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Clinical trialNCT05952687WithdrawnPhase 1Interventional

Trial of Idasanutlin and Selinexor Therapy for Children With Progressive/Relapsed AT/RT or Extra-CNS Malignant Rhabdoid Tumors

SponsorSt. Jude Children's Research HospitalEnrollment0Atypical Teratoid/Rhabdoid TumorAtypical Teratoid/Rhabdoid Tumor of CNSCNS TumorRhabdoid Tumor
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

iSTAR is an open-label, multi-center, phase 1b study of oral XPO1 inhibitor selinexor and oral MDM2 inhibitor idasanutlin in children with progressive or recurrent atypical teratoid/rhabdoid tumors (AT/RT), malignant rhabdoid tumors (MRT) and synchronous/metachronous rhabdoid tumors. Primary Objectives * To determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of combination treatment with oral idasanutlin and selinexor in children with recurrent or progressive AT/RT or MRT. * To characterize the plasma pharmacokinetics of oral idasanutlin and selinexor in children with recurrent or progressive AT/RT or MRT, to assess potential covariates to explain the inter- and intra-individual pharmacokinetic variability. Secondary Objectives * Evaluate safety of the combination treatment with oral idasanutlin and selinexor in children * Evaluate efficacy of the combination treatment of idasanutlin and selinexor as measured by objective response (partial response \[PR\] or complete response \[CR\]) rate separately in progressive/relapsed AT/RT and progressive/relapsed MRT * Estimate progression-free and overall-survival separately in progressive/relapsed AT/RT and progressive/relapsed MRT

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

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Sites

No facility list is in our current data snapshot for this study. The registry record on ClinicalTrials.gov ↗ carries any published locations. Why? →

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

IdasanutlinSelinexor →
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 Mar 2024
Primary completion
30 Sept 2025
Completion
31 Aug 2032
Last update posted
27 Mar 2024
Registered enrollment
0
Registry id
NCT05952687

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.