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Study of Relacorilant and Nab-Paclitaxel for Patients with Advanced, Platinum-Resistant Ovarian, Fallopian Tube, or Peritoneal Cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer known as advanced, platinum-resistant, high-grade epithelial ovarian, primary peritoneal, or fallopian-tube cancer. The study is testing a new treatment that combines two medications: relacorilant and nab-paclitaxel. Relacorilant is also known by its code name CORT125134. Nab-paclitaxel is a form of chemotherapy that is often used to treat various types of cancer. The purpose of this study is to compare the effectiveness of the combination of relacorilant and nab-paclitaxel against nab-paclitaxel alone in treating this type of cancer.

Participants in the study will receive either the combination of relacorilant and nab-paclitaxel or nab-paclitaxel by itself. The treatment will be given over a period of 28 days, and the study will monitor how the cancer responds to the treatment. The study aims to see if the combination treatment can help control the cancer better than nab-paclitaxel alone. The study will also look at how long patients live without the cancer getting worse and other measures of how well the treatment works.

This trial is important for understanding if adding relacorilant to nab-paclitaxel can provide a new option for patients with this challenging type of cancer. The study will help determine if the combination treatment can improve outcomes for patients compared to the standard treatment with nab-paclitaxel alone. Participants will be closely monitored throughout the study to ensure their safety and to gather important information about the treatment's effects.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will be randomly assigned to one of two groups: one receiving a combination of relacorilant and nab-paclitaxel, and the other receiving nab-paclitaxel alone.

    The patient will be required to provide informed consent and may need to provide a tumor tissue sample if available.

  2. Step 2

    Treatment phase

    Patients in the combination group will take relacorilant orally in the form of soft capsules. The specific dosage and frequency will be determined by the study protocol.

    All patients will receive nab-paclitaxel intravenously. This medication is administered as a dispersion for infusion, with the dosage and schedule specified by the study protocol.

  3. Step 3

    Monitoring and assessments

    Throughout the study, patients will undergo regular assessments to monitor their health and the effectiveness of the treatment.

    These assessments may include imaging tests to measure disease progression, blood tests, and other evaluations as required by the study protocol.

  4. Step 4

    End of treatment

    The treatment phase will continue until the patient experiences disease progression, unacceptable side effects, or chooses to withdraw from the study.

    The study is expected to conclude by December 31, 2025, but individual participation may end earlier based on the patient's condition and response to treatment.

  5. Step 5

    Follow-up

    After completing the treatment phase, patients will enter a follow-up period where their health will continue to be monitored.

    The follow-up will help gather additional data on the long-term effects and outcomes of the treatment.

Who can join the trial?

14 criteria

  • You must sign and date a form that shows you agree to participate in the study.
  • You need to agree to provide a sample of your tumor tissue, if available. If not, you may agree to a new biopsy.
  • You should have a life expectancy of at least 3 months.
  • You must have at least one tumor that can be measured, according to specific guidelines. Tumors that were treated with radiation before cannot be used unless they have grown again.
  • Your overall health should be good, as measured by a specific scale called the Eastern Cooperative Oncology Group (ECOG) performance status, which should be 0 or 1.
  • You should be able to follow the study's requirements.
  • You must be able to swallow pills and should not have uncontrolled vomiting.
  • You should have received at least 1 but no more than 3 previous treatments for cancer. You must have tried at least one treatment with a drug containing platinum and a drug called bevacizumab.
  • Your organs should be working well, according to specific lab tests.
  • If you can have children, you must have a negative pregnancy test and agree to use effective birth control methods. Hormonal birth control is not allowed.
  • You can receive COVID-19 vaccines if recommended by the study doctor, unless it interferes with the study.
  • You must be a female aged 18 years or older.
  • You need to have a confirmed diagnosis of a specific type of cancer, which includes high-grade ovarian, primary peritoneal, or fallopian tube cancer.
  • Your cancer must be resistant to platinum treatment, meaning it worsened less than 6 months after finishing a platinum-based therapy.

Who cannot join the trial?

4 criteria

  • Patients who have a different type of cancer than the one being studied cannot participate.
  • Patients who are not female cannot participate.
  • Patients who are under the age of 18 or over the age of 65 cannot participate.
  • Patients who are part of a vulnerable population, meaning they might need special protection or care, cannot participate.
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Investigated drugs

  • Relacorilant

    is a medication being studied for its potential to enhance the effectiveness of cancer treatment. In this trial, it is used in combination with another drug to see if it can help improve outcomes for patients with certain types of advanced cancer.

  • Nab-Paclitaxel

    is a chemotherapy drug used to treat various types of cancer. It works by stopping the growth of cancer cells. In this study, it is used both alone and in combination with relacorilant to compare the effectiveness of the treatments.

What is already known about the treatment

  • Relacorilant

    Relacorilant is administered orally and is currently being studied in clinical trials for its potential use in treating advanced, platinum-resistant, high-grade epithelial ovarian, primary peritoneal, or fallopian-tube cancer. It is not yet widely used in standard medical practice, as it is still under investigation. The medication works by blocking the effects of cortisol, a stress hormone, which may help in reducing cancer cell growth. Relacorilant is classified as a glucocorticoid receptor antagonist.

  • Nab-Paclitaxel

    Nab-Paclitaxel is administered intravenously and is an established treatment for various types of cancer, including breast cancer and pancreatic cancer. In the context of the clinical trial, it is being evaluated for its effectiveness in combination with relacorilant for treating advanced, platinum-resistant ovarian and related cancers. Nab-Paclitaxel works by inhibiting cell division, which helps to stop the growth of cancer cells. It is classified as a taxane, a type of chemotherapy drug.

Investigated diseases

  • Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian Cancer

    This is a type of ovarian cancer that has become resistant to platinum-based chemotherapy, which is a common treatment for ovarian cancer. It is characterized by the presence of high-grade cancer cells that originate from the epithelial cells lining the ovaries. The disease often progresses rapidly and can spread to other parts of the body, including the abdomen and pelvis. Symptoms may include abdominal pain, bloating, and changes in bowel habits. The cancer is considered advanced when it has spread beyond the ovaries to other areas.

  • Primary Peritoneal Cancer

    This cancer originates in the peritoneum, a thin layer of tissue lining the abdomen and covering the uterus, bladder, and rectum. It is similar to epithelial ovarian cancer in terms of symptoms, progression, and treatment. The disease can cause abdominal swelling, pain, and digestive issues as it progresses. It often spreads within the abdominal cavity and can affect nearby organs. The cancer is considered advanced when it has spread beyond the peritoneum.

  • Fallopian-Tube Cancer

    This rare cancer starts in the fallopian tubes, which connect the ovaries to the uterus. It shares many characteristics with ovarian cancer, including symptoms like pelvic pain and abnormal vaginal bleeding. The disease can progress by spreading to nearby organs and tissues within the pelvis and abdomen. It is often diagnosed at an advanced stage due to its subtle symptoms. The cancer is considered advanced when it has spread beyond the fallopian tubes.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514080-25-00Protocol codeCORT125134-556Estimated enrolment381 patientsSponsorCorcept Therapeutics Inc.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).