A Study of Extended-Release Onapristone in Gynecologic Cancers that Respond to Progesterone

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Full Title

Basket Study of the Oral Progesterone Antagonist Onapristone ER (Apristor) in Women with Progesterone Receptor Positive (PR+) Recurrent Granulosa Cell Tumor, Low Grade Serous Ovarian Cancer or Endometrioid Endometrial Cancer

Purpose

Progesterone is a hormone that is responsible for regulating the menstrual cycle in women. In women with progesterone receptor-positive cancers, the cancer cells take control of progesterone and use it to grow and spread. Onapristone extended-release (ER) is an investigational drug that stops progesterone from attaching to cancer cells. It is considered a hormonal therapy.

Since granulosa cell ovarian cancer, low-grade serous ovarian cancer, and endometrioid endometrial cancer use progesterone to grow, onapristone ER may shrink the cancer or stop it from growing and spreading. In this study, researchers are assessing onapristone ER in women with progesterone receptor-positive ovarian cancer, low-grade serous ovarian cancer, and endometrioid endometrial cancer. Onapristone ER 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 progesterone receptor-positive granulosa cell ovarian cancer, low-grade serous ovarian cancer, or endometrioid endometrial cancer that has already been treated with one prior regimen of chemotherapy. The first group of patients to be enrolled will be those with low-grade serous ovarian cancer.
  • At least 3 weeks must pass since the completion of prior chemotherapy and 4 weeks since prior surgery, radiation therapy, or hormonal therapy and entry into the study.
  • This study is for women age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Rachel Grisham at 646-888-4653.

Protocol

19-061

Phase

II

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators