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The purpose of this study was to assess the safety of the combination of relacorilant (CORT125134), a novel glucocorticoid receptor (GR) antagonist, and nab- paclitaxel in participants with solid tumors and to determine the preliminary efficacy of the combination of relacorilant and nab-paclitaxel. The structure for the study was a single arm, non-randomized, open- label, multicenter trial with no control group.
The study consisted of two segments to evaluate alternative dosing schedules of relacorilant administered at escalating dose levels. Segment I was to evaluate a continuous-dosing regimen and Segment II was to evaluate an intermittent-dosing regimen. Enrollment in Segment I and Segment II were mutually exclusive, and the two segments enrolled participants concurrently.
In Segment I continuous-dosing cohorts, participants received a single nab-paclitaxel lead-in infusion on Day 1 of Week -2 before Cycle 1, and oral relacorilant lead-in once-daily of Week -1 before Cycle 1. After the Data Review Committee review of data for 2 dose levels, the nab-paclitaxel lead-in was discontinued. The lead-in period was followed by oral relacorilant administered continuously once daily, in combination with nab-paclitaxel infusions on Days 1, 8, and 15 of each 28-day cycle. Segment 1 enrolled a total of 64 participants.
In Segment II intermittent-dosing cohorts, participants received a single relacorilant lead-in dose on Day -1 before Cycle 1, followed by oral relacorilant, administered intermittently the day before, the day of, and the day after nab-paclitaxel infusions on Days 1, 8, and 15 of each 28-day cycle. Segment II enrolled a total of 21 participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Relacorilant with nab-paclitaxel | Experimental | Participants will be treated with relacorilant in combination with nab-paclitaxel at escalating dose levels in either a Continuous-Dosing Regimen or an Intermittent-Dosing Regimen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Relacorilant with nab-paclitaxel | Drug | Relacorilant is supplied as capsules for oral dosing. Nab-paclitaxel administered as an IV infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose-limiting Toxicity | The Maximum Tolerated Dose and the development regimen of relacorilant with nab-paclitaxel was determined by the number of participants with dose-limiting toxicities as defined in the protocol. | Up to completion of Cycle 1 (up to 28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With One or More Adverse Events Related to Treatment With Relacorilant | Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. | Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | Objective response rate is defined by the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) as best response of complete response (CR) or partial response (PR) from the start of relacorilant or nab-paclitaxel, whichever is earliest, across all time points during study observation period (including both confirmed and unconfirmed responses). | Up to 512 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Corcept Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 038 | Scottsdale | Arizona | 85258 | United States | ||
| 014 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35058882 | Derived | Pivonello R, Munster PN, Terzolo M, Ferrigno R, Simeoli C, Puglisi S, Bali U, Moraitis AG. Glucocorticoid Receptor Antagonism Upregulates Somatostatin Receptor Subtype 2 Expression in ACTH-Producing Neuroendocrine Tumors: New Insight Based on the Selective Glucocorticoid Receptor Modulator Relacorilant. Front Endocrinol (Lausanne). 2022 Jan 4;12:793262. doi: 10.3389/fendo.2021.793262. eCollection 2021. |
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The starting population included all study participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Segment I: Relacorilant 100 mg + Nab-paclitaxel 60 mg/m^2 Continuous Dosing Regimen | Following lead-in, participants received relacorilant 100 mg, administered orally once daily, in combination with nab-paclitaxel 60 mg/m^2 infusions on Days 1, 8, and 15 of each 28-day cycle. |
| FG001 | Segment I: Relacorilant 100 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen | Following lead-in, participants received relacorilant 100 mg, administered orally once daily, in combination with nab-paclitaxel 80 mg/m^2 infusions on Days 1, 8, and 15 of each 28-day cycle. |
| FG002 | Segment I: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen | Following lead-in, participants received relacorilant 150 mg, administered orally once daily, in combination with nab-paclitaxel 80 mg/m^2 infusions on Days 1, 8, and 15 of each 28-day cycle. |
| FG003 | Segment II: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Intermittent Dosing Regimen | Following lead-in, participants received relacorilant 150 mg, administered orally the day before, the day of, and the day after nab-paclitaxel 80 mg/m^2 infusions on Days 1, 8, and 15 of each 28-day cycle. |
| FG004 | Segment II: Relacorilant 200 mg + Nab-paclitaxel 100 mg/m^2 Intermittent Dosing Regimen | Following lead-in, participants received relacorilant 200 mg, administered orally the day before, the day of, and the day after nab-paclitaxel 100 mg/m^2 infusions on Days 1, 8, and 15 of each 28-day cycle. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All enrolled participants who received at least 1 dose of relacorilant. The Statistical Report specified summarization of Baseline Characteristic results by Segment I and Segment II.
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| ID | Title | Description |
|---|---|---|
| BG000 | Segment I: Relacorilant 100 mg + Nab-paclitaxel 60 mg/m^2 Continuous Dosing Regimen | Following lead-in, participants received relacorilant 100 mg, administered orally once daily, in combination with nab-paclitaxel 60 mg/m^2 infusions on Days 1, 8, and 15 of each 28-day cycle. |
| BG001 | Segment I: Relacorilant 100 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Dose-limiting Toxicity | The Maximum Tolerated Dose and the development regimen of relacorilant with nab-paclitaxel was determined by the number of participants with dose-limiting toxicities as defined in the protocol. | The dose-limiting toxicity evaluable population was participants who completed 1 cycle of treatment and assessment or received at least 1 dose of relacorilant and discontinued treatment before completing Cycle 1 due to toxicity. | Posted | Count of Participants | Participants | Up to completion of Cycle 1 (up to 28 days) |
|
Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Segment I: Relacorilant 100 mg + Nab-paclitaxel 60 mg/m^2 Continuous Dosing Regimen | Following lead-in, participants received relacorilant 100 mg, administered orally once daily, in combination with nab-paclitaxel 60 mg/m^2 infusions on Days 1, 8, and 15 of each 28-day cycle. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Corcept Therapeutics | 650-327-3270 | info@corcept.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 13, 2020 | Feb 11, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 14, 2019 | Feb 11, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
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| ID | Term |
|---|---|
| C000633444 | relacorilant |
| C520255 | 130-nm albumin-bound paclitaxel |
| D000068196 | Albumin-Bound Paclitaxel |
| D013660 | Taxes |
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 |
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|
| Clinical Benefit Rate | Clinical benefit rate is defined as the participants who have achieved CR or PR (including both confirmed and unconfirmed responses), or stable disease for 16 weeks or greater. | Up to 512 days |
| Duration of Response | Duration of response (DOR) is defined as the date that criteria are met for CR or PR until the first date that progressive disease or death is objectively documented, whichever occurs first. Participants with no documentation of disease progression or death on-study are censored at the date of last available tumor assessment | From the time of response up to the last disease assessment (up to 512 days) |
| Progression-free Survival | Progression-free survival is defined as the time from date of first dose of relacorilant or nab-paclitaxel, whichever is earliest, to the date of documented disease progression per RECIST v1.1 or death for any cause, whichever occurs first. Participants with no documentation of disease progression or death on-study are censored at the date of last available tumor assessment. | Up to 512 days |
| Overall Survival | Overall survival is defined as the time from date of the first dose of relacorilant or nab paclitaxel, whichever is earliest, to the date of death for any cause. Participants with no documentation of death on-study are censored at the date at which they are last known to be alive. | Up to 512 days |
| Best Response Rate in Participants With Tumor Glucocorticoid Receptor (GR) Above or Below the Median Overall Level | Best response is defined by RECIST v1.1 as the best response recorded from the date of the first dose of relacorilant or nab-paclitaxel, whichever is earliest, across all time points during study observation period (including both confirmed and unconfirmed responses). | Up to 512 days |
| Pharmacokinetics: Area Under the Concentration-time Curve From Zero to 24 Hours (AUC0-24) of Plasma Relacorilant | Segment I: before dosing and up to 24 hours after dosing on Cycle 1 Day 8; Segment II: before dosing and up to 24 hours after dosing on Cycle 1 Day 1 |
| Pharmacokinetics: AUC0-24 of Plasma Nab-Paclitaxel | Segment I: before dosing and up to 24 hours after dosing on Cycle 1 Day 8; Segment II: before dosing and up to 24 hours after dosing on Cycle 1 Day 1 |
| Pharmacokinetics: Maximum Concentration (Cmax) of Plasma Relacorilant | Segment I: before dosing and up to 24 hours after dosing on Cycle 1 Day 8; Segment II: before dosing and up to 24 hours after dosing on Cycle 1 Day 1 |
| Pharmacokinetics: Cmax of Plasma Nab-Paclitaxel | Segment I: before dosing and up to 24 hours after dosing on Cycle 1 Day 8; Segment II: before dosing and up to 24 hours after dosing on Cycle 1 Day 1 |
| San Francisco |
| California |
| 94143 |
| United States |
| 001 | Chicago | Illinois | 60637 | United States |
| 013 | Ogden | Utah | 84403 | United States |
| Physician Decision |
|
| Disease progression |
|
| Enrolled not treated |
|
| Other |
|
| Missing |
|
| Withdrawal by Subject |
|
Following lead-in, participants received relacorilant 100 mg, administered orally once daily, in combination with nab-paclitaxel 80 mg/m^2 infusions on Days 1, 8, and 15 of each 28-day cycle. |
| BG002 | Segment I: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen | Following lead-in, participants received relacorilant 150 mg, administered orally once daily, in combination with nab-paclitaxel 80 mg/m^2 infusions on Days 1, 8, and 15 of each 28-day cycle. |
| BG003 | Segment II: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Intermittent Dosing Regimen | Following lead-in, participants received relacorilant 150 mg, administered orally the day before, the day of, and the day after nab-paclitaxel 80 mg/m^2 infusions on Days 1, 8, and 15 of each 28-day cycle. |
| BG004 | Segment II: Relacorilant 200 mg + Nab-paclitaxel 100 mg/m^2 Intermittent Dosing Regimen | Following lead-in, participants received relacorilant 200 mg, administered orally the day before, the day of, and the day after nab-paclitaxel 100 mg/m^2 infusions on Days 1, 8, and 15 of each 28-day cycle. |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Segment I: Relacorilant 100 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen | Following lead-in, participants received relacorilant 100 mg, administered orally once daily, in combination with nab-paclitaxel 80 mg/m^2 infusions on Days 1, 8, and 15 of each 28-day cycle. |
| OG002 | Segment I: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen | Following lead-in, participants received relacorilant 150 mg, administered orally once daily, in combination with nab-paclitaxel 80 mg/m^2 infusions on Days 1, 8, and 15 of each 28-day cycle. |
| OG003 | Segment II: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Intermittent Dosing Regimen | Following lead-in, participants received relacorilant 150 mg, administered orally the day before, the day of, and the day after nab-paclitaxel 80 mg/m^2 infusions on Days 1, 8, and 15 of each 28-day cycle. |
| OG004 | Segment II: Relacorilant 200 mg + Nab-paclitaxel 100 mg/m^2 Intermittent Dosing Regimen | Following lead-in, participants received relacorilant 200 mg, administered orally the day before, the day of, and the day after nab-paclitaxel 100 mg/m^2 infusions on Days 1, 8, and 15 of each 28-day cycle. |
|
|
| Secondary | Number of Participants With One or More Adverse Events Related to Treatment With Relacorilant | Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. | The safety population was all enrolled participants who received at least 1 dose of relacorilant. | Posted | Count of Participants | Participants | Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years) |
|
|
|
| Other Pre-specified | Objective Response Rate | Objective response rate is defined by the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) as best response of complete response (CR) or partial response (PR) from the start of relacorilant or nab-paclitaxel, whichever is earliest, across all time points during study observation period (including both confirmed and unconfirmed responses). | All enrolled participants who received at least 1 dose of relacorilant. The Statistical Plan specified summarization of Objective Response Rate results by Segment I and Segment II. | Posted | Count of Participants | Participants | Up to 512 days |
|
|
|
| Other Pre-specified | Clinical Benefit Rate | Clinical benefit rate is defined as the participants who have achieved CR or PR (including both confirmed and unconfirmed responses), or stable disease for 16 weeks or greater. | All enrolled participants who received at least 1 dose of relacorilant. The Statistical Plan specified summarization of Clinical Benefit Rate results by Segment I and Segment II. | Posted | Count of Participants | Participants | Up to 512 days |
|
|
|
| Other Pre-specified | Duration of Response | Duration of response (DOR) is defined as the date that criteria are met for CR or PR until the first date that progressive disease or death is objectively documented, whichever occurs first. Participants with no documentation of disease progression or death on-study are censored at the date of last available tumor assessment | All enrolled participants who received at least 1 dose of relacorilant. This outcome measure assessed participants with confirmed responses to treatment. The Statistical Plan specified summarization of Duration of Response results by Segment I and Segment II. | Posted | Median | 95% Confidence Interval | months | From the time of response up to the last disease assessment (up to 512 days) |
|
|
|
| Other Pre-specified | Progression-free Survival | Progression-free survival is defined as the time from date of first dose of relacorilant or nab-paclitaxel, whichever is earliest, to the date of documented disease progression per RECIST v1.1 or death for any cause, whichever occurs first. Participants with no documentation of disease progression or death on-study are censored at the date of last available tumor assessment. | All enrolled participants who received at least 1 dose of relacorilant. The Statistical Plan specified summarization of Progression-free Survival results by Segment I and Segment II. | Posted | Median | 95% Confidence Interval | Months | Up to 512 days |
|
|
|
| Other Pre-specified | Overall Survival | Overall survival is defined as the time from date of the first dose of relacorilant or nab paclitaxel, whichever is earliest, to the date of death for any cause. Participants with no documentation of death on-study are censored at the date at which they are last known to be alive. | All enrolled participants who received at least 1 dose of relacorilant. The Statistical Plan specified summarization of Overall Survival results by Segment I and Segment II. | Posted | Median | 95% Confidence Interval | Months | Up to 512 days |
|
|
|
| Other Pre-specified | Best Response Rate in Participants With Tumor Glucocorticoid Receptor (GR) Above or Below the Median Overall Level | Best response is defined by RECIST v1.1 as the best response recorded from the date of the first dose of relacorilant or nab-paclitaxel, whichever is earliest, across all time points during study observation period (including both confirmed and unconfirmed responses). | The population was all enrolled participants who received at least 1 dose of relacorilant and had tumor biopsy tissue assessed for GR. These data were planned to be summarized by GR H-score category: above or below the overall median value. | Posted | Count of Participants | Participants | Up to 512 days |
|
|
|
| Other Pre-specified | Pharmacokinetics: Area Under the Concentration-time Curve From Zero to 24 Hours (AUC0-24) of Plasma Relacorilant | The population analyzed was participants in the Safety Population with adequate pharmacokinetic data. One participant in the Segment II: relacorilant 150 mg + nab-paclitaxel 80 mg/m^2 intermittent dosing group had insufficient data to evaluate AUC0-24 for relacorilant. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Segment I: before dosing and up to 24 hours after dosing on Cycle 1 Day 8; Segment II: before dosing and up to 24 hours after dosing on Cycle 1 Day 1 |
|
|
|
| Other Pre-specified | Pharmacokinetics: AUC0-24 of Plasma Nab-Paclitaxel | The population analyzed was participants in the Safety Population with adequate pharmacokinetic data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Segment I: before dosing and up to 24 hours after dosing on Cycle 1 Day 8; Segment II: before dosing and up to 24 hours after dosing on Cycle 1 Day 1 |
|
|
|
| Other Pre-specified | Pharmacokinetics: Maximum Concentration (Cmax) of Plasma Relacorilant | The population analyzed was participants in the Safety Population with adequate pharmacokinetic data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Segment I: before dosing and up to 24 hours after dosing on Cycle 1 Day 8; Segment II: before dosing and up to 24 hours after dosing on Cycle 1 Day 1 |
|
|
|
| Other Pre-specified | Pharmacokinetics: Cmax of Plasma Nab-Paclitaxel | The population analyzed was participants in the Safety Population with adequate pharmacokinetic data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Segment I: before dosing and up to 24 hours after dosing on Cycle 1 Day 8; Segment II: before dosing and up to 24 hours after dosing on Cycle 1 Day 1 |
|
|
|
| 12 |
| 14 |
| 6 |
| 14 |
| 13 |
| 14 |
| EG001 | Segment I: Relacorilant 100 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen | Following lead-in, participants received relacorilant 100 mg, administered orally once daily, in combination with nab-paclitaxel 80 mg/m^2 infusions on Days 1, 8, and 15 of each 28-day cycle. | 19 | 34 | 18 | 34 | 31 | 34 |
| EG002 | Segment I: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen | Following lead-in, participants received relacorilant 150 mg, administered orally once daily, in combination with nab-paclitaxel 80 mg/m^2 infusions on Days 1, 8, and 15 of each 28-day cycle. | 5 | 6 | 5 | 6 | 6 | 6 |
| EG003 | Segment II: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Intermittent Dosing Regimen | Following lead-in, participants received relacorilant 150 mg, administered orally the day before, the day of, and the day after nab-paclitaxel 80 mg/m^2 infusions on Days 1, 8, and 15 of each 28-day cycle. | 4 | 14 | 8 | 14 | 14 | 14 |
| EG004 | Segment II: Relacorilant 200 mg + Nab-paclitaxel 100 mg/m^2 Intermittent Dosing Regimen | Following lead-in, participants received relacorilant 200 mg, administered orally the day before, the day of, and the day after nab-paclitaxel 100 mg/m^2 infusions on Days 1, 8, and 15 of each 28-day cycle. | 4 | 5 | 3 | 5 | 5 | 5 |
| Abdominal pain | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Intestinal perforation | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Obstruction gastric | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Clostridium difficile infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Corneal infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Empyema | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Gastroenteritis Escherichia coli | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Retroperitoneal abscess | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Splenic infarction | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
|
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
|
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
|
| Transfusion-related acute lung injury | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment |
|
| Cerebral artery stenosis | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Dysgeusia | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Throat irritation | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Anal incontinence | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Anorectal discomfort | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Faeces soft | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Gastrointestinal stoma complication | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Tongue disorder | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| Chills | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| Early satiety | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| Pain | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| Oedema | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| Face oedema | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| Hot flush | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
|
| Abnormal loss of weight | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
|
| Oedema pheripheral | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Nail discolouration | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Nail bed disorder | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Onychomadesis | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Skin abrasion | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Skin mass | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Cognitive disorder | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Insomnia | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Urinary incontinence | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Apnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Candida infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
|
| Disturbance in attention | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA (19.0) | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA (19.0) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (19.0) | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA (19.0) | Systematic Assessment |
|
| Blood potassium increased | Investigations | MedDRA (19.0) | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA (19.0) | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
|
| Oedema peripheral | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA (19.0) | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA (19.0) | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA (19.0) | Systematic Assessment |
|
| Eye disorder | Eye disorders | MedDRA (19.0) | Systematic Assessment |
|
| Visual acuity reduced | Eye disorders | MedDRA (19.0) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
|
| Blister | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
|
| Nocturia | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
|
| Micturition urgency | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
|
| Urinary tract infection | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
|
| Cerumen impaction | Ear and labyrinth disorders | MedDRA (19.0) | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA (19.0) | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment |
|
| Vaginal discharge | Reproductive system and breast disorders | MedDRA (19.0) | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA (19.0) | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
|
| Bloody discharge | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
|
Corcept Therapeutics as the Sponsor, has a proprietary interest in this study. Authorship and manuscript composition will reflect joint cooperation between multiple Investigators and sites and Corcept personnel. Authorship will be established before the writing of the manuscript. As this study involves multiple centers, no individual publications will be allowed before completion of the final report of the multicenter study except as agreed with Corcept.
| D012871 |
| Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D010051 | Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| Stable disease |
|
| Progressive disease |
|
| Missing or not evaluable |
|