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Relacorilante com Nab-Paclitaxel e Gemcitabina em Doentes com Adenocarcinoma Pancreático Metastático

23 de setembro de 2026 atualizado por: Corcept Therapeutics

Um Estudo de Fase 2, de Braço Único, com Relacorilante em Combinação com Nab-Paclitaxel e Gemcitabina em Doentes com Adenocarcinoma Pancreático Metastático Anteriormente Não Tratado

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).

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

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 de estudo

Intervencional

Inscrição (Estimado)

80

Estágio

  • Fase 2

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: N / D
  • Modelo Intervencional: Atribuição sequencial
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.
Medicamento: Relacorilant

Relacorilant will be administered as capsules for oral dosing.

Outros nomes:
  • CORT125134
Medicamento: Nab-paclitaxel

Nab-paclitaxel will be administered via IV infusion.

Medicamento: Gemcitabine

Gemcitabine will be administered via IV infusion.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Number of Patients with 1 or More Adverse Events (AEs) Leading to Study Drug Discontinuations or Dose Modifications (Part 1)
Prazo: 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)
Prazo: 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)
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Maximum Plasma Concentration (Cmax) of Relacorilant (Part 1 and Part 2)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Corcept Therapeutics

Investigadores

  • Diretor de estudo: Danny Nguyen, Corcept Therapeutics

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

27 de janeiro de 2026

Conclusão Primária (Estimado)

1 de setembro de 2027

Conclusão do estudo (Estimado)

1 de setembro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

3 de novembro de 2025

Enviado pela primeira vez que atendeu aos critérios de CQ

20 de novembro de 2025

Primeira postagem (Real)

2 de dezembro de 2025

Atualizações de registro de estudo

Última Atualização Postada (Real)

25 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

23 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • CORT125134-558

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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