Study on Maintenance Treatment with Selinexor or Placebo After Chemotherapy in Endometrial Cancer Patients

Sponsor: Karyopharm Therapeutics Inc

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03555422

Provider View

This clinical trial is testing whether the drug selinexor, given after chemotherapy, can help control advanced or returning endometrial cancer. Participants who have responded to initial chemotherapy will receive either selinexor or a placebo to see if it helps maintain their cancer remission.

Patient Parameters

Program Overview

This study is designed to find out if the drug selinexor can help keep endometrial cancer from progressing after initial chemotherapy. Participants with advanced or returning endometrial cancer who have shown a positive response to at least 12 weeks of taxane-platinum chemotherapy will be randomly assigned to receive either selinexor or a placebo. The study aims to determine if selinexor can effectively maintain cancer remission.

Eligibility Criteria

Inclusion Criteria

  • Women aged 18 or older.
  • Diagnosed with endometrial cancer of specific types, including endometrioid, serous, undifferentiated, or carcinosarcoma.
  • Completed at least 12 weeks of taxane-platinum chemotherapy and achieved partial or complete remission.
  • Must start the study drug 5 to 8 weeks after finishing chemotherapy.
  • Good overall health with a performance status score of 0 or 1.
  • Adequate blood cell counts and organ function based on specific lab tests.
  • Life expectancy of at least 12 weeks and fit for experimental therapy.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for one week after the last dose.
  • Must provide written informed consent before participating.

Exclusion Criteria

  • Have certain types of cancer, such as sarcomas or clear cell carcinomas.
  • Received a blood or platelet transfusion within 4 weeks before starting the study.
  • Currently receiving other cancer treatments.
  • Previously treated with specific cancer drugs like XPO1 inhibitors or PD-1/PD-L1 immunotherapy.
  • Participating in another clinical trial or receiving investigational drugs.
  • Recent major surgery or injuries.
  • Have other serious medical conditions or infections.
  • Pregnant or breastfeeding women.
  • Unable to swallow tablets or have digestive issues affecting drug absorption.
  • Have psychiatric or substance use issues affecting study participation.
  • Unable or unwilling to follow study procedures.

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