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Selinexor

A Study of Selinexor in Combination With Standard of Care Therapy for Newly Diagnosed or Recurrent Glioblastoma

Ensayo de Karyopharm Therapeutics Inc. en Glioblastoma.

Más ensayos de: Glioblastoma.

Lo que ha anunciado la empresa

La empresa anunció que NO alcanzó su objetivo principal…Phase 3 XPORT-EC-042 trial (NCT05611931), evaluating selinexor as a maintenance-only therapy compared to placebo in adult patients with TP53 wild-type advanced or recurrent endometrial cancer. The trial did not meet its primary endpoint of progression-free survival. A trend favoring the selinexor arm was observed in the modified intent to treat (mITT) population (n=236), with a median PFS of 12.75 months in the selinexor arm compared…

En un 8-K del 13 ago 2026, en una frase que nombra «Selinexor». El documento en la SEC.

La empresa anunció que NO alcanzó su objetivo principal…results from its Phase 3 XPORT-EC-042 trial evaluating selinexor as a maintenance-only therapy compared to placebo in adult patients with TP53 wild-type advanced or recurrent endometrial cancer. The trial did not meet its primary endpoint of progression free survival (“PFS”). In the trial, patients were randomized 1:1 to receive either a 60 mg, once-weekly, administration of oral selinexor or placebo until disease progression. The trial…

En un 8-K del 31 jul 2026, en una frase que nombra «Selinexor». El documento en la SEC.

La empresa anunció que alcanzó su objetivo principal…results from the Phase 3 SENTRY trial, a randomized, double-blind trial evaluating 60 mg selinexor in combination with ruxolitinib in frontline myelofibrosis compared to ruxolitinib alone (n=353). The trial met the first co-primary endpoint of spleen volume reduction of 35% or more (SVR35) at week 24 and also demonstrated rapid, deep and sustained improvement in this endpoint over time. The trial did not meet its second co-primary endpoint…

En un 8-K del 14 may 2026, en una frase que nombra «Selinexor». El documento en la SEC.

Fase

Fase 1/2

Estado

Interrumpido

Participantes

74

previstos

Centros

18

Fin del objetivo primario

jul 2023

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en jun 2020.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Upon further consideration of the existing data and the competitive landscape, Karyopharm Therapeutics Inc has decided not to pursue the ongoing development of Selinexor in GBM at this time.».

Qué mide

Phase 1a and 1b: Maximum Tolerated Dose of Selinexor (At Cycle 1 (up to 42 days)) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is a Phase 1/2 study of selinexor in combination with standard of care (SoC) therapy for newly diagnosed glioblastoma (nGBM) or recurrent glioblastoma (rGBM). This study will be conducted in 2 phases: a Phase 1a dose finding study followed by Phase 1b (dose expansion) and a Phase 2 randomized efficacy exploration study and will independently evaluate 3 different combination regimens in 3 treatment arms in patients with nGBM (Arms A and B) or with rGBM (Arm C). * Arm A: evaluating the combination of selinexor with radiation therapy (S-RT) in nGBM participants with uMGMT * Arm B: evaluating the combination of selinexor with radiation therapy and temozolomide (TMZ) (S-TRT) in nGBM participants with methylated-O6-methylguanine-DNA-methyltransferase (mMGMT) * Arm C: evaluating the combination of selinexor with lomustine (or carmustine, if lomustine is not available) (S-L/C) in rGBM participants regardless of MGMT status * Arm D: evaluating the combination of selinexor with bevacizumab in rGBM participants regardless of MGMT status * Arm E: evaluating the combination of selinexor with tumor treating fields (TTField) in rGBM participants regardless of MGMT status

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Ficha completa en ClinicalTrials.gov (NCT04421378), actualizada en nov 2024.