A Phase I Study of Selinexor (KPT-330) with Paclitaxel and Carboplatin for Treating Advanced Ovarian and Endometrial Cancers

Full Title

A Phase 1 Open-label Study of the Selective Inhibitor of Nuclear Export, Selinexor (KPT-330) in Combination with Paclitaxel and Carboplatin in Patients with Advanced Ovarian or Endometrial Cancers

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.

Carboplatin and paclitaxel are chemotherapy drugs commonly used to treat advanced or recurrent ovarian, fallopian tube, primary peritoneal, and endometrial cancers. In this study, researchers want to find the highest dose of selinexor that can be given safely with carboplatin and each of two different doses of paclitaxel in patients with advanced ovarian, fallopian tube, primary peritoneal, and endometrial cancers. Selinexor is taken orally (by mouth), and carboplatin and paclitaxel are given intravenously (by vein).

Eligibility

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

  • Patients must have ovarian, fallopian tube, or primary peritoneal cancer or ovarian carcinosarcoma that has come back despite no more than one prior regimen of chemotherapy that included a platinum drug, OR patients must have advanced endometrial cancer or endometrial carcinosarcoma that has either not been treated yet or was treated with one prior regimen of platinum-based chemotherapy.
  • Patients must have recovered from the serious side effects of previous treatments before entering the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are 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 patients 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

14-110

Phase

I

Investigator

Co-Investigators

Locations