Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04329949
Recruitment Status : Recruiting
First Posted : April 1, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Corcept Therapeutics

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

Condition or disease Intervention/treatment Phase
Metastatic Pancreatic Ductal Adenocarcinoma Drug: Relacorilant, 100 mg and 25 mg Drug: Nab paclitaxel Phase 3

Detailed Description:

Relacorilant is a small molecule antagonist of the glucocorticoid receptor (GR). The goals of this study are to evaluate the efficacy, safety, and pharmacokinetics (PK) of relacorilant in combination with nab-paclitaxel in the treatment of metastatic pancreatic ductal adenocarcinoma.

Eligible patients are those with metastatic pancreatic adenocarcinoma (mPDAC) who have received at least 2 prior lines of therapy for pancreatic ductal adenocarcinoma (PDAC) in any setting, including at least 1 prior gemcitabine-based therapy and at least 1 prior fluoropyrimidine-based therapy.

Patients will receive treatment until progressive disease (PD) (per RECIST v1.1) as determined by the Investigator, experiencing unmanageable toxicity, or until other treatment discontinuation criteria are met. All patients will be followed for documentation of disease progression and survival information (i.e., date and cause of death) and subsequent treatment.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3 Study of Relacorilant in Combination With Nab-Paclitaxel in Patients With Metastatic Pancreatic Ductal Adenocarcinoma (RELIANT)
Actual Study Start Date : June 30, 2020
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

Arm Intervention/treatment
Experimental: Relacorilant with nab-paclitaxel
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
Relacorilant is supplied as capsules for oral dosing.
Other Name: CORT125134

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




Primary Outcome Measures :
  1. Objective Response Rate (ORR) per Blinded Independent Central Review (BICR) [ Time Frame: Enrollment through 24 months ]
    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 (RESIST) v1.1, according to a Blinded Independent Central Review (BICR).


Secondary Outcome Measures :
  1. Objective Response Rate (ORR) per Investigator Assessment [ Time Frame: Enrollment through 24 months ]
    Percentage of patients with measurable disease at baseline who achieved confirmed complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD) per Response Evaluation Criteria in Solid Tumors (RESIST) v1.1, according to Investigator assessment.

  2. Best Overall Response (BoR) [ Time Frame: Enrollment through 24 months ]
    To evaluate the best overall response per RESIST v1.1.

  3. Duration of Response (DoR) [ Time Frame: Time of response up to 24 months ]
    To evaluate the duration of response according to the Investigator and Blinded Independent Central Review.

  4. Disease Control Rate (DCR) [ Time Frame: 18 weeks from enrollment ]
    To evaluate patients disease control rate or complete response, partial response or stable disease at 18 weeks, as assessed by the Investigator.

  5. Progression-Free Survival (PFS) [ Time Frame: Enrollment through 24 months ]
    To evaluate progression-free survival, as assessed by the Investigator

  6. Overall Survival (OS) [ Time Frame: Enrollment through 24 months ]
    To evaluate overall survival.

  7. Progression-Free Survival (PFS) [ Time Frame: 3 months, 6 months, and 12 months after Enrollment ]
    To evaluate progression-free survival at 3, 6 and 12 months

  8. Overall Survival (OS) [ Time Frame: 3 months, 6 months, and 12 months after Enrollment ]
    To evaluate overall survival at 3, 6, and 12, months.

  9. Cancer Antigen (CA)19-9 [ Time Frame: 8 and 16 weeks from Baseline ]
    To assess cancer antigen 19-9 (CA19-9) response at 8 and 16 weeks, in patients who have elevated CA19-9 at baseline.

  10. Tumor Response per EORTC criteria [ Time Frame: 6 weeks post initiation of treatment ]
    To assess tumor response based on changes in FDG-PET scan at 6 weeks per the European Organization for Research and Treatment of Cancer (EORTC) criteria, according to the Blinded Independent Central Review (BICR)

  11. Time to Progression (TTP) [ Time Frame: From date of first treatment of relicorilant plus nab-paclitaxel until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months ]
    To evaluate the time to progression by comparing duration of disease control on prior nab-paclitaxel therapy (if applicable) and on the most recent therapy (study treatment of relacorilant and Nab-paclitaxel).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria - Patients must have the following:

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)

Exclusion Criteria - Patients must not have the following:

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:

  1. An investigational product, cytotoxic chemotherapy or targeted agent within 14 days.
  2. Radiotherapy within 21 days.
  3. 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.
  4. 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 or CYP2C8 inhibitor or inducer, or a substrate of CYP3A (cytochrome P450 3A) or CYP2C8 (cytochrome P45 2C8) and has a narrow therapeutic window.

Concurrent treatment with mifepristone or other Glucocorticoid Receptor (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:

  1. Bilirubin ≥1.5 × ULN (Upper Limit of Normal)
  2. Amylase >2 × ULN and abdominal pain or amylase >3 × ULN (with or without symptoms)
  3. Fever or signs of infection
  4. Decreasing hemoglobin or signs of blood loss A history of human immunodeficiency virus (HIV) or current chronic/active infection with hepatitis C virus (HCV) or hepatitis B virus (HBV). (Patients with chronic or active hepatitis B as diagnosed by serologic tests are excluded from the study. In equivocal cases, hepatitis B or C polymerase chain reaction results may be performed and must be negative for enrollment.) A rapid decline in KPS score or serum albumin (≥20%), or have progressive pain symptoms indicative of rapid clinical deterioration, in the opinion of the Investigator, prior to enrollment. These patients will become ineligible if rapid decline is observed during the Screening Period.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04329949


Contacts
Layout table for location contacts
Contact: Corcept Therapeutics 650-327-3270 clinicalstudies@corcept.com
Contact: Jyotsna Gupta 650-327-3270 jgupta@corcept.com

Locations
Layout table for location information
United States, Arizona
Site #038 Recruiting
Scottsdale, Arizona, United States, 85258
United States, California
Site #171 Recruiting
Duarte, California, United States, 91010
United States, Colorado
Site #032 Recruiting
Aurora, Colorado, United States, 80045
United States, Georgia
Site #009 Recruiting
Atlanta, Georgia, United States, 30322
United States, Indiana
Site #184 Recruiting
Goshen, Indiana, United States, 46526
United States, Michigan
Site #058 Recruiting
Detroit, Michigan, United States, 48201
United States, Nebraska
Site #185 Recruiting
Omaha, Nebraska, United States, 68114
United States, New York
Site #044 Recruiting
New York, New York, United States, 10016
United States, Ohio
Site #077 Recruiting
Columbus, Ohio, United States, 43210
Site #186 Recruiting
Toledo, Ohio, United States, 43614
United States, Pennsylvania
Site #172 Recruiting
Pittsburgh, Pennsylvania, United States, 15232
United States, Tennessee
Site #175 Recruiting
Knoxville, Tennessee, United States, 37920
Sponsors and Collaborators
Corcept Therapeutics
Investigators
Layout table for investigator information
Study Director: Andreas Grauer, MD Corcept Therapeutics, Menlo Park, CA 94025
Layout table for additonal information
Responsible Party: Corcept Therapeutics
ClinicalTrials.gov Identifier: NCT04329949    
Other Study ID Numbers: CORT125134-553
First Posted: April 1, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Corcept Therapeutics:
Pancreatic Cancer
mPDAC
Metastatic Pancreatic Ductal Adenocarcinoma
Glucocorticoid Receptor
Nab-paclitaxel
GR Antagonist
Relacorilant
Abraxane
Additional relevant MeSH terms:
Layout table for MeSH terms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action