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

Study acronym: XPORT-EC-042
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites reduced: 199 → 191 locations Primary completion date changed from estimate of Aug 2026 to May 22, 2026 · Eligibility criteria expanded, about 14 words · Secondary endpoints: details revised at 1 of 7 entries · 1 more Show 4 more changesShow less
    • Primary completion date changed from estimate of Aug 2026 to May 22, 2026
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: details revised at 1 of 7 entries
    • Publications: details revised at 3 of 3 entries
  2. Trial sites reduced: 204 → 199 locations Eligibility criteria shortened, about 8 wordsv28 Show 1 more changeShow less
    • Eligibility criteria shortened, about 8 words

    See this version in full on ClinicalTrials.gov ↗

  3. Trial status changed: Recruiting → Active, Not Recruiting Trial sites reduced: 217 → 204 locations · Enrollment target: estimated 276 to confirmed 257v27 Show 2 more changesShow less
    • Trial sites reduced: 217 → 204 locations
    • Enrollment target: estimated 276 to confirmed 257
  4. Site details revised at 1 of 217 sitesv26
  5. Study sites: 220 to 217v25
Show 23 earlier versionsHide 23 earlier versions
  1. Site details revised at 27 of 220 sitesv24
  2. Secondary endpoints revised (7)v23 See this version in full on ClinicalTrials.gov ↗
  3. Primary completion date: Jan 31, 2025 to Aug 2026 Primary endpoint revised · Enrollment target: 220 to 276 · Study sites: 207 to 220 · 4 morev22 Show 7 more changesShow less
    • Primary endpoint revised
    • Enrollment target: 220 to 276
    • Study sites: 207 to 220
    • Completion date: Jan 31, 2028 to Jan 2028
    • Eligibility criteria shortened, about 909 words
    • Secondary endpoints: 9 to 7
    • Collaborators: 9 to 12

    See this version in full on ClinicalTrials.gov ↗

  4. Study sites: 166 to 207 Eligibility criteria revisedv21 Show 1 more changeShow less
    • Eligibility criteria revised

    See this version in full on ClinicalTrials.gov ↗

  5. Study sites: 163 to 166v20
  6. Study sites revised (163)v19 See this version in full on ClinicalTrials.gov ↗
  7. Study sites: 125 to 163v18
  8. Study sites: 120 to 125v17
  9. Study sites: 102 to 120v16
  10. Study sites: 99 to 102v15
  11. Study sites: 76 to 99v14
  12. Study sites: 72 to 76v13
  13. Study sites: 63 to 72 Collaborators: 8 to 9v12 Show 1 more changeShow less
    • Collaborators: 8 to 9

    See this version in full on ClinicalTrials.gov ↗

  14. Study sites: 51 to 63v11
  15. Study sites: 47 to 51v10
  16. Primary completion date: Jun 30, 2024 to Jan 31, 2025 Start date: Nov 1, 2022 to Apr 18, 2023 · Study sites: 37 to 47 · Completion date: Aug 31, 2025 to Jan 31, 2028v9 Show 3 more changesShow less
    • Start date: Nov 1, 2022 to Apr 18, 2023
    • Study sites: 37 to 47
    • Completion date: Aug 31, 2025 to Jan 31, 2028
  17. Study sites: 26 to 37v8
  18. Re-verified, no change to tracked fieldsv7
  19. Study sites: 12 to 26v6
  20. Study sites: 7 to 12v5
  21. Study sites: 3 to 7v4
  22. Study sites: 2 to 3v3
  23. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 2v2 Show 1 more changeShow less
    • Study sites: 0 to 2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05611931
Lead Sponsor Karyopharm Therapeutics Inc
Collaborators: GOG Foundation, European Network of Gynaecological Oncological Trial Groups (ENGOT), Belgian Gynaecological Oncology Group, North Eastern German Society of Gynaecological Oncology, The Central and Eastern European Gynecologic Oncology Group, Israeli Society of Gynecologic Oncology, Australia New Zealand Gynaecological Oncology Group, Multicenter Italian Trials in Ovarian Cancer (MITO), Grupo Español de Investigación en Cáncer de Ovario, Hellenic Cooperative Oncology Group, Cancer Trials Ireland (CTI), Mario Negri Gynecologic Oncology group (MaNGO)
Conditions Endometrial Cancer
Enrollment 257 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov