A Phase III Study of Maintenance Therapy with Selinexor or Placebo after Combination Chemotherapy for Patients with Advanced or Recurrent Endometrial Cancer

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Full Title

A Randomized, Double-Blind, Phase 3 Trial of Maintenance with Selinexor/Placebo after Combination Chemotherapy for Patients with Advanced or Recurrent Endometrial Cancer (WIRB)

Purpose

Tumor suppressor proteins work inside normal cells to prevent the uncontrolled cell growth that can lead to cancer. Some cancer cells thrive by getting rid of tumor suppressor proteins. Selinexor (also known as KPT-330) is an investigational drug that works by trapping tumor suppressor proteins inside cancer cells, causing them to die or stop growing.

In this study, researchers are evaluating the safety and effectiveness of maintenance therapy with selinexor in women with advanced or recurrent endometrial cancer who have received combination chemotherapy. Patients will be randomly assigned to receive selinexor or a placebo (inactive drug). Selinexor is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have advanced or recurrent endometrial cancer or carcinosarcoma of the uterus and received at least 12 weeks of taxane-platinum chemotherapy.
  • At least 3 weeks must pass between the completion of prior therapy and entry into the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for women age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Vicky Makker at 646-888-4224.

Protocol

19-314

Phase

III

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators