Actively Recruiting

Phase 2
Age: 12Months +
All Genders
NCT05985161

A Study of Selinexor in People With Wilms Tumors and Other Solid Tumors

Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-05-06

45

Participants Needed

16

Research Sites

313 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this study is to find out whether selinexor is an effective treatment for people who have a relapsed/refractory Wilms tumor, rhabdoid tumor, MPNST, BCOR-driven sarcoma, or another solid tumor that makes a higher than normal amount of XPO1 or has genetic changes that increase the activity of XP01.

CONDITIONS

Official Title

A Study of Selinexor in People With Wilms Tumors and Other Solid Tumors

Who Can Participate

Age: 12Months +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 6 years or older at the time of informed consent
  • Age 2 years to under 6 years at the time of informed consent if PK cohort 1 is open; otherwise may enroll in phase 2
  • Age 12 months to under 2 years at the time of informed consent if PK cohort 2 is open; otherwise may enroll in phase 2
  • Signed informed consent by patient and/or parent or legally authorized representative; assent when appropriate
  • Karnofsky score 60% or higher for patients older than 16 years; Lansky score 60 or higher for patients 16 years or younger
  • Diagnosis of Wilms tumor or nephroblastoma in second or greater relapse, or refractory or first relapse with high risk histology, or refractory or first relapse after specific chemotherapy regimens
  • Diagnosis of rhabdoid tumor including related subtypes, with failure to respond to at least one prior systemic therapy
  • Diagnosis of progressive, relapsed, unresectable or metastatic MPNST with failure to respond to at least one prior systemic therapy
  • Diagnosis of solid tumor (excluding hematologic malignancies) with evidence for selinexor benefit and failure to respond to at least one prior systemic therapy, with principal investigator approval
  • Diagnosis of solid tumor with activating genomic alteration involving BCOR with principal investigator approval
  • Measurable disease for phase II patients; evaluable or measurable disease for PK cohorts
  • Adequate liver function within 14 days prior to treatment start
  • Adequate kidney function within 14 days prior to treatment start
  • Adequate blood counts within 14 days prior to treatment start
  • Recovery from acute toxic effects of prior anti-cancer therapy and meeting specified washout periods
Not Eligible

You will not qualify if you...

  • Prior treatment with selinexor or another XPO1 inhibitor
  • Uncontrolled infection; controlled infection within 1 week prior to treatment start is allowed
  • Prior solid organ transplant
  • Active treatment for graft-versus-host disease after allogeneic bone marrow transplant
  • Medical, psychiatric, or social conditions that impair ability to comply with study requirements
  • Pregnancy or breast-feeding
  • Males or females of reproductive potential not agreeing to use two effective forms of birth control during the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 16 locations

1

Children's Hospital of Los Angeles (Data Collection Only)

Los Angeles, California, United States, 90027

Actively Recruiting

2

Stanford Medicine Children's Health (Data Collection Only)

Palo Alto, California, United States, 94304

Actively Recruiting

3

Children's National Hospital (Data Collection Only)

Washington D.C., District of Columbia, United States, 20010

Actively Recruiting

4

Children's Healthcare of Atlanta (Data Collection and Specimen Analysis)

Atlanta, Georgia, United States, 30322

Actively Recruiting

5

Ann & Robert H. Lurie Children'S Hospital of Chicag

Chicago, Illinois, United States, 60611

Actively Recruiting

6

Dana Farber Cancer Institute (Data Collection Only)

Boston, Massachusetts, United States, 02115

Actively Recruiting

7

Washington University

St Louis, Missouri, United States, 63110

Actively Recruiting

8

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States, 07920

Actively Recruiting

9

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States, 07748

Actively Recruiting

10

Memorial Sloan Kettering Bergen (Limited protocol activities)

Montvale, New Jersey, United States, 07645

Actively Recruiting

11

Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities )

Commack, New York, United States, 11725

Actively Recruiting

12

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States, 10604

Actively Recruiting

13

Memorial Sloan Kettering Cancer Center (All protocol activites)

New York, New York, United States, 10065

Actively Recruiting

14

Memorial Sloan Kettering Nassau (Limited protocol activities)

Rockville Centre, New York, United States, 11553

Actively Recruiting

15

Cincinnati Children's Hospital Medical Center (Data collection only)

Cincinnati, Ohio, United States, 45229

Actively Recruiting

16

Cook Children's Health Care System (Data Collection Only)

Fort Worth, Texas, United States, 76104

Actively Recruiting

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Research Team

M

Michael Ortiz, MD

CONTACT

J

Julia Glade Bender, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

5

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A Study of Selinexor in People With Wilms Tumors and Other Solid Tumors | DecenTrialz