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Relacorilant con Nab-Paclitaxel e Gemcitabina in Pazienti con Adenocarcinoma Pancreatico Metastatico

23 settembre 2026 aggiornato da: Corcept Therapeutics

Uno studio di fase 2, a braccio singolo, di Relacorilant in combinazione con Nab-Paclitaxel e Gemcitabina in pazienti con adenocarcinoma pancreatico metastatico precedentemente non trattato

This is a 2-part, Phase 2 study to evaluate the safety, tolerability, dosing, pharmacokinetics (PK), and efficacy of relacorilant in combination with nab-paclitaxel and gemcitabine in chemotherapy-naïve patients with metastatic pancreatic adenocarcinoma (PDAC).

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This study will include 2 parts. In Part 1 (dose finding), approximately 6 patients will be enrolled to individual dose-finding cohorts. Cohorts will receive various dose concentrations of relacorilant, nab-paclitaxel, and gemcitabine at various dosing schedules. In all dose-finding cohorts, relacorilant will be administered orally under fed conditions, once daily for 3 days on the day before (excluding Cycle 1 Day -1), the day of, and the day after nab-paclitaxel and gemcitabine. Enrollment will be paused after each cohort has been filled until the safety review committee (SRC) provides recommendations. If maximum tolerated dose (MTD) criteria are not met in a cohort, then either a dose-finding cohort at a more intense dose and/or schedule may be enrolled, or a dose and schedule at/below the MTD may be selected as the optimal dose and schedule, and Part 2 may be initiated. If MTD criteria are met, then a dose-finding cohort at a less intense dose and/or schedule may be enrolled, or dose-finding may end without proceeding to Part 2.

In Part 2 (expansion), each patient will receive the optimal dose and schedule of relacorilant, nab-paclitaxel, and gemcitabine as identified in Part 1. Analysis of Part 2 will include data for patients from Part 1 who were enrolled in the optimal dose and schedule used in Part 2.

Tipo di studio

Interventistico

Iscrizione (Stimato)

80

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Stati Uniti
    • Arizona
      • Scottsdale, Arizona, Stati Uniti, 85258
        • Reclutamento
        • Site 02
    • California
      • Los Angeles, California, Stati Uniti, 90025
        • Reclutamento
        • Site 04
      • Orange, California, Stati Uniti, 92868
        • Reclutamento
        • Site 12
    • Florida
      • Jacksonville, Florida, Stati Uniti, 32224
        • Reclutamento
        • Site 17
    • Georgia
      • Atlanta, Georgia, Stati Uniti, 30322
        • Reclutamento
        • Site 06
    • Indiana
      • Goshen, Indiana, Stati Uniti, 46526
        • Reclutamento
        • Site 14
    • Kansas
      • Westwood, Kansas, Stati Uniti, 66205
        • Reclutamento
        • Site 15
    • Michigan
      • Grand Rapids, Michigan, Stati Uniti, 49503
        • Reclutamento
        • Site 03
    • Minnesota
      • Rochester, Minnesota, Stati Uniti, 55905
        • Reclutamento
        • Site 18
    • New Jersey
      • East Brunswick, New Jersey, Stati Uniti, 08816
        • Reclutamento
        • Site 10
      • Morristown, New Jersey, Stati Uniti, 07960
        • Reclutamento
        • Site 11
    • New York
      • Albany, New York, Stati Uniti, 12206
        • Reclutamento
        • Site 08
      • Lake Success, New York, Stati Uniti, 11042
        • Ritirato
        • Site 05
      • Shirley, New York, Stati Uniti, 11967
        • Reclutamento
        • Site 07
    • Ohio
      • Cincinnati, Ohio, Stati Uniti, 45219
        • Reclutamento
        • Site 13
      • Toledo, Ohio, Stati Uniti, 43614
        • Reclutamento
        • Site 20
    • Tennessee
      • Nashville, Tennessee, Stati Uniti, 37203
        • Reclutamento
        • Site 09
      • Nashville, Tennessee, Stati Uniti, 37232
        • Reclutamento
        • Site 19
    • Texas
      • Fort Worth, Texas, Stati Uniti, 76104
        • Reclutamento
        • Site 16
      • San Antonio, Texas, Stati Uniti, 78229
        • Reclutamento
        • Site 01

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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 ≤9 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 chemotherapy to treat metastatic PDAC. Treatment of PDAC with a single agent RAS inhibitor is permitted.
  • 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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione sequenziale
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Relacorilant in Combination with Nab-paclitaxel and Gemcitabine

The patient will receive relacorilant 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 intravenous (IV) infusions. Various dose levels and dosing schedules of relacorilant, nab-paclitaxel, and gemcitabine will be evaluated. On days when relacorilant, nab-paclitaxel, and gemcitabine are administered, relacorilant will be administered first, then nab-paclitaxel, and gemcitabine last.
Droga: Relacorilant

Relacorilant will be administered as capsules for oral dosing.

Altri nomi:
  • CORT125134
Droga: Nab-paclitaxel

Nab-paclitaxel will be administered via IV infusion.

Droga: Gemcitabine

Gemcitabine will be administered via IV infusion.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Patients with 1 or More Adverse Events (AEs) Leading to Study Drug Discontinuations or Dose Modifications (Part 1)
Lasso di tempo: Time of first dose up to 30 days after last dose
Time of first dose up to 30 days after last dose
Percent of Patients who Experience Dose Limiting Toxicity (DLT) (Part 1)
Lasso di tempo: Up to 28 days after the first dose of study treatment

The percentage of patients with a DLT is used to estimate maximum tolerated dose (MTD), the most intense dose/schedule among those evaluated at which <33% of patients experience DLT.
Up to 28 days after the first dose of study treatment
Progression-Free Survival (PFS) (Part 2)
Lasso di tempo: From date of enrollment until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 12 months

To evaluate PFS as the time from enrollment until first documented progressive disease (PD) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as determined by the Investigator, or death due to any cause, whichever comes first.
From date of enrollment until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 12 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Maximum Plasma Concentration (Cmax) of Relacorilant (Part 1 and Part 2)
Lasso di tempo: Pre- and postdose on Cycle 1 Day 15 (each cycle is 28 days)
Pre- and postdose on Cycle 1 Day 15 (each cycle is 28 days)
Area Under the Plasma Concentration-time Curve (AUC) of Relacorilant (Part 1 and Part 2)
Lasso di tempo: Pre- and postdose on Cycle 1 Day 15 (each cycle is 28 days)
Pre- and postdose on Cycle 1 Day 15 (each cycle is 28 days)
Cmax of Nab-paclitaxel (Part 1 and Part 2)
Lasso di tempo: At serial timepoints postdose on Cycle 1 Day 15 (each cycle is 28 days)
At serial timepoints postdose on Cycle 1 Day 15 (each cycle is 28 days)
AUC of Nab-paclitaxel (Part 1 and Part 2)
Lasso di tempo: At serial timepoints postdose on Cycle 1 Day 15 (each cycle is 28 days)
At serial timepoints postdose on Cycle 1 Day 15 (each cycle is 28 days)
Overall Survival (OS) (Part 2)
Lasso di tempo: From date of enrollment until the date of death from any cause, whichever comes first, assessed up to 19 months
From date of enrollment until the date of death from any cause, whichever comes first, assessed up to 19 months
Best Overall Response (BOR) (Part 2)
Lasso di tempo: From date of enrollment until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 12 months
From date of enrollment until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 12 months
Number of Patients with 1 or More Adverse Events (Part 2)
Lasso di tempo: Time of first dose up to 30 days after last dose
Time of first dose up to 30 days after last dose
Number of Patients with Treatment-related Adverse Events (Part 2)
Lasso di tempo: Time of first dose up to 30 days after last dose
Time of first dose up to 30 days after last dose
Number of Patients with Adverse Events by Severity (Part 2)
Lasso di tempo: Time of first dose up to 30 days after last dose
Time of first dose up to 30 days after last dose
Number of Patients With 1 or More Adverse Events Leading to Study Drug Discontinuation (Part 2)
Lasso di tempo: Time of first dose up to 30 days after last dose
Time of first dose up to 30 days after last dose
Objective Response Rate (ORR) (Part 2)
Lasso di tempo: From date of enrollment until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 12 months

To evaluate the proportion of patients with measurable disease at Baseline who attain complete response (CR) or partial response (PR) by RECIST version 1.1.
From date of enrollment until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 12 months
Duration of Response (DoR) (Part 2)
Lasso di tempo: From date of first objective response until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 12 months

To evaluate DOR as the time from the first CR or PR to first documented PD or death, whichever comes first.
From date of first objective response until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 12 months
Clinical Benefit Rate (CBR) (Part 2)
Lasso di tempo: Week 24

To evaluate clinical benefit rate as the proportion of patients who attain CR, PR, or stable disease (SD) at Week 24 as per RECIST version 1.1.
Week 24
Cancer Antigen 19-9 (CA19-9) Kinetics (Part 2)
Lasso di tempo: Baseline to Weeks 4, 8, and 16

To evaluate change in CA19-9 from baseline in patients who had an elevated baseline CA19-9 and change in CA19-9 at Weeks 4, 8, and 16 from baseline in all patients.
Baseline to Weeks 4, 8, and 16

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Corcept Therapeutics

Investigatori

  • Direttore dello studio: Danny Nguyen, Corcept Therapeutics

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

27 gennaio 2026

Completamento primario (Stimato)

1 settembre 2027

Completamento dello studio (Stimato)

1 settembre 2027

Date di iscrizione allo studio

Primo inviato

3 novembre 2025

Primo inviato che soddisfa i criteri di controllo qualità

20 novembre 2025

Primo Inserito (Effettivo)

2 dicembre 2025

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

25 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

23 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CORT125134-558

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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