A Phase 1/2 interventional study of Relacorilant with nab-paclitaxel in Solid Tumors, sponsored by Corcept Therapeutics. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-06.
Sponsored by Corcept Therapeutics · Phase 1/2, Interventional, and Treatment
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 85 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Corcept Therapeutics is the lead sponsor of 73 studies on the registry; 4 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 9 (29%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Relacorilant with nab-paclitaxel
Relacorilant is supplied as capsules for oral dosing. Nab-paclitaxel administered as an IV infusion.
Also known as: Abraxane, Nanoparticle albumin-bound paclitaxel, CORT125134
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.
Time frame: Up to completion of Cycle 1 (up to 28 days)
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.
Time frame: 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)
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).
Time frame: Up to 512 days
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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Up to 512 days
Pharmacokinetics: Area Under the Concentration-time Curve From Zero to 24 Hours (AUC0-24) of Plasma Relacorilant
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
| Milestone | Segment I: Relacorilant 100 mg + Nab-paclitaxel 60 mg/m^2 Continuous Dosing Regimen | Segment I: Relacorilant 100 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen | Segment I: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen | Segment II: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Intermittent Dosing Regimen | Segment II: Relacorilant 200 mg + Nab-paclitaxel 100 mg/m^2 Intermittent Dosing Regimen |
|---|---|---|---|---|---|
| Started | 17 | 40 | 7 | 16 | 5 |
| Completed | 0 | 0 | 0 | 0 | 0 |
| Not completed | 17 | 40 | 7 | 16 | 5 |
| Withdrew: Adverse event | 2 | 3 | 1 | 1 | 3 |
| Withdrew: Physician decision | 0 | 1 | 0 | 0 | 1 |
| Withdrew: Disease progression | 11 | 23 | 4 | 10 | 1 |
| Withdrew: Enrolled not treated | 1 | 5 | 0 | 2 | 0 |
| Withdrew: Other | 2 | 3 | 1 | 0 | 0 |
| Withdrew: Missing | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 5 | 1 | 3 | 0 |
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.
| Participants | Segment I: Relacorilant 100 mg + Nab-paclitaxel 60 mg/m^2 Continuous Dosing Regimen | Segment I: Relacorilant 100 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen | Segment I: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen | Segment II: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Intermittent Dosing Regimen | Segment II: Relacorilant 200 mg + Nab-paclitaxel 100 mg/m^2 Intermittent Dosing Regimen |
|---|---|---|---|---|---|
| Number of Participants With Dose-limiting Toxicity | 0 | 8 | 2 | 2 | 3 |
Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
| Participants | Segment I: Relacorilant 100 mg + Nab-paclitaxel 60 mg/m^2 Continuous Dosing Regimen | Segment I: Relacorilant 100 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen | Segment I: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen | Segment II: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Intermittent Dosing Regimen | Segment II: Relacorilant 200 mg + Nab-paclitaxel 100 mg/m^2 Intermittent Dosing Regimen |
|---|---|---|---|---|---|
| Number of Participants With One or More Adverse Events Related to Treatment With Relacorilant | 13 | 24 | 5 | 13 | 5 |
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).
| Participants | Segment I: Continuous Dosing Regimens | Segment II: Intermittent Dosing Regimens |
|---|---|---|
| Objective Response Rate | 7 | 2 |
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.
| Participants | Segment I: Continuous Dosing Regimens | Segment II: Intermittent Dosing Regimens |
|---|---|---|
| Clinical Benefit Rate | 13 | 6 |
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
| months | Segment I: Continuous Dosing Regimens | Segment II: Intermittent Dosing Regimens |
|---|---|---|
| Duration of Response | 9.7 (5.4 to 10.7) | NA (0.95 to NA) |
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.
| Months | Segment I: Continuous Dosing Regimens | Segment II: Intermittent Dosing Regimens |
|---|---|---|
| Progression-free Survival | 2.8 (2.1 to 4.0) | 3.7 (2.9 to 16.2) |
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.
| Months | Segment I: Continuous Dosing Regimens | Segment II: Intermittent Dosing Regimens |
|---|---|---|
| Overall Survival | 8.3 (5.2 to 10.9) | 16.5 (8.5 to NA) |
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).
| Participants | GR H-score Above the Overall Median | GR H-score Below the Overall Median |
|---|---|---|
| Complete response | 1 | 0 |
| Partial response | 3 | 1 |
| Stable disease | 7 | 7 |
| Progressive disease | 4 | 4 |
| Missing or not evaluable | 1 | 4 |
| ng*h/mL | Segment I: Relacorilant 100 mg + Nab-paclitaxel 60 mg/m^2 Continuous Dosing Regimen | Segment I: Relacorilant 100 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen | Segment I: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen | Segment II: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Intermittent Dosing Regimen | Segment II: Relacorilant 200 mg + Nab-paclitaxel 100 mg/m^2 Intermittent Dosing Regimen |
|---|---|---|---|---|---|
| Pharmacokinetics: Area Under the Concentration-time Curve From Zero to 24 Hours (AUC0-24) of Plasma Relacorilant | 3380 ± 139 | 3780 ± 110 | 7480 ± 50.0 | 3300 ± 104 | 7440 ± 146 |
| ng*h/mL | Segment I: Relacorilant 100 mg + Nab-paclitaxel 60 mg/m^2 Continuous Dosing Regimen | Segment I: Relacorilant 100 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen | Segment I: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen | Segment II: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Intermittent Dosing Regimen | Segment II: Relacorilant 200 mg + Nab-paclitaxel 100 mg/m^2 Intermittent Dosing Regimen |
|---|---|---|---|---|---|
| Pharmacokinetics: AUC0-24 of Plasma Nab-Paclitaxel | 2290 ± 48.5 | 3580 ± 67.5 | 3380 ± 12.7 | 3440 ± 62.8 | 5910 ± 73.7 |
| ng/mL | Segment I: Relacorilant 100 mg + Nab-paclitaxel 60 mg/m^2 Continuous Dosing Regimen | Segment I: Relacorilant 100 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen | Segment I: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen | Segment II: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Intermittent Dosing Regimen | Segment II: Relacorilant 200 mg + Nab-paclitaxel 100 mg/m^2 Intermittent Dosing Regimen |
|---|---|---|---|---|---|
| Pharmacokinetics: Maximum Concentration (Cmax) of Plasma Relacorilant | 363 ± 100 | 423 ± 88.8 | 767 ± 47.4 | 546 ± 89.4 | 897 ± 55.2 |
| ng/mL | Segment I: Relacorilant 100 mg + Nab-paclitaxel 60 mg/m^2 Continuous Dosing Regimen | Segment I: Relacorilant 100 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen | Segment I: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen | Segment II: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Intermittent Dosing Regimen | Segment II: Relacorilant 200 mg + Nab-paclitaxel 100 mg/m^2 Intermittent Dosing Regimen |
|---|---|---|---|---|---|
| Pharmacokinetics: Cmax of Plasma Nab-Paclitaxel | 1810 ± 71.0 | 2660 ± 69.9 | 1560 ± 79.3 | 2600 ± 70.0 | 3070 ± 41.5 |
Collected over 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). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Segment I: Relacorilant 100 mg + Nab-paclitaxel 60 mg/m^2 Continuous Dosing Regimen | 12/14 (85.7%) | 6/14 (42.9%) | 13/14 (92.9%) |
| Segment I: Relacorilant 100 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen | 19/34 (55.9%) | 18/34 (52.9%) | 31/34 (91.2%) |
| Segment I: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen | 5/6 (83.3%) | 5/6 (83.3%) | 6/6 (100%) |
| Segment II: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Intermittent Dosing Regimen | 4/14 (28.6%) | 8/14 (57.1%) | 14/14 (100%) |
| Segment II: Relacorilant 200 mg + Nab-paclitaxel 100 mg/m^2 Intermittent Dosing Regimen | 4/5 (80%) | 3/5 (60%) | 5/5 (100%) |
| Event | Segment I: Relacorilant 100 mg + Nab-paclitaxel 60 mg/m^2 Continuous Dosing Regimen | Segment I: Relacorilant 100 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen | Segment I: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen | Segment II: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Intermittent Dosing Regimen | Segment II: Relacorilant 200 mg + Nab-paclitaxel 100 mg/m^2 Intermittent Dosing Regimen |
|---|---|---|---|---|---|
| UrosepsisInfections and infestations | 0/14 | 0/34 | 0/6 | 0/14 | 1/5 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 2/14 | 0/34 | 1/6 | 1/14 | 1/5 |
| NeutropeniaBlood and lymphatic system disorders | 0/14 | 2/34 | 0/6 | 0/14 | 1/5 |
| Atrial fibrillationCardiac disorders | 2/14 | 0/34 | 0/6 | 0/14 | 1/5 |
| VomitingGastrointestinal disorders | 0/14 | 1/34 | 1/6 | 2/14 | 0/5 |
| PneumoniaInfections and infestations | 0/14 | 1/34 | 1/6 | 0/14 | 0/5 |
| Corneal infectionInfections and infestations | 0/14 | 0/34 | 1/6 | 0/14 | 0/5 |
| EmpyemaInfections and infestations | 0/14 | 0/34 | 1/6 | 0/14 | 0/5 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 1/14 | 1/34 | 1/6 | 0/14 | 0/5 |
| Febrile neutropeniaBlood and lymphatic system disorders | 0/14 | 1/34 | 1/6 | 0/14 | 0/5 |
| Event | Segment I: Relacorilant 100 mg + Nab-paclitaxel 60 mg/m^2 Continuous Dosing Regimen | Segment I: Relacorilant 100 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen | Segment I: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen | Segment II: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Intermittent Dosing Regimen | Segment II: Relacorilant 200 mg + Nab-paclitaxel 100 mg/m^2 Intermittent Dosing Regimen |
|---|---|---|---|---|---|
| FatigueGeneral disorders | 5/14 | 16/34 | 6/6 | 8/14 | 4/5 |
| Neuropathy peripheralNervous system disorders | 3/14 | 7/34 | 5/6 | 3/14 | 3/5 |
| NeutropeniaBlood and lymphatic system disorders | 1/14 | 9/34 | 1/6 | 5/14 | 4/5 |
| NauseaGastrointestinal disorders | 7/14 | 13/34 | 3/6 | 10/14 | 2/5 |
| StomatitisGastrointestinal disorders | 1/14 | 4/34 | 4/6 | 4/14 | 0/5 |
| Decreased appetiteMetabolism and nutrition disorders | 2/14 | 7/34 | 4/6 | 2/14 | 1/5 |
| Nail disorderSkin and subcutaneous tissue disorders | 2/14 | 4/34 | 4/6 | 7/14 | 2/5 |
| Skin hyperpigmentationSkin and subcutaneous tissue disorders | 1/14 | 5/34 | 4/6 | 7/14 | 2/5 |
| CoughRespiratory, thoracic and mediastinal disorders | 2/14 | 3/34 | 4/6 | 5/14 | 1/5 |
| Upper-airway cough syndromeRespiratory, thoracic and mediastinal disorders | 2/14 | 4/34 | 4/6 | 1/14 | 0/5 |
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.
| Age, Continuous(years) | Segment I: Relacorilant 100 mg + Nab-paclitaxel 60 mg/m^2 Continuous Dosing Regimen | Segment I: Relacorilant 100 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen | Segment I: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen | Segment II: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Intermittent Dosing Regimen | Segment II: Relacorilant 200 mg + Nab-paclitaxel 100 mg/m^2 Intermittent Dosing Regimen | Total |
|---|---|---|---|---|---|---|
| Mean | 57.0 ± 10.60 | 60.6 ± 12.81 | 56.8 ± 18.51 | 59.6 ± 12.02 | 64.8 ± 10.21 | 59.7 ± 12.47 |
| Sex: Female, Male(Participants) | Segment I: Relacorilant 100 mg + Nab-paclitaxel 60 mg/m^2 Continuous Dosing Regimen | Segment I: Relacorilant 100 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen | Segment I: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen | Segment II: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Intermittent Dosing Regimen | Segment II: Relacorilant 200 mg + Nab-paclitaxel 100 mg/m^2 Intermittent Dosing Regimen | Total |
|---|---|---|---|---|---|---|
| Female | 9 | 20 | 4 | 14 | 3 | 50 |
| Male | 5 | 14 | 2 | 0 | 2 | 23 |
| Ethnicity (NIH/OMB)(Participants) | Segment I: Relacorilant 100 mg + Nab-paclitaxel 60 mg/m^2 Continuous Dosing Regimen | Segment I: Relacorilant 100 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen | Segment I: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen | Segment II: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Intermittent Dosing Regimen | Segment II: Relacorilant 200 mg + Nab-paclitaxel 100 mg/m^2 Intermittent Dosing Regimen | Total |
|---|---|---|---|---|---|---|
| Hispanic or Latino | 1 | 3 | 2 | 2 | 0 | 8 |
| Not Hispanic or Latino | 13 | 31 | 4 | 12 | 5 | 65 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Segment I: Relacorilant 100 mg + Nab-paclitaxel 60 mg/m^2 Continuous Dosing Regimen | Segment I: Relacorilant 100 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen | Segment I: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen | Segment II: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Intermittent Dosing Regimen | Segment II: Relacorilant 200 mg + Nab-paclitaxel 100 mg/m^2 Intermittent Dosing Regimen | Total |
|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 1 | 3 | 1 | 5 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 2 | 1 | 0 | 1 | 2 | 6 |
| White | 12 | 31 | 4 | 9 | 2 | 58 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 2 | 1 | 1 | 0 | 4 |
| Region of Enrollment(participants) | Segment I: Relacorilant 100 mg + Nab-paclitaxel 60 mg/m^2 Continuous Dosing Regimen | Segment I: Relacorilant 100 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen | Segment I: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen | Segment II: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Intermittent Dosing Regimen | Segment II: Relacorilant 200 mg + Nab-paclitaxel 100 mg/m^2 Intermittent Dosing Regimen | Total |
|---|---|---|---|---|---|---|
| United States | 14 | 34 | 6 | 14 | 5 | 73 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Corcept Therapeutics