Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

All Conditions

Neoplasms

Symptoms and General Pathology

Heart and Blood Diseases

Rare Diseases

Diabetes Mellitus, Type 2

Carcinoma

Diabetes Mellitus

Syndrome

Hypertension

Cushing Syndrome

Adrenocortical Hyperfunction

Facies

Glucose Intolerance

Hyperglycemia

Adrenocortical Carcinoma

Endocrine System Diseases

Adrenal Gland Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Adrenal Cortex Neoplasms

Adrenal Gland Neoplasms

Endocrine Gland Neoplasms

Adrenal Cortex Diseases

Cushing's Syndrome

Hyperadrenalism

Anti-Inflammatory Agents

All Drugs and Chemicals

Antineoplastic Agents

Vasoconstrictor Agents

Respiratory System Agents

Hydrocortisone

Hydrocortisone 17-butyrate 21-propionate

Hydrocortisone acetate

Hydrocortisone hemisuccinate

Hormones

Pembrolizumab

Epinephrine

Glucocorticoids

Racepinephrine

Epinephryl borate

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Participants will be treated on Day -3 to Day 1 (Cohort 1 under fasting conditions) or Day -6 to Day 1 (Cohort 2 under fed conditions) for Cycle 1 only. During the lead-in period, 300 mg relacorilant will be administered daily for 4 -7 days. Patients will receive their first pembrolizumab infusion on Cycle 1 Day 1. The participants will then receive combined treatment from Cycle 1 Day 1 until confirmed PD or unacceptable toxicity. Pembrolizumab will be administered every 6 weeks (on Day 1 of each 42-day cycle) and relacorilant will be administered daily. Optional Cohort 3 will lead-in with 400 mg relacorilant once daily for 7 days and combined treatment of relacorilant and pembrolizumab, depending on PD and toxicity.

Relacorilant, 100 mg soft gel capsules orally once daily

Relacorilant

Pembrolizumab 400 mg infusion every 6 weeks

Andreas G Moraitis, MD

This study will investigate the safety and efficacy of Relacorilant in combination with Pembrolizumab for Patients with Adrenocortical Carcinoma which Produces Too Much Stress Hormone (Cortisol).

Relacorilant is a small molecule antagonist of the glucocorticoid receptor (GR).

The goal of this study is to assess the safety and efficacy of relacorilant when given in combination with pembrolizumab in patients with advanced adrenocortical carcinoma (ACC) which produces too much stress hormone (cortisol). Too much stress hormone (cortisol) is also called glucocorticoid (GC) excess.

Eligible patients are those with advanced ACC that produces too much cortisol.

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

Study of Relacorilant in Combination With Pembrolizumab for Patients With Adrenocortical Carcinoma Which Produces Too Much Stress Hormone (Cortisol)

A Phase 1b, Open-Label Study of Relacorilant in Combination With Pembrolizumab for Patients With Adrenocortical Carcinoma With Excess Glucocorticoid Production

Evaluate the percentage of patients with a dose-limiting toxicity

Evaluate the non-progression rate (NPR) per RECIST v1.1

Evaluate progression-free survival (PFS) per RECIST v1.1

Adverse events (AEs) by severity grade using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0)

Plasma concentrations of relacorilant in combination with pembrolizumab will be calculated in patients with advanced ACC and glucocorticoid excess

Corcept Therapeutics

Digestive System Diseases

Pancreatic Neoplasms

Pancreatic Cancer

Paclitaxel

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

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.

Relacorilant is supplied as capsules for oral dosing.

Relacorilant, 100 mg and 25 mg

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

Nab-paclitaxel

William Guyer, PharmD

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.

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

A Phase 3 Study of Relacorilant in Combination With Nab-Paclitaxel in Patients With Metastatic Pancreatic Ductal Adenocarcinoma (RELIANT)

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.

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.

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.

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.

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.

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.

To evaluate OS as median time to death by any cause.

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.

To evaluate OS as the percentage of patients surviving at 3, 6, and 12, months.

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.

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.

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.

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.

Relacorilant, 100 mg and 25 mg: Relacorilant is supplied as capsules for oral dosing.

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

Relacorilant With Nab-paclitaxel

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

Relacorilant, 100 mg and 25 mg: Relacorilant was supplied as capsules for oral dosing.

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

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

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.

Medical Director

Complete response

Partial response

No response

Intent-to-Treat (ITT) Population: Patients enrolled and treated with at least 1 dose of study treatment

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

Objective Response Rate (ORR) Per Investigator Assessment

Evaluable Population: Patients in the ITT population who had at least 1 post-baseline radiographic tumor assessment

Best Overall Response (BOR)

This outcome was not analyzed because the response rate was 0%.

Duration of Response (DOR)

Disease Control Rate (DCR)

Progression-Free Survival (PFS)

Overall Survival (OS)

3 months

6 months

12 months

8 weeks

16 weeks

Patients in the ITT population who had elevated CA19-9 at Baseline

Cancer Antigen (CA)19-9

Complete metabolic response

Partial metabolic response

Stable metabolic disease

Progressive metabolic disease

Patients in the ITT Population with measurable disease at baseline by FDG-PET evaluation

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Relacorilant in Combination With Pembrolizumab for Patients With Adrenocortical Carcinoma Which Produces Too Much Stress Hormone (Cortisol)	NCT04373265	Adrenocortical ...	Relacorilant Pembrolizumab	18 Years -	Corcept Therapeutics
Study of Relacorilant in Combination With Nab-Paclitaxel in Patients With Metastatic Pancreatic Ductal Adenocarcinoma	NCT04329949	Metastatic Panc...	Relacorilant, 1... Nab-paclitaxel	18 Years -	Corcept Therapeutics
Study of Relacorilant in Combination With Nab-Paclitaxel in Patients With Metastatic Pancreatic Ductal Adenocarcinoma	NCT04329949	Metastatic Panc...	Relacorilant, 1... Nab-paclitaxel	18 Years -	Corcept Therapeutics

Spots Global Cancer Trial Database for gr antagonist