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Selective Inhibitor of Nuclear Export (SINE)

Selinexor for Solid Tumors

Phase 2

Recruiting

Led By Michael Ortiz, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Karnofsky ≥ 60% for patients > 16 years of age and Lansky ≥ 60 for patients ≤ 16 years of age.

Renal Function: GFR ≥ 50 ml/min/1.73 m2 determined via any of these methods: Nuclear radioisotope, 24 hr urine creatinine clearance, Serum cystatin c, Serum creatinine using the Schwartz formula for estimating creatinine clearance (Schwartz et al. J Peds, 106:522, 1985).

Must not have

Has received selinexor or another XPO1 inhibitor previously.

Males or females of reproductive potential may not participate unless they have agreed to use two effective methods of birth control, including a medically accepted barrier or contraceptive method (e.g., male or female condom) for the duration of the study. Abstinence is an acceptable method of birth control.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if a drug can treat Wilms tumor, rhabdoid tumor, MPNST and other tumors with high XPO1 activity or genetic changes.

Who is the study for?

This trial is for people under 51 with certain relapsed/refractory solid tumors, including Wilms tumor and rhabdoid tumor. Participants must be over 6 months old, have recovered from previous cancer treatments, and meet specific health criteria related to organ function. Pregnant or breastfeeding women can't join, nor can those who've had prior treatment with XPO1 inhibitors.

What is being tested?

The study tests Selinexor's effectiveness on patients with solid tumors that produce excess XPO1 or have genetic changes increasing XPO1 activity. It includes different age groups (cohorts) to assess the drug's pharmacokinetics (how it moves through the body) before moving onto phase II where its efficacy is measured.

What are the potential side effects?

While not explicitly listed in the provided information, common side effects of Selinexor may include nausea, fatigue, loss of appetite, weight loss, low blood counts leading to increased risk of infections or bleeding problems.

Eligibility Criteria

Inclusion Criteria

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

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I am mostly able to care for myself and carry on normal activities.

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My kidney function is good, with a GFR of 50 or higher.

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My blood cell counts meet the required levels without recent medical help.

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I am 6 years old or older.

Exclusion Criteria

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

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

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I agree to use two forms of birth control or practice abstinence during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Overall Response Rate

Side effects data

From 2022 Phase 3 trial • 402 Patients • NCT03110562

50%

Thrombocytopenia

45%

Anaemia

39%

Nausea

29%

Decreased appetite

29%

Diarrhoea

27%

Weight decreased

24%

Neuropathy peripheral

24%

Vomiting

23%

Fatigue

21%

Neutropenia

21%

Cataract

15%

Asthenia

12%

Upper respiratory tract infection

11%

Pyrexia

11%

Constipation

Oedema peripheral

Pneumonia

Lymphopenia

Dizziness

Insomnia

Dehydration

Back pain

Leukopenia

Bronchitis

Cough

Acute kidney injury

Abdominal pain

Muscular weakness

Lower respiratory tract infection

Pain in extremity

Sepsis

Hyperglycaemia

Urinary tract infection

Nasopharyngitis

Hyponatraemia

Toothache

Disturbance in attention

Cardiac failure

Hypertension

Blood uric acid increased

Embolism

Haemoglobin decreased

Cardiac failure acute

Pulmonary contusion

Peripheral swelling

Blood creatinine increased

Paraesthesia

Infection

Respiratory syncytial virus infection

Dyspepsia

Syncope

Clostridium difficile infection

Compression fracture

Multiple fractures

Myocardial infarction

C-reactive protein increased

Cerebral haemorrhage

Ischaemic stroke

Sudden death

Oropharyngeal pain

Cognitive disorder

Confusional state

Influenza

Septic shock

Osteonecrosis of jaw

Taste disorder

Hyperkalaemia

Depression

Cerebrovascular accident

Bronchitis viral

100%

80%

60%

40%

20%

Study treatment Arm

SVdX Arm: Selinexor + Bortezomib + Dexamethasone

SdX Arm: Selinexor + 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

4Treatment groups

Experimental Treatment

Group I: Cohort D.1 Other Solid TumorExperimental Treatment1 Intervention

Participants must not qualify for Cohorts A, B, or C but have a solid tumor (no hematologic malignancies including lymphoma) for which there is specific evidence that this particular patient's tumor may benefit from selinexor.

Group II: Cohort C.1 MPNSTExperimental Treatment1 Intervention

Participants will have progressive, relapsed, unresectable or metastatic MPNST

Group III: Cohort B.1 Rhabdoid TumorExperimental Treatment1 Intervention

Participants will have any Rhabdoid tumor

Group IV: Cohort A.1 Wilms TumorExperimental Treatment1 Intervention

Participants will have any type of Wilms tumor or nephroblastoma

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Selinexor

2020