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A Phase 3 Study of Relacorilant in Combination with Nab-Paclitaxel versus Nab-Paclitaxel Monotherapy in Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer

Clinical Trial Details

Sometimes tumors develop resistance to chemotherapy and the body stops responding to the drug and the cancer grows or spreads. The tumor may use cortisol, a steroid hormone naturally produced in the body, to develop chemotherapy resistance. Cortisol plays a role in controlling different processes throughout the body, including the body’s immune response (the reaction of the cells and fluids in the body to the presence of a foreign substance, such as a virus, an infection or cancer).

The primary purpose of this study is to determine if the combination of two drugs, relacorilant nab-paclitaxel, controls ovarian, primary peritoneal, or fallopian tube cancer better than nab-paclitaxel alone.

Relacorilant is a type of drug known as a glucocorticoid receptor (GR) modulator, which acts to block the action of cortisol in the body which may help prevent chemotherapy resistance. 

Nab-paclitaxel, also known as Abraxane, is a chemotherapy drug. Chemotherapy drugs are thought to interfere with the cell’s ability to divide and reproduce. Chemotherapy kills cells that divide rapidly, which includes most cancer cells. 

Relacorilant is considered experimental, which means it has not been approved by the United States Food and Drug Administration (FDA).
   
Nab-paclitaxel is currently only FDA approved to treat breast cancer, lung cancer, and pancreatic cancer and the use of nab-paclitaxel for the treatment of ovarian, primary peritoneal, or fallopian tube cancer is considered investigational.

Participants will be randomized into one of two treatment arms. There is an equal chance of being assigned to either arm. Arm A will receive nab-paclitaxel administered intravenously through a vein in combination with relacorilant taken orally. Arm B will receive nab-paclitaxel alone.

Study participation will vary depending on each participants outcomes, including how well they manage the treatment or they experience unmanageable side effects.

Key Eligibility: 
  1. Female patients over the age of 18 years old
  2. Confirmed diagnosis of high-grade (Grade 3) serous, epithelial ovarian, primary peritoneal, or fallopian tube carcinoma
  3. Patients must have platinum-resistant disease (6 months from completion of a platinum-containing therapy).
  4. Negative pregnancy test for patients of childbearing potential. Patients of childbearing potential must agree to use highly effective contraceptive method(s). 

 

Study contact by location

Upper East Side - Manhattan

Contact(s)

Francisco Ricci
212-746-9128
frr4004@med.cornell.edu

Brooklyn

Contact(s)

Kelsey Maguire Torres, RN
929-470-9507
kem4016@med.cornell.edu

Queens

Contact(s)

Charlotte Fong
718-660-1716
ccf4001@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

20222456

ClinicalTrials.gov:

NCT05257408

Sponsor:

CORT125134-556

Status

Open to Enrollment

Age Group

Adult

Sponsor