A Phase II Study of Relacorilant plus Nab-Paclitaxel in Women with Recurrent Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

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Full Title

A Phase 2, Randomized, Open-label, 3-arm Study of Relacorilant in Combination with Nab-Paclitaxel for Patients with Recurrent Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Purpose

The purpose of this study is to see if the combination of the drugs relacorilant and nab-paclitaxel is as effective as or more effective than nab-paclitaxel on its own for treating women with ovarian, fallopian tube, or primary peritoneal cancer that has come back and continued to grow after treatment with anticancer therapies. The study will also compare daily relacorilant plus nab-paclitaxel versus intermittent relacorilant in combination with nab-paclitaxel.

Relacorilant is an investigational drug that may prevent the resistance that cancer cells can develop to chemotherapy by blocking cortisol, a hormone tumors may use to resist the lethal effects of anticancer drugs. Patients in this study will be randomly assigned to receive daily relacorilant plus nab-paclitaxel, intermittent relacorilant plus nab-paclitaxel, or nab-paclitaxel alone. Patients receiving nab-paclitaxel alone who experience continued cancer growth may have the opportunity to cross over to the daily relacorilant group.

Nap-paclitaxel is given intravenously (by vein) and relacorilant 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 ovarian, fallopian tube, or primary peritoneal cancer that has come back or continued to grow despite platinum-based chemotherapy.
  • Patients should recover from the serious side effects of prior treatments before entering 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. Rachel Grisham at 646-888-4653.

Protocol

19-304

Phase

II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators