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Back|NCT05611931Recruiting
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

Phase
Phase 3
Sponsor
Karyopharm Therapeutics Inc
Enrollment
276
Timeline
Apr 2023 → Jan 2028
About This Study

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.

Eligibility Criteria

Inclusion Criteria

  • 1Adults (Aged ≥ 18 years)
  • 2Histologically 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
  • 3Must 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
  • 4Must be able to initiate C1D1 within 3-8 weeks after last platinum dose
  • 5Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • 6Adequate bone marrow function and organ function

Exclusion Criteria

  • 1Uterine sarcomas, clear cell or small cell carcinoma with neuroendocrine differentiation
  • 2Palliative radiotherapy administered within 14 days of intended C1D1
  • 3Any gastrointestinal dysfunction that could interfere with the absorption of oral study therapy
  • 4Serious psychiatric or medical conditions that could interfere with study participation or would make study involvement unreasonably hazardous
  • 5Previous treatment with an XPO1 inhibitor
  • 6Stable disease or disease progression after platinum-based chemotherapy
  • 7Pregnancy, breastfeeding, or other legal/ethical restrictions to trial participation
  • 8Known dMMR/MSI-H EC tumors that are medically eligible to receive an immune checkpoint inhibitor

Locations

220 sites participating in this study

Emory University

Atlanta, Georgia 30322

Recruiting

Susan Modesitt

The University of Alabama at Birmingham

Birmingham, Alabama 35205

Recruiting

Michael Toboni

Honor Health

Phoenix, Arizona 85016

Recruiting

Lyndsay Willmott

Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →