Metastatic Pancreatic Ductal AdenocarcinomaPhase 3RELIANTNCT04329949
Study of Relacorilant in Combination With Nab-Paclitaxel in Patients With Metastatic Pancreatic Ductal Adenocarcinoma
A Phase 3 study testing Relacorilant, 100 mg and 25 mg and Nab-paclitaxel in people with Metastatic Pancreatic Ductal Adenocarcinoma, run by Corcept Therapeutics at 18 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Pancreatic Ductal Adenocarcinoma
- What is being tested?
- Relacorilant, 100 mg and 25 mg and Nab-paclitaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 18 sitesUnited States
- Study dates
- 30 Jun 2020to 25 Mar 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 21Show fewer
- 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:
- Bilirubin ≥1.5 × ULN (Upper Limit of Normal)
- Amylase >2 × ULN and abdominal pain or amylase >3 × ULN (with or without symptoms)
- Fever or signs of infection
- 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.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Site #009
Atlanta, Georgia, 30322
Site #032
Aurora, Colorado, 80045
Site #065
Baltimore, Maryland, 21231
Site #182
Buffalo, New York, 14263
Site #077
Columbus, Ohio, 43210
Site #058
Detroit, Michigan, 48201
Site #171
Duarte, California, 91010
Site #184
Goshen, Indiana, 46526
Site #175
Knoxville, Tennessee, 37920
Site #076
Los Angeles, California, 90095
Site #176
Nashville, Tennessee, 37232
Site #044
New York, New York, 10016
Site #222
New York, New York, 10016
Site #185
Omaha, Nebraska, 68114
Site #172
Pittsburgh, Pennsylvania, 15232
Site #038
Scottsdale, Arizona, 85258
Site #173
Seattle, Washington, 98195
Site #186
Toledo, Ohio, 43614
About this study
Official title: A Phase 3 Study of Relacorilant in Combination With Nab-Paclitaxel in Patients With Metastatic Pancreatic Ductal Adenocarcinoma (RELIANT)
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.
Read the 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 mPDAC who have received at least 2 prior lines of therapy for pancreatic ductal adenocarcinoma 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.
- Being tested
- Relacorilant, 100 mg and 25 mg, Nab-paclitaxel
- Keywords
- Pancreatic Cancer, mPDAC, Metastatic Pancreatic Ductal Adenocarcinoma, Glucocorticoid Receptor, Nab-paclitaxel, GR Antagonist, Relacorilant, Abraxane
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relacorilant, 100 mg and 25 mgDrug
Also called CORT125134
Relacorilant is supplied as capsules for oral dosing.
Nab-paclitaxelDrug
Also called Abraxane
Nab-paclitaxel is administered as IV infusion over 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Relacorilant, 100 mg and 25 mg; Drug: Nab-paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and up to 32 weeks
Secondary outcomes (11)
Objective Response Rate (ORR) Per Investigator Assessment
Percentage of patients with measurable disease at baseline who achieved confirmed CR or PR per RECIST v1.1, as assessed by the Investigator. Tumor assessment consisted of CT scan or, with Sponsor approval, 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 SOD of target lesions.
Measured: Baseline and up to 48 weeks
Best Overall Response (BOR)
To evaluate the best overall response of CR, PR, stable disease (SD), or PD per RECIST v1.1. as assessed by BICR. Tumor assessment consisted of CT scan or, with Sponsor approval, 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 SOD of target lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD was defined as ≥20% increase in the SOD of target lesions or the appearance of one or more new lesions.
Measured: Baseline and up to 32 weeks
Duration of Response (DOR)
To evaluate the duration of response as the time of objective response (CR or PR) to the time of disease progression or death, per RECIST v1.1 as assessed by BICR and the Investigator. Tumor assessment consisted of CT scan or, with Sponsor approval, 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 SOD of target lesions. PD was defined as ≥20% increase in the SOD of target lesions or the appearance of one or more new lesions.
Measured: Time of response up to 32 weeks
Disease Control Rate (DCR)
To evaluate patients disease control rate of CR, PR, or SD at 18 weeks, per RECIST v1.1 as assessed by the Investigator. Tumor assessment consisted of CT scan or, with Sponsor approval, 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 SOD of target lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Measured: Enrollment through 18 weeks
Progression-Free Survival (PFS)
To evaluate PFS as median time to disease progression per RECIST v1.1, or death, as assessed by BICR. Tumor assessment consisted of CT scan or, with Sponsor approval, MRI. Disease progression was defined as ≥20% increase in the SOD of target lesions or the appearance of one or more new lesions.
Measured: Baseline and up to 31 weeks.
Overall Survival (OS)
To evaluate OS as median time to death by any cause.
Measured: Baseline and up to 70 weeks
Progression-Free Survival (PFS)
To evaluate PFS as the percentage of patients who are progression-free at 3, 6, and 12 months per RECIST v1.1, as assessed by BICR. Tumor assessment consisted of CT scan or, with Sponsor approval, MRI. Disease progression was defined as ≥20% increase in the SOD of target lesions or the appearance of one or more new lesions.
Measured: Enrollment through 3 months, 6 months, and 12 months
Overall Survival (OS)
To evaluate OS as the percentage of patients surviving at 3, 6, and 12, months.
Measured: Enrollment through 3 months, 6 months, and 12 months
Cancer Antigen (CA)19-9
To assess cancer antigen 19-9 (CA19-9) response at 8 and 16 weeks in patients who have elevated CA19-9 at baseline. Response was defined as ≥50% reduction in CA19-9.
Measured: Enrollment through 8 weeks and 16 weeks
Tumor Response Per European Organization for Research and Treatment of Cancer (EORTC) Criteria
To assess tumor response based on changes in fluorodeoxyglucose-positron emission tomography (FDG-PET) scan at 6 weeks per the EORTC criteria, as assessed by BICR.
Measured: Enrollment through 6 weeks
Time to Progression (TTP)
To evaluate TTP as median time to disease progression per RECIST v1.1, as assessed by the Investigator. Tumor assessment consisted of CT scan or, with Sponsor approval, MRI. Disease progression was defined as ≥20% increase in the SOD of target lesions or the appearance of one or more new lesions.
Measured: Baseline and up to 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start30 Jun 2020
- Primary completion23 Aug 2021
- Study completion25 Mar 2022
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corcept Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Guyer, PharmD, Study director, Corcept Therapeutics, Menlo Park, CA 94025
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04329949
- Sponsor's protocol ID
- CORT125134-553
- Acronym
- RELIANT
- Status last verified
- Oct 2023
- First submitted
- 13 Mar 2020
- Last updated
- 18 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Study of Relacorilant in Combination With Nab-Paclitaxel in Patients With Metastatic Pancreatic Ductal Adenocarcinoma (RELIANT)
- ClinicalTrials.gov ID
- NCT04329949
- Acronym / sponsor ID
- RELIANT / CORT125134-553
- Keywords
- Pancreatic Cancer, mPDAC, Metastatic Pancreatic Ductal Adenocarcinoma, Glucocorticoid Receptor, Nab-paclitaxel, GR Antagonist, Relacorilant, Abraxane
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 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.
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Corcept TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- 23 Aug 2021 (actual)
- Study completion
- 25 Mar 2022 (actual)
- First posted
- 1 Apr 2020 (actual)
- Results
- Posted 18 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 mPDAC who have received at least 2 prior lines of therapy for pancreatic ductal adenocarcinoma 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Relacorilant with nab-paclitaxel | Experimental | Drug: Relacorilant, 100 mg and 25 mg, Drug: Nab-paclitaxelPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (21 listed)
- 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
- An investigational product, cytotoxic chemotherapy, or targeted agent within 14 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relacorilant, 100 mg and 25 mgAlso: CORT125134Relacorilant is supplied as capsules for oral dosing. | Drug | Relacorilant with nab-paclitaxel |
| Nab-paclitaxelAlso: AbraxaneNab-paclitaxel is administered as IV infusion over 30 minutes on Days 1, 8, and 15 of each 28-day cycle. | Drug | Relacorilant with nab-paclitaxel |
Primary outcome
Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR)
Time frame: Baseline and up to 32 weeks
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.
11 secondary outcomes
Objective Response Rate (ORR) Per Investigator Assessment
Time frame: Baseline and up to 48 weeks
Best Overall Response (BOR)
Time frame: Baseline and up to 32 weeks
Duration of Response (DOR)
Time frame: Time of response up to 32 weeks
Disease Control Rate (DCR)
Time frame: Enrollment through 18 weeks
Progression-Free Survival (PFS)
Time frame: Baseline and up to 31 weeks.
Overall Survival (OS)
Time frame: Baseline and up to 70 weeks
Progression-Free Survival (PFS)
Time frame: Enrollment through 3 months, 6 months, and 12 months
Overall Survival (OS)
Time frame: Enrollment through 3 months, 6 months, and 12 months
Cancer Antigen (CA)19-9
Time frame: Enrollment through 8 weeks and 16 weeks
Tumor Response Per European Organization for Research and Treatment of Cancer (EORTC) Criteria
Time frame: Enrollment through 6 weeks
Time to Progression (TTP)
Time frame: Baseline and up to 32 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Guyer, PharmD study director
Corcept Therapeutics, Menlo Park, CA 94025
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Relacorilant, 100 mg and 25 mg and Nab-paclitaxel in people with Metastatic Pancreatic Ductal Adenocarcinoma, run by Corcept Therapeutics at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) (time frame: Baseline and up to 32 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.