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NCT02762981

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

Completed Phase 1, PHASE2 Results posted Last updated 6 December 2022
What this trial tests

Phase 1, PHASE2 trial testing Relacorilant with nab-paclitaxel in Solid Tumors in 85 participants. Completed in 12 September 2020.

Timeline
23 May 2016
Primary endpoint
12 May 2020
12 September 2020

Quick facts

Lead sponsorCorcept Therapeutics
PhasePhase 1, PHASE2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment85
Start date23 May 2016
Primary completion12 May 2020
Estimated completion12 September 2020
Sites4 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Corcept Therapeutics — full company profile →

Who can join

18 and older, any sex, with Solid Tumors. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Dose-limiting Toxicity Primary · 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.

GroupValue95% CI
Segment I: Relacorilant 100 mg + Nab-paclitaxel 60 mg/m^2 Continuous Dosing Regimen0
Segment I: Relacorilant 100 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen8
Segment I: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen2
Segment II: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Intermittent Dosing Regimen2
Segment II: Relacorilant 200 mg + Nab-paclitaxel 100 mg/m^2 Intermittent Dosing Regimen3
Number of Participants With One or More Adverse Events Related to Treatment With Relacorilant Secondary · 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.

GroupValue95% CI
Segment I: Relacorilant 100 mg + Nab-paclitaxel 60 mg/m^2 Continuous Dosing Regimen13
Segment I: Relacorilant 100 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen24
Segment I: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen5
Segment II: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Intermittent Dosing Regimen13
Segment II: Relacorilant 200 mg + Nab-paclitaxel 100 mg/m^2 Intermittent Dosing Regimen5
Objective Response Rate Secondary · 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).

GroupValue95% CI
Segment I: Continuous Dosing Regimens7
Segment II: Intermittent Dosing Regimens2
Clinical Benefit Rate Secondary · 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.

GroupValue95% CI
Segment I: Continuous Dosing Regimens13
Segment II: Intermittent Dosing Regimens6
Duration of Response Secondary · 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

GroupValue95% CI
Segment I: Continuous Dosing Regimens9.75.4 – 10.7
Segment II: Intermittent Dosing RegimensNA0.95 – NA
Progression-free Survival Secondary · 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.

GroupValue95% CI
Segment I: Continuous Dosing Regimens2.82.1 – 4.0
Segment II: Intermittent Dosing Regimens3.72.9 – 16.2
Overall Survival Secondary · 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.

GroupValue95% CI
Segment I: Continuous Dosing Regimens8.35.2 – 10.9
Segment II: Intermittent Dosing Regimens16.58.5 – NA
Best Response Rate in Participants With Tumor Glucocorticoid Receptor (GR) Above or Below the Median Overall Level Secondary · 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).

GroupValue95% CI
GR H-score Above the Overall Median1
GR H-score Below the Overall Median0
GR H-score Above the Overall Median3
GR H-score Below the Overall Median1
GR H-score Above the Overall Median7
GR H-score Below the Overall Median7
GR H-score Above the Overall Median4
GR H-score Below the Overall Median4
Pharmacokinetics: Area Under the Concentration-time Curve From Zero to 24 Hours (AUC0-24) of Plasma Relacorilant Secondary · 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
GroupValue95% CI
Segment I: Relacorilant 100 mg + Nab-paclitaxel 60 mg/m^2 Continuous Dosing Regimen3380± 139
Segment I: Relacorilant 100 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen3780± 110
Segment I: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen7480± 50.0
Segment II: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Intermittent Dosing Regimen3300± 104
Segment II: Relacorilant 200 mg + Nab-paclitaxel 100 mg/m^2 Intermittent Dosing Regimen7440± 146
Pharmacokinetics: AUC0-24 of Plasma Nab-Paclitaxel Secondary · 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
GroupValue95% CI
Segment I: Relacorilant 100 mg + Nab-paclitaxel 60 mg/m^2 Continuous Dosing Regimen2290± 48.5
Segment I: Relacorilant 100 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen3580± 67.5
Segment I: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen3380± 12.7
Segment II: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Intermittent Dosing Regimen3440± 62.8
Segment II: Relacorilant 200 mg + Nab-paclitaxel 100 mg/m^2 Intermittent Dosing Regimen5910± 73.7
Pharmacokinetics: Maximum Concentration (Cmax) of Plasma Relacorilant Secondary · 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
GroupValue95% CI
Segment I: Relacorilant 100 mg + Nab-paclitaxel 60 mg/m^2 Continuous Dosing Regimen363± 100
Segment I: Relacorilant 100 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen423± 88.8
Segment I: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen767± 47.4
Segment II: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Intermittent Dosing Regimen546± 89.4
Segment II: Relacorilant 200 mg + Nab-paclitaxel 100 mg/m^2 Intermittent Dosing Regimen897± 55.2
Pharmacokinetics: Cmax of Plasma Nab-Paclitaxel Secondary · 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
GroupValue95% CI
Segment I: Relacorilant 100 mg + Nab-paclitaxel 60 mg/m^2 Continuous Dosing Regimen1810± 71.0
Segment I: Relacorilant 100 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen2660± 69.9
Segment I: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen1560± 79.3
Segment II: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Intermittent Dosing Regimen2600± 70.0
Segment II: Relacorilant 200 mg + Nab-paclitaxel 100 mg/m^2 Intermittent Dosing Regimen3070± 41.5

Adverse events — posted to ClinicalTrials.gov

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). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Segment I: Relacorilant 100 mg + Nab-paclitaxel 60 mg/m^2 Continuous Dosing Regimen
Serious: 6/14 (43%)
Deaths: 12/14
Segment I: Relacorilant 100 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen
Serious: 18/34 (53%)
Deaths: 19/34
Segment I: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen
Serious: 5/6 (83%)
Deaths: 5/6
Segment II: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Intermittent Dosing Regimen
Serious: 8/14 (57%)
Deaths: 4/14
Segment II: Relacorilant 200 mg + Nab-paclitaxel 100 mg/m^2 Intermittent Dosing Regimen
Serious: 3/5 (60%)
Deaths: 4/5

Serious adverse events (44 terms)

ReactionSystemSegment I: Relacorilant 10…Segment I: Relacorilant 10…Segment I: Relacorilant 15…Segment II: Relacorilant 1…Segment II: Relacorilant 2…
ColitisGastrointestinal disorders
Gastrointestinal haemorrhageGastrointestinal disorders
Malignant neoplasm progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps)
VomitingGastrointestinal disorders
Abdominal painGastrointestinal disorders
Pleural effusionRespiratory, thoracic and mediastinal disorders
NeutropeniaBlood and lymphatic system disorders
Pancreatic carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)
Atrial fibrillationCardiac disorders
Small intestinal obstructionGastrointestinal disorders
Abdominal pain upperGastrointestinal disorders
ConstipationGastrointestinal disorders
Intestinal perforationGastrointestinal disorders
Large intestinal obstructionGastrointestinal disorders
NauseaGastrointestinal disorders
Obstruction gastricGastrointestinal disorders
PneumoniaInfections and infestations
CellulitisInfections and infestations
Clostridium difficile infectionInfections and infestations
Corneal infectionInfections and infestations
Device related infectionInfections and infestations
EmpyemaInfections and infestations
Gastroenteritis Escherichia coliInfections and infestations
Retroperitoneal abscessInfections and infestations
SepsisInfections and infestations
Other adverse events (137 terms — click to expand)

ReactionSystemSegment I: Relacorilant 10…Segment I: Relacorilant 10…Segment I: Relacorilant 15…Segment II: Relacorilant 1…Segment II: Relacorilant 2…
FatigueGeneral disorders
NauseaGastrointestinal disorders
VomitingGastrointestinal disorders
DiarrhoeaGastrointestinal disorders
AnaemiaBlood and lymphatic system disorders
RashSkin and subcutaneous tissue disorders
Back painMusculoskeletal and connective tissue disorders
NeutropeniaBlood and lymphatic system disorders
DehydrationMetabolism and nutrition disorders
Urinary tract infectionInfections and infestations
ConstipationGastrointestinal disorders
Decreased appetiteMetabolism and nutrition disorders
AlopeciaSkin and subcutaneous tissue disorders
Nail disorderSkin and subcutaneous tissue disorders
Skin hyperpigmentationSkin and subcutaneous tissue disorders
Neuropathy peripheralNervous system disorders
HeadacheNervous system disorders
Abdominal painGastrointestinal disorders
Abdominal pain upperGastrointestinal disorders
PyrexiaGeneral disorders
HypokalaemiaMetabolism and nutrition disorders
CoughRespiratory, thoracic and mediastinal disorders
StomatitisGastrointestinal disorders
Dry mouthGastrointestinal disorders
Mucosal inflammationGeneral disorders
Oedema peripheralGeneral disorders
HyponatraemiaMetabolism and nutrition disorders
Abnormal loss of weightMetabolism and nutrition disorders
Oedema pheripheralMetabolism and nutrition disorders
Pain in extremityMusculoskeletal and connective tissue disorders
Upper-airway cough syndromeRespiratory, thoracic and mediastinal disorders
DyspnoeaRespiratory, thoracic and mediastinal disorders
HaemorrhoidsGastrointestinal disorders
HypophosphataemiaMetabolism and nutrition disorders
HypomagnesaemiaMetabolism and nutrition disorders
Rash maculo-papularSkin and subcutaneous tissue disorders
AcneSkin and subcutaneous tissue disorders
ArthralgiaMusculoskeletal and connective tissue disorders
MyalgiaMusculoskeletal and connective tissue disorders
DizzinessNervous system disorders

Most-reported serious reactions: Colitis, Gastrointestinal haemorrhage, Malignant neoplasm progression, Vomiting, Abdominal pain, Pleural effusion, Neutropenia, Pancreatic carcinoma.

Data from ClinicalTrials.gov NCT02762981 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Nanoparticles in Clinical Translation for Cancer Therapy.
    Mundekkad D, Cho WC. · · 2022 · cited 146× · PMID 35163607 · DOI 10.3390/ijms23031685
  2. Transcription Factors in Cancer Development and Therapy.
    Vishnoi K, Viswakarma N, Rana A, Rana B. · · 2020 · cited 123× · PMID 32824207 · DOI 10.3390/cancers12082296
  3. TNBC: Potential Targeting of Multiple Receptors for a Therapeutic Breakthrough, Nanomedicine, and Immunotherapy.
    Singh DD, Yadav DK. · · 2021 · cited 76× · PMID 34440080 · DOI 10.3390/biomedicines9080876
  4. Discovery of a Glucocorticoid Receptor (GR) Activity Signature Using Selective GR Antagonism in ER-Negative Breast Cancer.
    West DC, Kocherginsky M, Tonsing-Carter EY, Dolcen DN, et al · · 2018 · cited 63× · PMID 29636357 · DOI 10.1158/1078-0432.ccr-17-2793
  5. Imaging and therapy of ovarian cancer: clinical application of nanoparticles and future perspectives.
    Di Lorenzo G, Ricci G, Severini GM, Romano F, et al · · 2018 · cited 43× · PMID 30214620 · DOI 10.7150/thno.26345
  6. Long non-coding RNAs: implications in targeted diagnoses, prognosis, and improved therapeutic strategies in human non- and triple-negative breast cancer.
    Rodríguez Bautista R, Ortega Gómez A, Hidalgo Miranda A, Zentella Dehesa A, et al · · 2018 · cited 41× · PMID 29983835 · DOI 10.1186/s13148-018-0514-z
  7. High glucocorticoid receptor expression predicts short progression-free survival in ovarian cancer.
    Veneris JT, Darcy KM, Mhawech-Fauceglia P, Tian C, et al · · 2017 · cited 41× · PMID 28456378 · DOI 10.1016/j.ygyno.2017.04.012
  8. Glucocorticoid receptor expression in 20 solid tumor types using immunohistochemistry assay.
    Block TS, Murphy TI, Munster PN, Nguyen DP, et al · · 2017 · cited 36× · PMID 28293120 · DOI 10.2147/cmar.s124475

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Currently open trials in the same condition.

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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02762981.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing