Testing relacorilant and nab-paclitaxel for various types of cancer

Recruting new patients

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    What is this study about?

    The study is being conducted to investigate a new treatment for advanced ovarian, peritoneal, or fallopian tube cancer that has been unresponsive to standard treatment. The focus is on assessing whether a specific combination of drugs (Relacorilant and Nab-Paclitaxel) is more effective than using Nab-Paclitaxel alone. The primary objective is to determine if this combination can prolong the period before cancer progression without causing excessive side effects, in comparison to the use of Nab-Paclitaxel alone. Another goal is to evaluate whether the treatment can lead to a reduction in the size of the cancer and prevent further progression for an extended duration. Patients will undergo regular assessments to monitor disease progression and survival. Criteria such as RECIST, a measurement system, and a blood test checking for the presence of CA-125, a substance elevated in cancer patients, will be employed to assess disease progress.

    Learn more about this Trial

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      Locations

      Where does the clinical trial take place?

      Aalst , Belgium

      Brussels , Belgium

      Charleroi , Belgium

      Hasselt , Belgium

      Leuven , Belgium

      Liu00e8ge , Belgium

      Lille , France

      Montpellier , France

      Nancy , France

      Nice , France

      Paris , France

      Plu00e9rin , France

      Budapest , Hungary

      Debrecen , Hungary

      Gyu0151r , Hungary

      Catania , Italy

      Legnago , Italy

      Milano , Italy

      Pavia , Italy

      Roma , Italy

      Rome , Italy

      Torino , Italy

      Treviso , Italy

      Gdynia , Poland

      Poznau0144 , Poland

      Siedlce , Poland

      Badalona , Spain

      San Sebastiu00e1n , Spain

      Valencia , Spain

      Brighton , United Kingdom

      Taunton , United Kingdom

      Cheltenham , United Kingdom

      London , United Kingdom

      Manchester , United Kingdom

      Northwood , United Kingdom

      You can join this study in:

      Study Steps

      How Complex Will My Study Be and What Phases Will I Go Through?

      As a patient participating in the clinical trial, you would need to follow the steps outlined as the inclusion criteria and protocol requirements. Here are the key steps you will need to take:

      1. Provide a signed and dated consent form approved by the Institutional Review Board or Independent Ethics Committee before any study-specific screening procedures.
      2. Have a confirmed histologic diagnosis of high-grade serous, epithelial ovarian, primary peritoneal, or fallopian tube carcinoma.
      3. Have platinum-resistant disease, which is defined as the progression of the disease within six months from the completion of a platinum-containing therapy.
      4. Consent to provide an archival tumor-tissue block or slides. If the archival tumor is unavailable, you may consent to an optional tumor biopsy.
      5. Have a life expectancy of at least three months.
      6. Have at least one lesion that is considered measurable disease by RECIST v1.1 criteria.
      7. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
      8. Be able to comply with the protocol requirements, swallow and retain oral medication, and not have uncontrolled vomiting.
      9. Have received at least one but no more than three lines of prior systemic anticancer therapy, including at least one prior line of platinum therapy, and prior treatment with bevacizumab is required.
      10. Have adequate organ function which meets certain laboratory-test criteria, such as absolute neutrophil count, platelet count, hemoglobin levels, liver enzyme levels, bilirubin levels, albumin levels, and creatinine clearance rates.

      Note that there are also specific exclusion criteria which would determine your eligibility to participate, such as unresolved toxicity from prior therapies, major surgery within 4 weeks prior to randomization, specific tumor histologies, previous treatments with certain drugs, and more. More detailed information regarding the dosing schedule, treatment cycles, or interventions being studied is not listed here but can be found in other sections of the trial protocol.

      Please inform me if you would like to know more about any specific details such as the drug administration schedule or interventions.


      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

      To join the study, you need to have a confirmed histologic diagnosis of one of the following diseases:

      1. High-grade (Grade 3) serous carcinoma
      2. Epithelial ovarian carcinoma
      3. Primary peritoneal carcinoma
      4. Fallopian tube carcinoma

      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      Here’s a list of the inclusion criteria for the clinical trial, along with explanations for any medical terms used:

      1. Signed and dated Institutional Review Board/Independent Ethics Committee-approved informed consent form: You must have provided written consent that is approved by an ethical board, indicating you understand the trial’s procedures and risks.
      2. Confirmed histologic diagnosis of high-grade (Grade 3) serous, epithelial ovarian, primary peritoneal, or fallopian tube carcinoma: A pathological confirmation that you have an advanced form of cancer originating from ovarian, peritoneal, or fallopian tube tissue.
      3. Platinum-resistant disease: Your cancer must have progressed within less than 6 months after completing a platinum-based chemotherapy regimen.
      4. Consent to provide archival tumor-tissue block or slides: You agree to provide samples of your tumor that have been previously removed.
      5. Life expectancy of ≥3 months: You are expected to live at least three more months.
      6. At least one lesion measurable by RECIST v1.1: You must have at least one tumor that can be measured according to the Response Evaluation Criteria In Solid Tumors, which is a standard way to measure how cancer responds to treatment.
      7. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1: This scale measures your daily living abilities. A score of 0 indicates fully active, able to carry on all pre-disease performance without restriction, while 1 indicates some symptoms but nearly fully ambulatory and able to carry out light work.
      8. Able to comply with protocol requirements and swallow/retain oral medication without uncontrolled vomiting: You can follow the study guidelines, take oral medicines, and do not have uncontrollable vomiting.
      9. Received 1 to 3 lines of prior systemic anticancer therapy, including platinum therapy and treatment with bevacizumab.
      10. Adequate organ function as defined by specified laboratory-test criteria: Your blood and organ tests show certain levels that indicate they are functioning well enough for the trial.
      11. Negative pregnancy test for those who can bear children: If you have the potential to become pregnant, you must have a negative pregnancy test and agree to use effective contraceptive methods. Hormonal contraceptives are not allowed.
      12. COVID-19 vaccines are acceptable: If needed, you may take COVID-19 vaccines as part of your treatment in the study.

      Note that the above information has been summarized to help you understand each criterion better.

      What Reasons Could Exclude Me from the Study?

      Exclusion Criteria:

      1. Prior systemic anticancer therapies or radiotherapy toxicity not resolved to ≤Grade 1.
      2. Major surgery within 4 weeks prior to randomization.
      3. Low-grade endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors with these histologies, or low-grade or borderline ovarian tumor.
      4. Primary platinum-refractory disease (no response to or progression ≤1 month after the last platinum-containing chemotherapy).
      5. Lack of prior bevacizumab treatment.
      6. Recent treatment prior to randomization (chemotherapy, immunotherapy, investigational agents, or radiotherapy) within specified windows before the first dose of study drug.
      7. Wide-field radiation to >25% of bone marrow-bearing areas.
      8. Toxicities from previous therapies unresolved to NCI-CTCAE v5.0 ≤Grade 1.
      9. Chronic or frequent oral corticosteroid use for medical conditions.
      10. Severe hypersensitivity or reaction to any of the study drugs.
      11. Concurrent treatment with mifepristone or other glucocorticoid receptor modulators.
      12. Peripheral neuropathy >Grade 1 from any cause.
      13. Pregnancy, lactation, or intention to conceive during the trial timeline.
      14. Significant uncontrolled conditions that may affect trial results or participant safety.
      15. Current chronic/active HIV, hepatitis C virus, or hepatitis B virus infection.
      16. Untreated or symptomatic CNS metastases.
      17. History of other malignancy within 3 years prior to randomization.
      18. Taking strong cytochrome P450 inhibitors/inducers or substrate with a narrow therapeutic index.
      19. Concurrent enrollment in other investigational studies for ovarian, fallopian tube, or primary peritoneal cancer treatment.
      20. Live vaccine received within 30 days prior to the study start date.

      Here are explanations for some of the medical terms in the list:
      Grade 1 toxicity: This refers to mild adverse effects of treatments, per the National Cancer Institute’s guidelines.
      Platinum-refractory disease: A cancer that does not respond to platinum-based chemotherapy.
      Peripheral neuropathy: Nerve damage outside the brain and spinal cord resulting in weakness, numbness, and pain usually in the hands and feet.
      CNS metastases: Cancer that has spread to the central nervous system, which includes the brain and spinal cord.
      Cytochrome P450 (CYP) inhibitor/inducer: These substances can affect the metabolism of certain drugs, potentially causing an increase (inducers) or decrease (inhibitors) in their activity.
      Therapeutic window: The dosage range of a drug that is effective without being toxic.


      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      The drugs involved in this clinical trial are as follows:

      1. Nab-paclitaxel: This is the trade name for the active substance paclitaxel, which has been formulated as albumin-bound nanoparticles (nab) for better solubility and transport. Nab-paclitaxel is used as a chemotherapy drug that disrupts cancer cell growth by inhibiting cell division.
      2. Relacorilant: The active substance in this medication seems to be relacorilant itself as this is not stated as a trade name. Relacorilant is an investigational drug that antagonizes the cortisol receptor (glucocorticoid receptor) which may help in reducing the effects of excess cortisol or glucocorticoid activity associated with certain types of cancer, including various forms of ovarian cancer.

      Have the Medicinal Substances Used in the Trial Been Previously Studied in Medicine?

      The active substances participating in the clinical trial are known to medicine and the medical literature. Here is a list of the substances with a description for each:

      1. Nab-paclitaxel: This is a well-known chemotherapeutic drug used in the treatment of various cancers, including breast cancer, lung cancer, and pancreatic cancer. It is a formulation of paclitaxel, which is a mitotic inhibitor used in cancer chemotherapy, bonded to albumin nanoparticles.
      2. Relacorilant: Relacorilant is a selective glucocorticoid receptor (GR) antagonist. While it may not be as widely recognized as nab-paclitaxel, GR antagonists are investigated for their potential benefits in treating conditions that involve glucocorticoid receptors, such as certain types of cancer.

      In this trial, patients are receiving these substances in specific regimens. Nab-paclitaxel is administered as intravenous (IV) infusion, while relacorilant is administered as capsules for oral dosing.


      Study ID

      CT-EU-00057221

      Recruitment status

      Recruting new patients

      Start of the trial

      2 years ago

      Study phase

      Phase
      III

      Medicinal Product