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Selinexor

A Study to Evaluate the Safety and Efficacy of Selinexor With or Without Pembrolizumab Versus Standard of Care in Previously Treated Metastatic Colorectal Cancer With RAS Mutations

Ensayo de Karyopharm Therapeutics Inc. en Cancer colorrectal metastasico.

Más ensayos de: Cáncer colorrectal metastásico.

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 2

Estado

Interrumpido

Participantes

13

previstos

Centros

3

Fin del objetivo primario

jun 2022

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en jun 2021.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Sponsor decision».

Qué mide

Arm B and C: Progression-free Survival (PFS) as Assessed by the Investigator Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (From the date of randomization until disease progression or death, whichever occurs first (up to 8 months)) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe purpose of this study is to evaluate the efficacy and safety of selinexor alone or with pembrolizumab in participants with advanced or metastatic colorectal cancer (CRC). Approximately 78 participants with advanced or metastatic CRC will be enrolled, and randomized (1:1:1) into three arms A (selinexor only), B (selinexor and pembrolizumab), and C (standard of care \[Combination of trifluridine and tipiracil\]). Randomization will be based on stratification factors: Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 versus 2. The end of treatment (EoT) visit will occur less than or equal to (\<=30) days post-treatment discontinuation. A survival follow-up visit will be performed every 3 months from EoT and will continue for 12 months.

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Ficha completa en ClinicalTrials.gov (NCT04854434), actualizada en oct 2023.