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

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ClinicalTrials.gov Identifier: NCT04329949
Recruitment Status : Active, not recruiting
First Posted : April 1, 2020
Last Update Posted : February 1, 2021
Sponsor:
Information provided by (Responsible Party):
Corcept Therapeutics

Tracking Information
First Submitted Date  ICMJE March 13, 2020
First Posted Date  ICMJE April 1, 2020
Last Update Posted Date February 1, 2021
Actual Study Start Date  ICMJE June 30, 2020
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 31, 2020)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 31, 2020)
  • 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.
  • Best Overall Response (BoR) [ Time Frame: Enrollment through 24 months ]
    To evaluate the best overall response per RESIST v1.1.
  • 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.
  • 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.
  • Progression-Free Survival (PFS) [ Time Frame: Enrollment through 24 months ]
    To evaluate progression-free survival, as assessed by the Investigator
  • Overall Survival (OS) [ Time Frame: Enrollment through 24 months ]
    To evaluate overall survival.
  • 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
  • Overall Survival (OS) [ Time Frame: 3 months, 6 months, and 12 months after Enrollment ]
    To evaluate overall survival at 3, 6, and 12, months.
  • 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.
  • 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)
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Relacorilant in Combination With Nab-Paclitaxel in Patients With Metastatic Pancreatic Ductal Adenocarcinoma
Official Title  ICMJE A Phase 3 Study of Relacorilant in Combination With Nab-Paclitaxel in Patients With Metastatic Pancreatic Ductal Adenocarcinoma (RELIANT)
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Pancreatic Ductal Adenocarcinoma
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.
Interventions:
  • Drug: Relacorilant, 100 mg and 25 mg
  • Drug: Nab paclitaxel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: March 31, 2020)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2022
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04329949
Other Study ID Numbers  ICMJE CORT125134-553
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Corcept Therapeutics
Study Sponsor  ICMJE Corcept Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Andreas Grauer, MD Corcept Therapeutics, Menlo Park, CA 94025
PRS Account Corcept Therapeutics
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP