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

NCT ID: NCT07259317

Last Updated: 2026-01-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-27
• Study Completion Date: 2027-07-31

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).

Detailed Description

Study treatment will be comprised of relacorilant, combined with nab-paclitaxel and gemcitabine. Each 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 (100 mg/m^2) and gemcitabine (1000 mg/m^2) infusions. Nab-paclitaxel and gemcitabine will be administered on Days 1, 8, and 15 of each 28-day cycle. Patients will receive study treatment until they reach progressive disease (PD), experience unmanageable toxicity, or until other discontinuation criteria are met.

Conditions

Adenocarcinoma; Carcinoma, Pancreatic Ductal

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Relacorilant in Combination with Nab-paclitaxel and Gemcitabine

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.

Group Type: EXPERIMENTAL

Relacorilant 150 mg once daily (QD)

Intervention Type: 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.

Nab-paclitaxel 100 mg/m^2

Intervention Type: DRUG

Nab-paclitaxel will be administered via intravenous (IV) infusion on Days 1, 8, and 15 of each 28-day cycle.

Gemcitabine 1000 mg/m^2

Intervention Type: DRUG

Gemcitabine will be administered via intravenous (IV) infusion on Days 1, 8, and 15 of each 28-day cycle.

Interventions

Relacorilant 150 mg once daily (QD)

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.

Intervention Type: DRUG

Nab-paclitaxel 100 mg/m^2

Nab-paclitaxel will be administered via intravenous (IV) infusion on Days 1, 8, and 15 of each 28-day cycle.

Intervention Type: DRUG

Gemcitabine 1000 mg/m^2

Gemcitabine will be administered via intravenous (IV) infusion on Days 1, 8, and 15 of each 28-day cycle.

Intervention Type: DRUG

Other Intervention Names

CORT125134

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Corcept Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sachin Pai

Role: STUDY_DIRECTOR

Corcept Therapeutics

Locations

Site 01

San Antonio, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Corcept Therapeutics

Role: CONTACT

corceptstudy558@corcept.com

650-684-0171

Other Identifiers

CORT125134-558

Identifier Type: -

Identifier Source: org_study_id