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NCT Number: NCT05611931

Selinexor in Maintenance Therapy After Systemic Therapy for Participants With p53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma

The purpose of this study is to evaluate the efficacy and safety of selinexor as a maintenance treatment in patients with p53 wt endometrial carcinoma (EC), who have achieved a partial response (PR) or complete response (CR) (per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v 1.1]) after completing at least 12 weeks of platinum-based therapy. A total of 276 participants will be enrolled in the study and randomized in a 1:1 ratio to maintenance therapy with either selinexor or placebo.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Border Medical Oncology & Haematology, Albury, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients must meet all of the following inclusion criteria in order to be eligible to participate in this study:

  • Adults (Aged ≥ 18 years)
  • Histologically confirmed endometrial cancer (endometrioid, serous, undifferentiated, or carcinosarcoma sub-types) that is TP53 wild type by central NGSHistologically confirmed EC including endometrioid, serous, undifferentiated, and carcinosarcoma
  • Must have completed at least 12 weeks of platinum-based chemotherapy (with or without immune checkpoint inhibitors), with a confirmed partial or complete response according to RECIST v1.1
  • Must be able to initiate C1D1 within 3-8 weeks after last platinum dose
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate bone marrow function and organ function

Exclusion criteria

Patients meeting any of the following exclusion criteria are not eligible to participate in this study:

  • Uterine sarcomas, clear cell or small cell carcinoma with neuroendocrine differentiation
  • Palliative radiotherapy administered within 14 days of intended C1D1
  • Any gastrointestinal dysfunction that could interfere with the absorption of oral study therapy
  • Serious psychiatric or medical conditions that could interfere with study participation or would make study involvement unreasonably hazardous
  • Previous treatment with an XPO1 inhibitor
  • Stable disease or disease progression after platinum-based chemotherapy
  • Pregnancy, breastfeeding, or other legal/ethical restrictions to trial participation
  • Known dMMR/MSI-H EC tumors that are medically eligible to receive an immune checkpoint inhibitor

Treatment and study plan

Selinexor

Drug

Dose: 60 mg (3 tablets); Dosage form: film-coated, immediate-release tablet of 20 mg each; Route of administration: oral

Other names: KPT-330

Matching placebo for selinexor

Drug

Dose:60 mg (3 tablets); Dosage form: film-coated, immediate-release tablet of 20 mg each; Route of administration: oral

Primary outcomes

  1. Investigator assessed Progression Free Survival (PFS) per RECIST v1.1

    Time frame: From randomization until disease progression (PD) or death, whichever occurs first (up to 34 months)

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: Up to 34 months

    Time from randomization to death due to any cause

  2. Safety and tolerability of study drug (selinexor and placebo)

    Time frame: From start of study drug administration up to 34 months

    The safety and tolerability of study drug (selinexor and placebo) will be evaluated based on adverse event (AE) reports, physical examination results (including vital signs), and clinical laboratory results, by means of the occurrence, nature, and severity of AEs via Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0.

  3. Time to First Subsequent Therapy (TFST)

    Time frame: From randomization until date of initiation of first therapy after discontinuation of study drug or death, whichever occurs first (up to 34 months)

    Time from randomization until date of initiation of first therapy after discontinuation of study drug or death, whichever occurs first

  4. Time to Second Subsequent Therapy (TSST)

    Time frame: From randomization until date of initiation of second therapy after discontinuation of study drug or death, whichever occurs first (up to 34 months)

    Time from randomization until date of initiation of second therapy after discontinuation of study drug or death, whichever occurs first

  5. Progression-free survival after initiating a next-line treatment (PFS2)

    Time frame: From randomization until the next-line progression event or death due to any cause, up to 34 months

    Time from randomization until the progression event after initiating a next-line treatment or death due to any cause, whichever occurs first

  6. Progression-free Survival (PFS) as assessed by a Blinded Independent Central Review (BICR), per RECIST v1.1

    Time frame: From randomization until disease progression (PD) or death, whichever occurs first (up to 34 months)

  7. EuroQol-5 Dimensions-5 Levels Quality of Life Questionnaire (EQ-5D-5L)

    Time frame: From baseline and at specified timepoints up to 34 months

    EQ-5D-5L is a generic questionnaire that assesses health status as perceived by the patient across 5 categories (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and overall.

Sponsors and collaborators

Lead sponsor

Karyopharm Therapeutics Inc

Industry

Collaborators

  • Australia New Zealand Gynaecological Oncology Group
  • Belgian Gynaecological Oncology Group
  • Cancer Trials Ireland (CTI)
  • European Network of Gynaecological Oncological Trial Groups (ENGOT)
  • GOG Foundation
  • Grupo Español de Investigación en Cáncer de Ovario
  • Hellenic Cooperative Oncology Group
  • Israeli Society of Gynecologic Oncology
  • Mario Negri Gynecologic Oncology group (MaNGO)
  • Multicenter Italian Trials in Ovarian Cancer (MITO)
  • North Eastern German Society of Gynaecological Oncology
  • The Central and Eastern European Gynecologic Oncology Group

Registry information

Official study title

A Phase 3, Randomized, Placebo-Controlled, Double-Blind, Multicenter Trial of Selinexor in Maintenance Therapy After Systemic Therapy for Patients With p53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma

Acronym: XPORT-EC-042

Important dates

Study start
2023
Primary completion
2026
Study completion
2028
First posted
Nov 10, 2022
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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