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Study of Relacorilant, Nab-Paclitaxel, and Bevacizumab for Patients with Advanced Ovarian, Peritoneal, or Fallopian Tube 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 advanced forms of cancer, specifically epithelial ovarian cancer, primary peritoneal cancer, and fallopian-tube cancer. The study will explore the effects of a treatment combination that includes the medication relacorilant, also known by its code name CORT125134, along with nab-paclitaxel and bevacizumab. Relacorilant is taken orally in the form of a soft capsule, while nab-paclitaxel and bevacizumab are administered through intravenous infusion, which means they are given directly into a vein.

The purpose of this study is to evaluate how effective this combination of medications is in treating the specified types of cancer. Participants in the study will receive these medications and will be monitored over time to assess their response to the treatment. The study will track the progression of the disease and any changes in the participants' health. The trial aims to gather information on how well the treatment works and any side effects that may occur.

Throughout the study, participants will undergo regular check-ups and assessments to monitor their health and the impact of the treatment. The study is designed to provide valuable insights into the potential benefits and risks of using relacorilant in combination with nab-paclitaxel and bevacizumab for treating these advanced cancers. This research could contribute to developing more effective treatment options for patients with these types of cancer in the future.

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

    Beginning of treatment

    Upon joining the study, you will begin treatment with a combination of medications. These include relacorilant, bevacizumab, and paclitaxel albumin-bound. Each medication has a specific way it is administered and a schedule you will need to follow.

  2. Step 2

    Medication administration

    Relacorilant is taken orally in the form of a soft capsule. You will be instructed on the exact dosage and frequency by the medical team.

    Bevacizumab is given through an intravenous infusion, which means it is administered directly into your vein. The medical team will provide details on how often you will receive this medication.

    Paclitaxel albumin-bound is also administered via intravenous infusion. The frequency and dosage will be explained by the medical team.

  3. Step 3

    Monitoring and assessments

    Throughout the trial, your health and response to the treatment will be closely monitored. This includes regular assessments to measure the effectiveness of the treatment and to check for any side effects.

    The primary goal is to evaluate the progression-free survival (PFS), which is the time from the start of the treatment until the disease progresses or you experience any cause of death.

  4. Step 4

    Follow-up and evaluations

    You will have follow-up visits to assess the overall response rate (ORR), duration of response (DoR), and clinical benefit rate (CBR) at 24 weeks. These evaluations help determine how well the treatment is working.

    Safety assessments will also be conducted to monitor any adverse events (AEs) or serious adverse events (SAEs) that may occur during the trial.

  5. Step 5

    Completion of trial

    The trial is expected to continue until 2027. Upon completion, you will have a final assessment to evaluate the overall outcomes of the treatment.

    The results will contribute to understanding the effectiveness and safety of the treatment combination for advanced ovarian, primary peritoneal, or fallopian-tube cancer.

Who can join the trial?

18 criteria

  • Must have a confirmed diagnosis of high-grade serous or endometrioid, epithelial ovarian, primary peritoneal, or fallopian-tube cancer. Tumors with a mix of high-grade serous and endometrioid are allowed, but not if they include other types.
  • Must have a negative pregnancy test if capable of becoming pregnant.
  • If capable of becoming pregnant, must agree to use highly effective birth control methods. Hormonal contraceptives (like birth control pills) are not allowed.
  • Must have platinum-resistant disease, meaning the cancer progressed in less than 183 days after the last dose of a platinum-based therapy. Patients whose cancer did not respond to initial platinum-based therapy or progressed within 30 days of the last dose in the initial treatment are not eligible.
  • Must have a life expectancy of at least 3 months, as judged by the study doctor.
  • Must have at least one tumor that can be measured by specific medical criteria. Tumors that were previously treated with radiation are not considered measurable unless they have shown growth.
  • Must have an ECOG performance status of 0 or 1, which means being fully active or restricted in physically strenuous activity but able to carry out light work.
  • Must be able to follow the study requirements.
  • Must be able to swallow and keep down oral medication and not have uncontrolled vomiting.
  • Must have received at least one but no more than three previous treatments for ovarian cancer, with documented disease progression or intolerance to the most recent treatment. At least one of these treatments must have been platinum-based. Maintenance therapy is considered part of the most recent treatment and not a separate one. Changes in chemotherapy due to side effects still count as one treatment. Pre-surgery and post-surgery treatments count as one treatment. Hormonal therapies are not counted separately. Patients are eligible regardless of previous treatment with bevacizumab. Patients with a known BRCA1/2 mutation should have been treated with a PARP inhibitor unless deemed unsuitable, declined, or unavailable.
  • Must have adequate organ function based on specific laboratory tests, including:
    • Absolute neutrophil count (a type of white blood cell) of at least 1500 cells/mm3 without support from growth factors within 2 weeks before the screening test.
    • Platelet count of at least 100,000/mm3 without transfusion within 2 weeks before the screening test.
    • Hemoglobin level of at least 9 g/dL without transfusion within 2 weeks before the screening test.
    • AST or ALT (liver enzymes) levels no more than 2.5 times the upper limit of normal, or no more than 5 times if there are liver metastases.
    • Total bilirubin no more than 1.5 times the upper limit of normal (patients with Gilbert’s syndrome are eligible if total bilirubin is no more than 3 times the upper limit).
    • Albumin level of at least 2.5 g/dL.
    • Creatinine clearance (a measure of kidney function) of at least 35 mL/min.
    • Proteinuria (protein in urine) less than 2+ by dipstick test. If 2+ or more, a 24-hour urine collection must show less than 1 gram of protein in 24 hours.

Who cannot join the trial?

4 criteria

  • Patients who do not have advanced, epithelial ovarian, primary peritoneal, or fallopian-tube cancer cannot participate.
  • Only female patients can participate; male patients are excluded.
  • Patients who are not in the specified age range cannot participate. (The specific age range is not provided here.)
  • Patients who are part of a vulnerable population may be excluded. This typically refers to groups who may have difficulty giving informed consent or are at higher risk of harm.
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Investigated drugs

  • Relacorilant

    is a medication being studied for its potential to help treat certain types of cancer. In this trial, it is being tested to see if it can improve the effectiveness of other cancer treatments. Relacorilant works by blocking the effects of a hormone called cortisol, which can sometimes help cancer cells grow. By blocking cortisol, relacorilant may help slow down or stop the growth of cancer cells.

  • Nab-Paclitaxel

    is a type of chemotherapy drug used to treat cancer. It works by stopping cancer cells from dividing and growing, which can help shrink tumors and slow the spread of cancer. Nab-paclitaxel is a form of paclitaxel that is combined with a protein called albumin, which helps the drug get into the cancer cells more effectively.

  • Bevacizumab

    is a medication that helps stop the growth of new blood vessels that tumors need to grow. By blocking these blood vessels, bevacizumab can help slow down the growth of the tumor and may even shrink it. This medication is often used in combination with other cancer treatments to improve their effectiveness.

What is already known about the treatment

  • Relacorilant

    Relacorilant is administered orally and is currently being studied in combination with other drugs for its potential benefits in treating advanced ovarian, primary peritoneal, or fallopian-tube cancer. It is not yet widely used in standard medical practice, as it is still under investigation in clinical trials. The main therapeutic indication for relacorilant is to help improve outcomes in patients with these types of cancer. At the molecular level, relacorilant works by blocking the effects of cortisol, a stress hormone, which may help reduce cancer cell growth. It is classified as a glucocorticoid receptor antagonist.

  • Nab-Paclitaxel

    Nab-Paclitaxel is administered intravenously and is a well-established medication used in the treatment of various cancers, including breast and lung cancer. In the context of the clinical trial, it is being tested in combination with other drugs for advanced ovarian, primary peritoneal, or fallopian-tube cancer. Its main therapeutic indication is to inhibit cancer cell growth by interfering with cell division. Nab-Paclitaxel works by stabilizing microtubules, which are structures that help cells divide, thus preventing cancer cells from multiplying. It is classified as a taxane chemotherapy agent.

  • Bevacizumab

    Bevacizumab is administered through an intravenous infusion and is a widely used medication in cancer treatment, particularly for colorectal, lung, and kidney cancers. In the clinical trial, it is being evaluated in combination with other drugs for advanced ovarian, primary peritoneal, or fallopian-tube cancer. The main therapeutic indication for bevacizumab is to inhibit the growth of new blood vessels that supply tumors, effectively starving the cancer cells. It works by blocking a protein called vascular endothelial growth factor (VEGF), which is essential for blood vessel formation. Bevacizumab is classified as an angiogenesis inhibitor.

Investigated diseases

  • Advanced Epithelial Ovarian Cancer

    This disease originates in the epithelial cells on the surface of the ovary. It is characterized by the uncontrolled growth of abnormal cells that can invade nearby tissues. As the disease progresses, it may spread to other parts of the body, including the abdomen and pelvis. Symptoms often include abdominal bloating, pelvic pain, and changes in bowel habits. The disease is typically diagnosed at an advanced stage due to its subtle early symptoms. It is a type of cancer that primarily affects women.

  • Primary Peritoneal Cancer

    This cancer develops in the peritoneum, a thin layer of tissue lining the abdomen. It shares similarities with epithelial ovarian cancer in terms of symptoms and progression. The disease often presents with abdominal swelling, pain, and digestive disturbances. As it advances, it can spread to other abdominal organs. The condition is more common in women and can occur even if the ovaries have been removed. It is often detected at a later stage due to non-specific symptoms.

  • Fallopian Tube Cancer

    This rare cancer begins in the fallopian tubes, which connect the ovaries to the uterus. It typically involves the uncontrolled growth of cells in the lining of the fallopian tubes. Symptoms may include pelvic pain, abnormal vaginal discharge, and a pelvic mass. The disease can spread to nearby organs and tissues as it progresses. It is often diagnosed in later stages due to vague symptoms. This type of cancer primarily affects women.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517432-21-00Protocol codeCORT125134-557Estimated enrolment182 patientsSponsorCorcept Therapeutics Inc.

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