Trial · NCT02762981

Study to Evaluate Relacorilant (CORT125134) in Combination With Nab-paclitaxel in Participants With Solid Tumors

NCT02762981, Phase 1, Phase 2, Completed, Corcept Therapeutics; results first posted 2022-12-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study to Evaluate Relacorilant (CORT125134) in Combination With Nab-paclitaxel in Participants With Solid Tumors. Trials, record NCT02762981. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02762981

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study to Evaluate Relacorilant (CORT125134) in Combination With Nab-paclitaxel in Participants With Solid Tumors
NCT number: NCT02762981
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 85 participants, actual
Lead sponsor: Corcept Therapeutics
Conditions: Solid Tumors
Interventions: Relacorilant with nab-paclitaxel
First posted: 2016-05-05
Last updated: 2022-12-06
Results first posted: 2022-12-06

Source ClinicalTrials.gov

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Dose-limiting Toxicity	Up to completion of Cycle 1 (up to 28 days)	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.
Secondary	Number of Participants With One or More Adverse Events Related to Treatment With Relacorilant	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)	Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Other	Objective Response Rate	Up to 512 days	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).
Other	Clinical Benefit Rate	Up to 512 days	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.
Other	Duration of Response	From the time of response up to the last disease assessment (up to 512 days)	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
Other	Progression-free Survival	Up to 512 days	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.
Other	Overall Survival	Up to 512 days	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.
Other	Best Response Rate in Participants With Tumor Glucocorticoid Receptor (GR) Above or Below the Median Overall Level	Up to 512 days	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).
Other	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
Other	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

1 to 10 of 12Source ClinicalTrials.gov

See all 12 registered outcomes

Outcomes12

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Dose-limiting Toxicity	Up to completion of Cycle 1 (up to 28 days)	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.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With One or More Adverse Events Related to Treatment With Relacorilant	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)	The safety population was all enrolled participants who received at least 1 dose of relacorilant.	Participants	COUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIED	Objective Response Rate	Up to 512 days	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.	Participants	COUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIED	Clinical Benefit Rate	Up to 512 days	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.	Participants	COUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIED	Duration of Response	From the time of response up to the last disease assessment (up to 512 days)	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.	months	MEDIAN
OTHER_PRE_SPECIFIED	Progression-free Survival	Up to 512 days	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.	Months	MEDIAN
OTHER_PRE_SPECIFIED	Overall Survival	Up to 512 days	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.	Months	MEDIAN
OTHER_PRE_SPECIFIED	Best Response Rate in Participants With Tumor Glucocorticoid Receptor (GR) Above or Below the Median Overall Level	Up to 512 days	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.	Participants	COUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIED	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	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.	ng*h/mL	GEOMETRIC_MEAN
OTHER_PRE_SPECIFIED	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	The population analyzed was participants in the Safety Population with adequate pharmacokinetic data.	ng*h/mL	GEOMETRIC_MEAN

1 to 10 of 12Source ClinicalTrials.gov

See all 12 outcomes

Results by group50

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Number of Participants With Dose-limiting Toxicity	Segment I: Relacorilant 100 mg + Nab-paclitaxel 60 mg/m^2 Continuous Dosing Regimen	0	Participants
Number of Participants With Dose-limiting Toxicity	Segment I: Relacorilant 100 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen	8	Participants
Number of Participants With Dose-limiting Toxicity	Segment I: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen	2	Participants
Number of Participants With Dose-limiting Toxicity	Segment II: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Intermittent Dosing Regimen	2	Participants
Number of Participants With Dose-limiting Toxicity	Segment II: Relacorilant 200 mg + Nab-paclitaxel 100 mg/m^2 Intermittent Dosing Regimen	3	Participants
Number of Participants With One or More Adverse Events Related to Treatment With Relacorilant	Segment I: Relacorilant 100 mg + Nab-paclitaxel 60 mg/m^2 Continuous Dosing Regimen	13	Participants
Number of Participants With One or More Adverse Events Related to Treatment With Relacorilant	Segment I: Relacorilant 100 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen	24	Participants
Number of Participants With One or More Adverse Events Related to Treatment With Relacorilant	Segment I: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen	5	Participants
Number of Participants With One or More Adverse Events Related to Treatment With Relacorilant	Segment II: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Intermittent Dosing Regimen	13	Participants
Number of Participants With One or More Adverse Events Related to Treatment With Relacorilant	Segment II: Relacorilant 200 mg + Nab-paclitaxel 100 mg/m^2 Intermittent Dosing Regimen	5	Participants

1 to 10 of 50Source ClinicalTrials.gov

See all 50 results by group

Participant flow15

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Segment I: Relacorilant 100 mg + Nab-paclitaxel 60 mg/m^2 Continuous Dosing Regimen	17
Overall Study	STARTED	Segment I: Relacorilant 100 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen	40
Overall Study	STARTED	Segment I: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen	7
Overall Study	STARTED	Segment II: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Intermittent Dosing Regimen	16
Overall Study	STARTED	Segment II: Relacorilant 200 mg + Nab-paclitaxel 100 mg/m^2 Intermittent Dosing Regimen	5
Overall Study	COMPLETED	Segment I: Relacorilant 100 mg + Nab-paclitaxel 60 mg/m^2 Continuous Dosing Regimen	0
Overall Study	COMPLETED	Segment I: Relacorilant 100 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen	0
Overall Study	COMPLETED	Segment I: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen	0
Overall Study	COMPLETED	Segment II: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Intermittent Dosing Regimen	0
Overall Study	COMPLETED	Segment II: Relacorilant 200 mg + Nab-paclitaxel 100 mg/m^2 Intermittent Dosing Regimen	0

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events905

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Nausea	Gastrointestinal disorders	Segment I: Relacorilant 100 mg + Nab-paclitaxel 60 mg/m^2 Continuous Dosing Regimen	7	14
other	Nausea	Gastrointestinal disorders	Segment I: Relacorilant 100 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen	13	34
other	Nausea	Gastrointestinal disorders	Segment I: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen	3	6
other	Nausea	Gastrointestinal disorders	Segment II: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Intermittent Dosing Regimen	10	14
other	Nausea	Gastrointestinal disorders	Segment II: Relacorilant 200 mg + Nab-paclitaxel 100 mg/m^2 Intermittent Dosing Regimen	2	5
other	Vomiting	Gastrointestinal disorders	Segment I: Relacorilant 100 mg + Nab-paclitaxel 60 mg/m^2 Continuous Dosing Regimen	6	14
other	Vomiting	Gastrointestinal disorders	Segment I: Relacorilant 100 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen	13	34
other	Vomiting	Gastrointestinal disorders	Segment I: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen	3	6
other	Vomiting	Gastrointestinal disorders	Segment II: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Intermittent Dosing Regimen	8	14
other	Vomiting	Gastrointestinal disorders	Segment II: Relacorilant 200 mg + Nab-paclitaxel 100 mg/m^2 Intermittent Dosing Regimen	3	5

1 to 10 of 905Source ClinicalTrials.gov

See all 905 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Segment I: Relacorilant 100 mg + Nab-paclitaxel 60 mg/m^2 Continuous Dosing Regimen	12	14
Total, all-cause mortality	Segment I: Relacorilant 100 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen	19	34
Total, all-cause mortality	Segment I: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen	5	6
Total, all-cause mortality	Segment II: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Intermittent Dosing Regimen	4	14
Total, all-cause mortality	Segment II: Relacorilant 200 mg + Nab-paclitaxel 100 mg/m^2 Intermittent Dosing Regimen	4	5
Total, other adverse events	Segment I: Relacorilant 100 mg + Nab-paclitaxel 60 mg/m^2 Continuous Dosing Regimen	13	14
Total, other adverse events	Segment I: Relacorilant 100 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen	31	34
Total, other adverse events	Segment I: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen	6	6
Total, other adverse events	Segment II: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Intermittent Dosing Regimen	14	14
Total, other adverse events	Segment II: Relacorilant 200 mg + Nab-paclitaxel 100 mg/m^2 Intermittent Dosing Regimen	5	5

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
35058882	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Segment I: Continuous Dosing Regimens vs Segment II: Intermittent Dosing Regimens: Objective Response Rate	Trial comparisons
Segment I: Continuous Dosing Regimens vs Segment II: Intermittent Dosing Regimens: Clinical Benefit Rate	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02762981

GET https://conductscience.org/api/trials/v1/NCT02762981/results?page=2

API reference For AI assistants