NCT03776812 is a Phase 2 clinical trial of Relacorilant in Recurrent Ovarian Cancer, sponsored by Corcept Therapeutics.

Who is sponsoring NCT03776812?

NCT03776812 is sponsored by Corcept Therapeutics.

What drugs are being tested in NCT03776812?

Interventions in NCT03776812: Relacorilant, Nab-paclitaxel.

What condition does NCT03776812 study?

NCT03776812 studies Recurrent Ovarian Cancer, Recurrent Fallopian Tube Carcinoma, Recurrent Primary Peritoneal Carcinoma.

Is NCT03776812 still recruiting?

NCT03776812 is currently completed. Last updated 7 October 2025.

Are results published for NCT03776812?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-10-07 · How we verify

NCT03776812

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study of Relacorilant in Combination With Nab-Paclitaxel for Patients With Recurrent Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Completed Phase 2 Results posted Last updated 7 October 2025

What this trial tests

Phase 2 trial testing Relacorilant in Recurrent Ovarian Cancer in 178 participants. Completed in 12 July 2023.

Timeline

5 April 2019

Primary endpoint
16 March 2021

12 July 2023

Quick facts

Lead sponsor	Corcept Therapeutics
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	178
Start date	5 April 2019
Primary completion	16 March 2021
Estimated completion	12 July 2023
Sites	24 locations across Italy, Belgium, Canada, United States, Spain

Drugs / interventions tested

Relacorilant — full drug profile →
Nab-paclitaxel (nab-paclitaxel) — full drug profile →

Conditions studied

Recurrent Ovarian Cancer — all drugs for Recurrent Ovarian Cancer →
Recurrent Fallopian Tube Carcinoma — all drugs for Recurrent Fallopian Tube Carcinoma →
Recurrent Primary Peritoneal Carcinoma — all drugs for Recurrent Primary Peritoneal Carcinoma →

Sponsor

Corcept Therapeutics — full company profile →

Who can join

18 and older, female only, with Recurrent Ovarian Cancer or Recurrent Fallopian Tube Carcinoma. 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.

Progression-free Survival (PFS) Primary · Baseline and up to 15 months

To assess time from randomization until the date of first documented progressive disease (PD) by RECIST v1.1 (as determined by the Investigator at the local site), or death due to any cause, whichever occurs first.

Group	Value	95% CI
Arm A: Continuous Relacorilant Dosing	5.29	3.84 – 5.55
Arm B: Intermittent Relacorilant Dosing	5.55	3.68 – 7.20
Arm C: Nab-paclitaxel Comparator	3.76	3.52 – 5.36

Objective Response Rate (ORR) Secondary · Baseline and up to 15 months

To assess the proportion of patients with measurable disease at Baseline who attain complete response (CR) or partial response (PR) by RECIST v1.1 (confirmation not required).

Group	Value	95% CI
Arm A: Continuous Relacorilant Dosing	19
Arm B: Intermittent Relacorilant Dosing	20
Arm C: Nab-paclitaxel Comparator	19

Duration of Response (DOR) Secondary · From first documented response up to 12 months

To assess the time from when response (CR or PR) was first documented to the first objectively documented PD or death (whichever occurs first)

Group	Value	95% CI
Arm A: Continuous Relacorilant Dosing	3.79	2.33 – 5.55
Arm B: Intermittent Relacorilant Dosing	5.55	3.75 – 5.88
Arm C: Nab-paclitaxel Comparator	3.65	2.89 – 5.09

Cancer Antigen 125 (CA-125) Response According to Gynecological Cancer Intergroup Criteria (GCIG) Secondary · Baseline and up to 15 months

To assess the overall CA-125 response per GCIG criteria. Response was defined as ≥50% reduction in CA-125 from a pre-treatment sample. Patients whose CA-125 levels fall within the reference range are classified as complete responders.

Group	Value	95% CI
Arm A: Continuous Relacorilant Dosing	32
Arm B: Intermittent Relacorilant Dosing	34
Arm C: Nab-paclitaxel Comparator	28

Best Overall Response (BOR) Secondary · Baseline and up to 15 months

To assess the best response (CR, PR, stable disease \[SD\], or PD) recorded from the date of randomization until PD/recurrence (or death)

Complete response

Group	Value	95% CI
Arm A: Continuous Relacorilant Dosing	4
Arm B: Intermittent Relacorilant Dosing	1
Arm C: Nab-paclitaxel Comparator	2

Partial response

Group	Value	95% CI
Arm A: Continuous Relacorilant Dosing	15
Arm B: Intermittent Relacorilant Dosing	19
Arm C: Nab-paclitaxel Comparator	17

Stable disease

Group	Value	95% CI
Arm A: Continuous Relacorilant Dosing	23
Arm B: Intermittent Relacorilant Dosing	20
Arm C: Nab-paclitaxel Comparator	21

Progressive disease

Group	Value	95% CI
Arm A: Continuous Relacorilant Dosing	9
Arm B: Intermittent Relacorilant Dosing	14
Arm C: Nab-paclitaxel Comparator	12

Not evaluable

Group	Value	95% CI
Arm A: Continuous Relacorilant Dosing	3
Arm B: Intermittent Relacorilant Dosing	2
Arm C: Nab-paclitaxel Comparator	1

PFS Rate at 6 and 12 Months Secondary · 6 and 12 months

To assess the proportion of patients who have not progressed according to RECIST v1.1 criteria at 6 and 12 months. Values are Kaplan-Meier estimates of the patients progression-free at the time points specified.

6 months

Group	Value	95% CI
Arm A: Continuous Relacorilant Dosing	0.26	0.15 – 0.38
Arm B: Intermittent Relacorilant Dosing	0.40	0.28 – 0.53
Arm C: Nab-paclitaxel Comparator	0.25	0.15 – 0.36

12 months

Group	Value	95% CI
Arm A: Continuous Relacorilant Dosing	0.08	0.02 – 0.18
Arm B: Intermittent Relacorilant Dosing	0.11	0.04 – 0.23
Arm C: Nab-paclitaxel Comparator	0.04	0.01 – 0.12

PFS in Patients Who Cross Over to Continuous Treatment at Time of Initial PD Secondary · Crossover Baseline (Day 50) up to Day 272

To assess the time from crossover Baseline (initial PD) until the earliest date of subsequent PD by RECIST v1.1, as determined by the Investigator at the local site, or death from any cause, whichever comes first.

Group	Value	95% CI
Crossover Patients	2.10	1.87 – 2.50

ORR in Patients Who Cross Over to Continuous Treatment at Time of Initial PD Secondary · Crossover Baseline (Day 50) up to Day 272

To assess the proportion of patients with measurable disease at the crossover Baseline who attain confirmed CR or PR by RECIST v1.1

Group	Value	95% CI
Crossover Patients	0

BOR in Patients Who Cross Over to Continuous Treatment at Time of Initial PD Secondary · Crossover Baseline (Day 50) up to Day 272

To assess the best overall response (CR, PR, SD, or PD) recorded in the crossover period

Complete response

Group	Value	95% CI
Crossover Patients	0

Partial response

Group	Value	95% CI
Crossover Patients	0

Stable disease

Group	Value	95% CI
Crossover Patients	3

Progressive disease

Group	Value	95% CI
Crossover Patients	18

Not evaluable

Group	Value	95% CI
Crossover Patients	0

Overall Survival (OS) Secondary · Up to 31 months

To assess the time from randomization to death by any cause.

Group	Value	95% CI
Arm A: Continuous Relacorilant Dosing	11.30	7.52 – 16.39
Arm B: Intermittent Relacorilant Dosing	13.90	11.07 – 18.43
Arm C: Nab-paclitaxel Comparator	12.19	7.72 – 15.28

Overall Response According to Combined RECIST v1.1 + GCIG Criteria Secondary · Baseline and up to 15 months

To assess the proportion of patients with measurable disease at Baseline who attain confirmed CR or PR by RECIST v1.1 and GCIG criteria. GCIG response was defined as ≥50% reduction in CA-125 from a pre-treatment sample.

Group	Value	95% CI
Arm A: Continuous Relacorilant Dosing	34
Arm B: Intermittent Relacorilant Dosing	36
Arm C: Nab-paclitaxel Comparator	33

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 39 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Arm A: Continuous Relacorilant Dosing

Serious: 30/57 (53%)

Deaths: 53/58

Arm B: Intermittent Relacorilant Dosing

Serious: 15/60 (25%)

Deaths: 49/60

Arm C: Nab-paclitaxel Comparator

Serious: 19/60 (32%)

Deaths: 56/60

Serious adverse events (67 terms)

Reaction	System	Arm A: Continuous Relacori…	Arm B: Intermittent Relaco…	Arm C: Nab-paclitaxel Comp…
Intestinal obstruction	Gastrointestinal disorders	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—
Small intestinal obstruction	Gastrointestinal disorders	—	—	—
Pleural efffusion	Respiratory, thoracic and mediastinal disorders	—	—	—
Constipation	Gastrointestinal disorders	—	—	—
Large intestinal obstruction	Gastrointestinal disorders	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—
General physical health deterioration	General disorders	—	—	—
Cholangitis	Hepatobiliary disorders	—	—	—
Pneumonia	Infections and infestations	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—
Malignant ascites	Gastrointestinal disorders	—	—	—
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—
Cardiac failure	Cardiac disorders	—	—	—
Coronary artery stenosis	Cardiac disorders	—	—	—
Myocardial infarction	Cardiac disorders	—	—	—
Pericardial effusion	Cardiac disorders	—	—	—
Pericarditis	Cardiac disorders	—	—	—
Tachycardia	Cardiac disorders	—	—	—
Vertigo	Ear and labyrinth disorders	—	—	—
Ascites	Gastrointestinal disorders	—	—	—
Abdominal distension	Gastrointestinal disorders	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—

Other adverse events (101 terms — click to expand)

Reaction	System	Arm A: Continuous Relacori…	Arm B: Intermittent Relaco…	Arm C: Nab-paclitaxel Comp…
Nausea	Gastrointestinal disorders	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—
Peripheral sensory neuropathy	Nervous system disorders	—	—	—
Constipation	Gastrointestinal disorders	—	—	—
Asthenia	General disorders	—	—	—
Alopecia	Skin and subcutaneous tissue disorders	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—
Fatigue	General disorders	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—
Stomatitis	Gastrointestinal disorders	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—
Oedema peripheral	General disorders	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—
Hypomagnesaemia	Metabolism and nutrition disorders	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—
Pyrexia	General disorders	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—
Abdominal distension	Gastrointestinal disorders	—	—	—
Nail disorder	Skin and subcutaneous tissue disorders	—	—	—
Lacrimation increased	Eye disorders	—	—	—
Urinary tract infection	Infections and infestations	—	—	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—	—	—
Headache	Nervous system disorders	—	—	—
Onycholysis	Skin and subcutaneous tissue disorders	—	—	—
Leukopenia	Blood and lymphatic system disorders	—	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—
Blood alkaline phosphatase increased	Investigations	—	—	—
Dysgeusia	Nervous system disorders	—	—	—
Paraesthesia	Nervous system disorders	—	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—

Most-reported serious reactions: Intestinal obstruction, Abdominal pain, Small intestinal obstruction, Pleural efffusion, Constipation, Large intestinal obstruction, Vomiting, General physical health deterioration.

Data from ClinicalTrials.gov NCT03776812 adverse events section.

Sponsor's own description

This is a Phase 2, open-label, randomized, 3-arm study to evaluate progression-free survival (PFS) in patients with recurrent platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer treated with intermittent or continuous regimens of relacorilant in combination with nab-paclitaxel compared with patients treated with nab-paclitaxel alone.

Publications & conference data

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

Drug resistance in ovarian cancer: from mechanism to clinical trial.
Wang L, Wang X, Zhu X, Zhong L, et al · · 2024 · cited 139× · PMID 38539161 · DOI 10.1186/s12943-024-01967-3
Relacorilant + Nab-Paclitaxel in Patients With Recurrent, Platinum-Resistant Ovarian Cancer: A Three-Arm, Randomized, Controlled, Open-Label Phase II Study.
Colombo N, Van Gorp T, Matulonis UA, Oaknin A, et al · · 2023 · cited 27× · PMID 37364223 · DOI 10.1200/jco.22.02624
Overcoming Taxane Resistance: Preclinical and Phase 1 Studies of Relacorilant, a Selective Glucocorticoid Receptor Modulator, with Nab-Paclitaxel in Solid Tumors.
Munster PN, Greenstein AE, Fleming GF, Borazanci E, et al · · 2022 · cited 25× · PMID 35583817 · DOI 10.1158/1078-0432.ccr-21-4363
Overcoming the challenges of drug development in platinum-resistant ovarian cancer.
Eskander RN, Moore KN, Monk BJ, Herzog TJ, et al · · 2023 · cited 24× · PMID 37916177 · DOI 10.3389/fonc.2023.1258228
Glucocorticoid receptor antagonism promotes apoptosis in solid tumor cells.
Greenstein AE, Hunt HJ. · · 2021 · cited 24× · PMID 34194622 · DOI 10.18632/oncotarget.27989
Glucocorticoid Receptor Regulates and Interacts with LEDGF/p75 to Promote Docetaxel Resistance in Prostate Cancer Cells.
Sanchez-Hernandez ES, Ochoa PT, Suzuki T, Ortiz-Hernandez GL, et al · · 2023 · cited 11× · PMID 37626856 · DOI 10.3390/cells12162046
Super-enhancer Activates Master Transcription Factor NR3C1 Expression and Promotes 5-FU Resistance in Gastric Cancer.
Yu J, Chen M, Sang Q, Li F, et al · · 2025 · cited 8× · PMID 39731339 · DOI 10.1002/advs.202409050
Management of Advanced Ovarian Cancer: Current Clinical Practice and Future Perspectives.
Papageorgiou D, Liouta G, Pliakou E, Zachariou E, et al · · 2025 · cited 5× · PMID 40722601 · DOI 10.3390/biomedicines13071525

Verify or expand the search:

Other trials of Relacorilant

Trials testing the same drug.

NCT05726292 — A Study of Enzalutamide Plus the Glucocorticoid Receptor Antagonist Relacorilant Versus Placebo for Patients With High-r · Phase 2 · recruiting
NCT05347979 — Effect of Relacorilant on the Pharmacokinetics of the Sensitive P-glycoprotein Substrate Dabigatran Etexilate in Healthy · Phase 1 · completed
NCT04795479 — T/QT Study to Investigate the Effect of Relacorilant on Cardiac Repolarization in Healthy Volunteers · Phase 1 · completed
NCT04373265 — Study of Relacorilant in Combination With Pembrolizumab for Patients With Adrenocortical Carcinoma Which Produces Too Mu · Phase 1 · completed
NCT04308590 — A Study of the Efficacy and Safety of Relacorilant in Patients With Cortisol-Secreting Adrenal Adenomas · Phase 3 · completed

Other recruiting trials for Recurrent Ovarian Cancer

Currently open trials in the same condition.

NCT06769425 — HS-10502 Combination Treatment in Patients With Advanced Solid Tumors · Phase 1 · recruiting
NCT07495384 — Efficacy and Safety of CapsuleX Combined With Cisplatin in Platinum-Resistant Recurrent Ovarian Cancer: A Single-Arm Pro · NA · recruiting
NCT06560112 — An Exploratory, Multi-cohort Phase II Study of Combination Therapy With AK104 and AK112 for Recurrent Ovarian Cancer · Phase 2 · recruiting
NCT05610735 — Combination Therapy for Recurrent Ovarian Cancer · Phase 1, PHASE2 · recruiting
NCT06107868 — Phase 1 Study of RP-6306 With Carboplatin and Paclitaxel in TP53 Ovarian and Uterine Cancer · Phase 1 · active not recruiting

Other Corcept Therapeutics trials

Trials by the same sponsor.

NCT07240116 — Study Evaluating the Bioavailability of Miricorilant With Optional Food Effect Assessment in Healthy Adult Subjects · Phase 1 · completed
NCT06829537 — Study of the Prevalence of Endogenous Hypercortisolism in Patients With Resistant Hypertension (MOMENTUM) · completed
NCT06928779 — Effects of Hepatic Impairment on the Pharmacokinetics of Dazucorilant · Phase 1 · completed
NCT06495944 — Impact of Itraconazole on the Pharmacokinetics and Safety of Dazucorilant in Healthy, Adult Participants · Phase 1 · completed
NCT05772169 — Study to Determine the Prevalence of Hypercortisolism in Patients With Type 2 Diabetes and Treatment With Korlym® (Mifep · Phase 4 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03776812 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Corcept Therapeutics
Last refreshed: 7 October 2025

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/NCT03776812.

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