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Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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.
  • Drug: 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.
    Other names:
    • CORT125134
  • 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.
  • 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.

Recruiting Locations

Site 02
Scottsdale, Arizona 85258

Site 04
Los Angeles, California 90025

Site 06
Atlanta, Georgia 30322

Site 03
Grand Rapids, Michigan 49503

Site 10
East Brunswick, New Jersey 08816

Site 08
Albany, New York 12206

Site 05
Lake Success, New York 11042

Site 07
Shirley, New York 11967

Site 09
Nashville, Tennessee 37203

Site 01
San Antonio, Texas 78229

More Details

Status
Recruiting
Sponsor
Corcept Therapeutics

Study Contact

Corcept Therapeutics
650-684-0171
corceptstudy558@corcept.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.