A Phase II, Single-Arm Trial of Relacorilant in Combination With Nab-Paclitaxel and Gemcitabine in Patients With Previously Untreated Metastatic Pancreatic Adenocarcinoma (TRIDENT)

Study Identifier:
CORT125134-558
CT.gov Identifier:
NCT07259317
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

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Study Summary

This is a Phase 2, single-arm study to evaluate the safety and efficacy of relacorilant in combination with nab-paclitaxel and gemcitabine in patients with previously untreated metastatic pancreatic adenocarcinoma (PDAC).

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Unspecified Cancer
  • Solid Tumor
  • Pancreas
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    II
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: EXPERIMENTAL: Relacorilant in Combination with Nab-paclitaxel and Gemcitabine
    • Read More
  • Drug: The patient will receive relacorilant 150 mg, administered orally under fed conditions, once daily for 3 consecutive days on the day before (excluding Cycle 1, day -1), the day of, and the day after nab-paclitaxel and gemcitabine infusions. Nab-paclitaxel (100 mg/m\^2) and gemcitabine (1000 mg/m\^2) will be administered by IV infusion on Days 1, 8, and 15 of each 28-day cycle. On days when relacorilant, nab-paclitaxel, and gemcitabine are administered, relacorilant will be administered first, then nab-paclitaxel, and gemcitabine last.
  • Drug: Drug: Gemcitabine 1000 mg/m^2
  • Drug: Gemcitabine will be administered via intravenous (IV) infusion on Days 1, 8, and 15 of each 28-day cycle.
  • Drug: Drug: Nab-paclitaxel 100 mg/m^2
  • Drug: Nab-paclitaxel will be administered via intravenous (IV) infusion on Days 1, 8, and 15 of each 28-day cycle.
  • Drug: Drug: Relacorilant 150 mg once daily (QD)
  • Drug: Relacorilant will be administered as capsules for oral dosing on the day before (excluding Cycle 1, Day -1), the day of, and the day after nab-paclitaxel and gemcitabine infusions.
  • Drug: Other Names: CORT125134
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • * Signed and dated informed consent form prior to screening procedures
    • * Histologic diagnosis or cytologic diagnosis of pancreatic adenocarcinoma (PDAC)
    • * Initial diagnosis of metastatic disease occurred ≤6 weeks prior to enrollment in the study
    • * Life expectancy of ≥3 months
    • * Radiographic confirmation of metastatic disease with at least 1 distant tumor metastasis measurable on radiology imaging per RECIST version 1.1 criteria
    • * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
    • * Able to provide informed consent and comply with protocol requirements
    • * Able to swallow and retain oral medication and does not have uncontrolled emesis
    • * Has adequate gastrointestinal absorption
    • * Received no prior systemic anticancer therapy to treat metastatic disease
    • * If a patient received prior treatment of PDAC with chemotherapy, disease progression must have occurred >12 months after completing the last dose, and no persistent treatment-related toxicities can be present.
    • * Adequate organ function
    • * Negative pregnancy test for patients of childbearing potential
    • * Agree to use protocol defined precautions to avoid pregnancy
    Exclusion criteria
    • Any major surgery within 4 weeks prior to enrollment
    • * Prior treatment as follows:
    • 1. Radiotherapy, surgery, chemotherapy, immunotherapy, investigational therapy for the treatment of metastatic disease
    • 2. Systemic, inhaled, or prescription strength topical corticosteroids within 5 times the half-life of the corticosteroid used prior to first dose of study drug
    • * Received gemcitabine or nab-paclitaxel to treat their PDAC
    • * Known germline or somatic breast cancer gene (BRCA) mutation
    • * Peripheral neuropathy from any cause >Grade 1
    • * Medical conditions requiring chronic or frequent treatment with corticosteroids
    • * History of severe hypersensitivity or severe reaction to any of study drugs or their excipients
    • * Concurrent treatment with mifepristone or other glucocorticoid receptor modulators.
    • * Uncontrolled condition(s) which, may confound the results of the trial or interfere with the patient's safety or participation
    • * Active infection with HIV, hepatitis C or hepatitis B virus
    • * Known untreated parenchymal brain metastasis or uncontrolled central nervous system metastases
    • * History of other malignancy within 3 years prior to enrollment
    • * Taking protocol-prohibited medications
    • * Concurrent treatment with other investigational treatment studies for cancer
    • * Has received a live vaccine within 30 days prior to the study start date

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START San Antonio
    San Antonio, TX, United States, 78229
    Investigator
    Drew Rasco
    Status
    Recruiting
    Condition(s) Treated at Site
    Unspecified Cancer
    Solid Tumor
    Pancreas
    Location
    START New York (Long Island)
    Lake Success, NY, United States, 11042
    Investigator
    Geraldine O'Sullivan Coyne
    Status
    Will Be Recruiting
    Condition(s) Treated at Site
    Unspecified Cancer
    Solid Tumor
    Pancreas