This trial is no longer recruiting

Recruitment for this study has ended, so applications are closed. You can still read the trial details, or browse similar trials that are currently recruiting.

Not recruiting
Phase 3

Selinexor

Sponsor:

Karyopharm Therapeutics Inc

Code:

NCT05611931

Conditions

Endometrial Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Selinexor

Matching Placebo for selinexor

Study Details

Brief 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

Endometrial Cancer

Study ID

NCT05611931

Start date

Apr 18, 2023

Status verified date

May, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

257 participants

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Selinexor

Participants will receive a fixed dose of selinexor 60 milligrams (mg) oral tablets once weekly (QW) on Days 1, 8, 15, and 22 of each 28-day cycle.

placebo comparator: Placebo

Participants will receive matching placebo for selinexor oral tablets QW on Days 1, 8, 15, and 22 of each 28-day cycle.

Interventions

Selinexor

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

Matching Placebo for selinexor

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

Primary outcome measure

  • 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) ]

Central Contacts and Locations

More Information

Sponsor

Karyopharm Therapeutics Inc

Last update posted

May 29, 2026

Last verified

May, 2026

Keywords

  • 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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-25. This information was provided to ClinicalTrials.gov by Karyopharm Therapeutics Inc on 2026-05-29. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.