Relacorilant With Nab-Paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma

NCT07259317 | Recruiting Phase 2 FDA Drug

• 1 other identifier: CORT125134-558
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 10

Brief 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).

Conditions

Adenocarcinoma; Carcinoma, Pancreatic Ductal

Keywords

Pancreatic; Adenocarcinoma; PDAC; Pancreas

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  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

Secondary Outcomes (11)

• Overall Survival (OS)

  From date of enrollment until the date of death from any cause, whichever comes first, assessed up to 19 months

• Best Overall Response (BOR)

  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

• Objective Response Rate (ORR)

  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)

  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)

  Week 24

Study Arms (1)

Relacorilant in Combination with Nab-paclitaxel and Gemcitabine

EXPERIMENTAL

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: Relacorilant 150 mg once daily (QD); Drug: Nab-paclitaxel 100 mg/m^2; Drug: Gemcitabine 1000 mg/m^2

Interventions

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.

Also known as: CORT125134

Relacorilant in Combination with Nab-paclitaxel and Gemcitabine

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.

Relacorilant in Combination with Nab-paclitaxel and Gemcitabine

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.

Relacorilant in Combination with Nab-paclitaxel and Gemcitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Any major surgery within 4 weeks prior to enrollment
• Prior treatment as follows:
• Radiotherapy, surgery, chemotherapy, immunotherapy, investigational therapy for the treatment of metastatic disease
• 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

Sponsors & Collaborators

• Corcept Therapeutics: lead

Study Sites (10)

Site 02

Scottsdale, Arizona, 85258, United States

RECRUITING

Site 04

Los Angeles, California, 90025, United States

RECRUITING

Site 06

Atlanta, Georgia, 30322, United States

RECRUITING

Site 03

Grand Rapids, Michigan, 49503, United States

RECRUITING

Site 10

East Brunswick, New Jersey, 08816, United States

RECRUITING

Site 08

Albany, New York, 12206, United States

RECRUITING

Site 05

Lake Success, New York, 11042, United States

RECRUITING

Site 07

Shirley, New York, 11967, United States

RECRUITING

Site 09

Nashville, Tennessee, 37203, United States

RECRUITING

Site 01

San Antonio, Texas, 78229, United States

RECRUITING

MeSH Terms

Conditions

Adenocarcinoma; Carcinoma, Pancreatic Ductal

Interventions

relacorilant; 130-nm albumin-bound paclitaxel; Gemcitabine

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Carcinoma, Ductal; Neoplasms, Ductal, Lobular, and Medullary; Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Sachin Pai

  Corcept Therapeutics

  STUDY DIRECTOR

Central Study Contacts

Corcept Therapeutics

CONTACT

650-684-0171; corceptstudy558@corcept.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2025
• First Posted: December 2, 2025
• Study Start: January 27, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)