Study of Relacorilant in Combination With Nab-Paclitaxel in Patients With Metastatic Pancreatic Ductal Adenocarcinoma

NCT04329949 | Terminated Phase 3 Results DMC FDA Drug

• 1 other identifier: CORT125134-553
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 18

Brief Summary

This is a Phase 3, open-label study to evaluate the objective response rate (ORR), in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) treated with relacorilant in combination with nab-paclitaxel, according to blinded independent central review.

Conditions

Metastatic Pancreatic Ductal Adenocarcinoma

Keywords

Pancreatic Cancer; mPDAC; Metastatic Pancreatic Ductal Adenocarcinoma; Glucocorticoid Receptor; Nab-paclitaxel; GR Antagonist; Relacorilant; Abraxane

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR)

  Percentage of patients with measurable disease at baseline who achieved confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, as assessed by Blinded Independent Central Review (BICR). Tumor assessment consisted of computerized tomography (CT) scan or, with Sponsor approval, magnetic resonance imaging (MRI). CR was defined as disappearance of all target lesions; any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \<10 mm. PR was defined as ≥30% decrease in the sum of the diameters (SOD) of target lesions.

  Baseline and up to 32 weeks

Secondary Outcomes (11)

• Objective Response Rate (ORR) Per Investigator Assessment

  Baseline and up to 48 weeks

• Best Overall Response (BOR)

  Baseline and up to 32 weeks

• Duration of Response (DOR)

  Time of response up to 32 weeks

• Disease Control Rate (DCR)

  Enrollment through 18 weeks

• Progression-Free Survival (PFS)

  Baseline and up to 31 weeks.

Study Arms (1)

Relacorilant with nab-paclitaxel

EXPERIMENTAL

Patients will be treated with relacorilant, administered orally, once daily in combination with nab-paclitaxel on Days 1, 8, and 15 of each 28-day cycle.

Drug: Relacorilant, 100 mg and 25 mg; Drug: Nab-paclitaxel

Interventions

Relacorilant, 100 mg and 25 mg DRUG

Relacorilant is supplied as capsules for oral dosing.

Also known as: CORT125134

Relacorilant with nab-paclitaxel

Nab-paclitaxel DRUG

Nab-paclitaxel is administered as IV infusion over 30 minutes on Days 1, 8, and 15 of each 28-day cycle.

Also known as: Abraxane

Relacorilant with nab-paclitaxel

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed PDAC with metastatic disease
• Received at least 2 prior lines of therapy for PDAC in any setting, including at least 1 prior gemcitabine-based therapy and at least 1 prior fluoropyrimidine-based therapy
• Received no more than 4 prior lines of cytotoxic or myelosuppressive therapy for PDAC
• A measurable lesion at baseline (within 21 days prior to the first dose of relacorilant) per RECIST v1.1, as assessed by the Investigator
• Willingness to provide blood samples and tumor tissue (primary or metastatic) for research purposes
• Karnofsky performance status (KPS) score of ≥70
• Adequate gastrointestinal absorption. If the patient has undergone gastric bypass surgery and/or surgery of gastrointestinal or hepatobiliary tract, the patient must demonstrate adequate absorption as evidenced by albumin ≥3.0 g/dL, controlled pancreatic insufficiency (if present), and lack of evidence of malabsorption
• Adequate organ and marrow function (determined through blood and urine tests)

You may not qualify if:

• Pancreatic neuroendocrine tumors, lymphoma of the pancreas, acinar pancreatic cancer, or ampullary cancer
• Known untreated parenchymal brain metastasis or have uncontrolled central nervous system metastases. Patients must not require steroids and must be neurologically stable without corticosteroids for a minimum of 3 weeks prior to Cycle 1 Day 1
• Clinically relevant toxicity from prior systemic cytotoxic therapies or radiotherapy that in the opinion of the Investigator has not resolved to Grade 1 or less prior to enrollment, including peripheral neuropathy that is ongoing and greater than Grade 1 in severity, according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0
• History of hypersensitivity or severe reaction to either relacorilant or nab-paclitaxel, or to similar classes of either drug
• Taken the following medications prior to enrollment:
• An investigational product, cytotoxic chemotherapy, or targeted agent within 14 days
• Radiotherapy within 21 days
• Palliative radiotherapy within 1 week of Cycle 1 Day 1, or if toxicities from radiotherapy are Grade 2 severity or higher or have not recovered to baseline
• Systemic or prescription-strength topical corticosteroids for the purposes of treating a chronic nononcologic indication within 21 days.
• Requirement for treatment with chronic or frequently used oral or inhaled corticosteroids for medical conditions or illnesses (e.g., rheumatoid arthritis, asthma, or immunosuppression after organ transplantation)
• Taking a concomitant medication that is a strong CYP3A (cytochrome P450 3A) or CYP2C8 inhibitor or inducer, or a substrate of CYP3A or CYP2C8 and has a narrow therapeutic window
• Concurrent treatment with mifepristone or other GR antagonists
• Any clinically significant uncontrolled condition(s) or any medical condition which in the opinion of the Investigator places the patient at an unacceptably high risk for toxicities or impair study participation or cooperation
• Any major surgery within 21 days prior to enrollment
• Endoscopic retrograde cholangiopancreatography with persistence of any of the following:

Sponsors & Collaborators

• Corcept Therapeutics: lead

Study Sites (18)

Site #038

Scottsdale, Arizona, 85258, United States

Location

Site #171

Duarte, California, 91010, United States

Location

Site #076

Los Angeles, California, 90095, United States

Location

Site #032

Aurora, Colorado, 80045, United States

Location

Site #009

Atlanta, Georgia, 30322, United States

Location

Site #184

Goshen, Indiana, 46526, United States

Location

Site #065

Baltimore, Maryland, 21231, United States

Location

Site #058

Detroit, Michigan, 48201, United States

Location

Site #185

Omaha, Nebraska, 68114, United States

Location

Site #182

Buffalo, New York, 14263, United States

Location

Site #044

New York, New York, 10016, United States

Location

Site #222

New York, New York, 10016, United States

Location

Site #077

Columbus, Ohio, 43210, United States

Location

Site #186

Toledo, Ohio, 43614, United States

Location

Site #172

Pittsburgh, Pennsylvania, 15232, United States

Location

Site #175

Knoxville, Tennessee, 37920, United States

Location

Site #176

Nashville, Tennessee, 37232, United States

Location

Site #173

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

relacorilant; 130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Limitations and Caveats

The independent data monitoring committee found no safety issues, however the observed response rate did not meet the predefined threshold for continuing the study. The study was terminated by the Sponsor.

Results Point of Contact

• Title: Medical Director
• Organization: Corcept Therapeutics

info@corcept.com

650-327-3270

Study Officials

• William Guyer, PharmD

  Corcept Therapeutics, Menlo Park, CA 94025

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2020
• First Posted: April 1, 2020
• Study Start: June 30, 2020
• Primary Completion: August 23, 2021
• Study Completion: March 25, 2022
• Last Updated: November 18, 2023
• Results First Posted: November 18, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (18)