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NCT05611931 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Endometrial Cancer, sponsored by Karyopharm Therapeutics.

Recruiting
Registry status
Phase 3
Development phase
276
Enrollment target
20
Study locations

NCT05611931 is a Phase 3 study of Endometrial Cancer that is actively recruiting participants, run by Karyopharm Therapeutics. The registered enrollment target is 276 participants, below the 523-participant average among 181 other Endometrial Cancer trials with a reported enrollment target (47% lower). The trial reports 20 study locations across 7 states.

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The verdict

NCT05611931, a Phase 3 study of Endometrial Cancer, is actively recruiting participants, sponsored by Karyopharm Therapeutics.

RECRUITING
Registry status
Phase 3
Development phase
276 participants
Enrollment target
20
Study locations

Study Summary

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.

Conditions Studied

Interventions

  • DRUG Selinexor
  • DRUG Matching Placebo for selinexor

Study Locations (20)

California

  • UC DAVIS - Davis
  • City of Hope National Medical Center - Duarte
  • Chao Family Comprehensive Cancer Center and Ambulatory Care - Irvine
  • City of Hope at Irvine Lennar - Irvine
  • Cancer and Blood Specialty Clinic - Los Alamitos
  • UCLA - Women's Health Clinical Research Unit - Los Angeles
  • Long Beach Memorial Medical Center - Los Angeles
  • UC Irvine - Orange
  • Stanford University - Palo Alto
  • California Pacific Medical Center - San Francisco

Florida

  • Broward Health Medical Center - Fort Lauderdale
  • Mount Sinai Comprehensive Cancer Center - Miami Beach
  • Advent Health - Orlando

Colorado

  • Highlands Ranch Hospital - Highlands Ranch
  • University of Colorado Cancer Center - Highlands Ranch

Georgia

  • Grady Hospital - Atlanta
  • Emory University - Atlanta

Alabama

  • The University of Alabama at Birmingham - Birmingham

Arizona

  • Honor Health - Phoenix

Arkansas

  • University of Arkansas for Medical Sciences - Little Rock

Trial Details

FieldValue
Enrollment Target 276 participants
Start Date 2023-04-18
Est. Completion 2028-01
Phase Phase 3

Sponsor

Karyopharm Therapeutics

25 total trials

What the Registry Record Tells You About NCT05611931

The ClinicalTrials.gov registry entry for NCT05611931 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 276 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 523-participant average among 181 other Endometrial Cancer trials with a reported enrollment target (47% lower). The listed sponsor is Karyopharm Therapeutics, which has 25 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Endometrial Cancer appearing as the primary indexed condition, and to 2 interventions - of which Selinexor is the first listed.

NCT05611931 reports 20 study locations spanning 7 distinct geographic areas - top geographies include California, Florida, Colorado.

Frequently Asked Questions

What is clinical trial NCT05611931 about?

NCT05611931 is a clinical study titled "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....

What is the current status of trial NCT05611931?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 276 participants. The study started on 2023-04-18. Estimated completion is 2028-01.

What conditions does trial NCT05611931 study?

This clinical trial studies the following conditions: Endometrial Cancer.

What interventions are being tested in trial NCT05611931?

The interventions under investigation include: Selinexor (DRUG), Matching Placebo for selinexor (DRUG).

Who is sponsoring clinical trial NCT05611931?

This trial is sponsored by Karyopharm Therapeutics, which has 25 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05611931 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.