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

a study on Endometrial Cancer

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis UC Irvine UCLA
Dates
study started
study ends around
Principal Investigator
by Carolyn Haunschild (ucla)

Description

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.

Official 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

Keywords

Endometrial Cancer, Selinexor, KPT-330, Advanced or Recurrent Endometrial Carcinoma, XPORT-EC, ENGOT-EN20, GOG-3083, XPORT-EC-042, p53 wild-type, Tumor protein 53 wild-type, Endometrial Neoplasms

Eligibility

You can join if…

Open to people ages 18 years and up

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

You CAN'T join if...

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

Locations

  • UC DAVIS not yet accepting patients
    Davis 5341704 California 5332921 95616 United States
  • UCLA - Women's Health Clinical Research Unit accepting new patients
    Los Angeles 5368361 California 5332921 90095 United States
  • UC Irvine withdrawn
    Orange 5379513 California 5332921 92868 United States
  • Chao Family Comprehensive Cancer Center and Ambulatory Care withdrawn
    Irvine 5359777 California 5332921 92612 United States
  • California Pacific Medical Center accepting new patients
    San Francisco 5391959 California 5332921 94109 United States
  • City of Hope at Irvine Lennar accepting new patients
    Irvine 5359777 California 5332921 92618 United States
  • Cancer and Blood Specialty Clinic not yet accepting patients
    Los Alamitos 5368304 California 5332921 90720 United States
  • Long Beach Memorial Medical Center accepting new patients
    Los Angeles 5368361 California 5332921 90806 United States
  • Stanford University accepting new patients
    Palo Alto 5380748 California 5332921 94304 United States
  • City of Hope National Medical Center accepting new patients
    Duarte 5344147 California 5332921 91010 United States

Lead Scientist at University of California Health

  • Carolyn Haunschild (ucla)
    HS Assistant Clinical Professor, Obstetrics and Gynecology, Medicine. Authored (or co-authored) 8 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Karyopharm Therapeutics Inc
ID
NCT05611931
Phase
Phase 3 Endometrial Cancer Research Study
Study Type
Interventional
Participants
Expecting 276 study participants
Last Updated