and 22 of each 28-day cycle.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Selinexor

2020

Completed Phase 3

~1730

0 / 17Eligibility criteria met