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Selective Inhibitor of Nuclear Export (SINE)

Selinexor for Sarcoma

Phase 1

Waitlist Available

Led By Albiruni Razak, M.D.

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

Patients must have histologically confirmed locally advanced/unresectable or metastatic STS

Must not have

Major surgery within 4 weeks before initiation of therapy

Has received selinexor or another XPO1 inhibitor previously

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of first dose of selinexor until the date of first documented progression, assessed up to 12 months.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug, selinexor, for people with soft tissue sarcomas who have run out of other treatment options. Selinexor works by trapping proteins that would normally cause cancer cells to die, causing the cancer cells to die or stop growing.

Who is the study for?

This trial is for adults over 18 with advanced soft tissue sarcomas that can't be treated with standard therapies. Participants must have certain blood counts, organ functions within specific ranges, and not be pregnant or breastfeeding. They should also agree to use contraception and not have had recent cancer treatments or major surgeries.

What is being tested?

The study tests different low doses and schedules of Selinexor taken orally to see if they're effective but cause fewer side effects in sarcoma patients. Arm A will test the drug four days a week on specific sarcoma types, while Arm B involves any soft tissue sarcoma subtype taking it once weekly.

What are the potential side effects?

While the trial aims to reduce side effects by adjusting dosages, potential side effects may include nausea, vomiting, loss of appetite (anorexia), changes in liver function tests, fatigue, blood count issues which could lead to increased risk of infections or bleeding.

Eligibility Criteria

Inclusion Criteria

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

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I am fully active or have some restrictions but can still care for myself.

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My sarcoma is advanced, cannot be surgically removed, or has spread.

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My liver is functioning well according to recent tests.

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I am using two birth control methods or, if male, using a barrier method if my partner can have children.

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My kidneys are working well, with a creatinine clearance of 20 mL/min or more.

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My cancer type is either MPNST, ESS, or LMS.

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I am older than 18 years.

Exclusion Criteria

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

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I have not had major surgery in the last 4 weeks.

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I have previously been treated with selinexor or a similar drug.

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I am unable or unwilling to take recommended medications for nausea or appetite loss.

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I do not have stomach or bowel problems that could affect medication absorption.

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I do not have any current infections or haven't had one in the last week.

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I am currently receiving other approved or experimental cancer treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of first dose of selinexor until the date of first documented progression, assessed up to 12 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of first dose of selinexor until the date of first documented progression, assessed up to 12 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of first dose of selinexor until the date of first documented progression, assessed up to 12 months. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of toxicity and safety of Selinexor given on either a metronomic (Arm A) or split dosing (Arm B) schedule: Adverse Events

Recommended phase 2 dose of Selinexor given metronomically

Secondary study objectives

Area under the plasma concentration versus time curve (AUC) of metronomic Selinexor

Characterization of the toxicity of metronomic Selinexor

Clinical Benefit Rate (CBR) of metronomic Selinexor

+4 more

Side effects data

From 2022 Phase 3 trial • 402 Patients • NCT03110562

43%

Weight decreased

29%

Cough

29%

Thrombocytopenia

29%

Nausea

29%

Decreased appetite

21%

Anaemia

21%

Fatigue

21%

Constipation

21%

Diarrhoea

14%

Oedema peripheral

14%

Pneumonia

14%

Neuropathy peripheral

14%

Paraesthesia

14%

Cataract

14%

Vomiting

14%

Headache

Fungal skin infection

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

Hyponatraemia

Skin lesion

Oropharyngeal pain

Pyrexia

Cardiac failure

Hepatitis

Pharyngitis

Pollakiuria

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

Viral infection

Hypertension

Muscular weakness

Bronchiectasis

Hypophagia

Basal cell carcinoma

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

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Split dosingExperimental Treatment1 Intervention

The second arm of the study is an open-label, non randomized, phase 1b study of selinexor in patients with any histological subtype of STS administered orally one day per week, 40mg in the morning, 20mg in the afternoon and 20mg at night as part of a 28 day cycle. Twenty patients will be accrued to this arm.

Group II: Metronomic dosingExperimental Treatment1 Intervention

This Arm is an open-label, non-randomized, phase 1 study of metronomic dosing of selinexor in patients with locally advanced or metastatic MPNST, ESS, LMS. Up to seven dose levels of Selinexor will be investigated. Patients will undergo 3+3 based dose escalation to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of Selinexor. Escalating doses of selinexor will be given starting with 2.5 mg (taken orally 4 days in a row followed by 3 days break from treatment, repeating this weekly as part of a 28-day cycle). The first dose for the first 2 patients at each dose level will be staggered by 7 days. Minimum number of patients treated in this trial arm is 18 patients, and maximum 36 patients. Schedule: Selinexor flat dosing with dose levels (DLs) of 2.5mg (DL1), 5mg (DL2), 7.5mg (DL3), 10mg (DL4), 12.5mg (DL5), 15mg (DL6), 17.5mg (DL7). A DL-1 (1.25 mg) is also incorporated.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Selinexor

2020

Completed Phase 3

~1730

0 / 13Eligibility criteria met