Study on Selinexor as Maintenance Therapy for Advanced or Recurrent Endometrial Cancer with P53 Wild-Type

Sponsor: Karyopharm Therapeutics Inc

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05611931

This clinical trial is testing the effectiveness and safety of the drug selinexor as a maintenance treatment for patients with advanced or recurrent endometrial cancer who have responded well to initial chemotherapy. The study involves 220 participants who will receive either selinexor or a placebo after completing at least 12 weeks of platinum-based chemotherapy.

Patient Parameters

Program Overview

The aim of this study is to evaluate how well selinexor works as a maintenance treatment for patients with advanced or recurrent endometrial cancer that is P53 wild-type. Participants who have shown a partial or complete response to at least 12 weeks of platinum-based chemotherapy will be randomly assigned to receive either selinexor or a placebo. The study will include 220 participants to assess the drug's effectiveness and safety.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of endometrial cancer, including specific types like endometrioid, serous, undifferentiated, and carcinosarcoma.
  • Have P53 wild-type status confirmed by specific genetic testing.
  • Completed at least 12 weeks of platinum-based chemotherapy and achieved a partial or complete response.
  • Have not received adjuvant or neoadjuvant therapy for Stage I-III disease.
  • Have a good performance status, meaning they are fully active or have some restrictions but can still perform light work.
  • Have adequate bone marrow and organ function based on recent lab tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for 90 days after the last dose.
  • Must be able to start the study drug 3 to 8 weeks after finishing chemotherapy.
  • Must sign an informed consent form agreeing to participate in the study.

Exclusion Criteria

  • Have certain types of uterine cancer, like clear cell or small cell carcinoma with neuroendocrine differentiation.
  • Have received a blood or platelet transfusion within 2 weeks before starting the study.
  • Are on high-dose steroid therapy.
  • Have not recovered from major surgery within 28 days before starting the study.
  • Have significant side effects from previous cancer treatments that have not improved.
  • Have had recent palliative radiotherapy for pain control.
  • Have gastrointestinal issues that could affect the absorption of the study drug.
  • Cannot tolerate anti-nausea medications.
  • Have an active infection requiring treatment within 1 week of screening.
  • Have a serious psychiatric or medical condition that could interfere with the study.
  • Have previously been treated with an XPO1 inhibitor.
  • Have stable disease or progression on the post-chemotherapy scan.
  • Have received any other cancer treatment within 3 weeks before starting the study.
  • Have had major injuries or surgery within 14 days before starting the study.
  • Have another cancer that has not been disease-free for at least 3 years, except for certain non-threatening cancers.
  • Have a history of allergic reactions to similar drugs.
  • Have active brain metastases that are not adequately treated.
  • Are pregnant or breastfeeding.
  • Have any other serious illness or condition that could affect participation in the study.

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