A Phase 3 interventional study of Relacorilant 150 mg and Nab-paclitaxel 80 mg/m^2 in Ovarian Neoplasm, Fallopian Tube Neoplasms and Peritoneal Neoplasms, sponsored by Corcept Therapeutics. Active, not recruiting at 116 sites in 14 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Corcept Therapeutics · Phase 3, Interventional, and Treatment
Olawaiye AB, Gladieff L, O'Malley DM, Kim JW, Garbaos G, Salutari V, Gilbert L, Mileshkin L, Devaux A, Hopp E, Lee YJ, Oaknin A, Scaranti M, Kim BG, Colombo N,…PubMed 40473448 ↗; 1 more. 2 publications citing this study linked from PubMed
Among 15 studies testing Albumin-Bound Paclitaxel in Ovarian Neoplasms — 2 open to participants now, 3 under way, 1 of them phase 3. Albumin-Bound Paclitaxel · Ovarian Neoplasms.
Among the 15 studies testing Albumin-Bound Paclitaxel in Ovarian Neoplasms, this one has the largest enrollment, is one of 5 that started in 2022, is the only one in phase 3, and was the 12th registered.
3,381 studies on the registry are indexed under Ovarian Neoplasms; 790 are open to participants now.
This study's enrollment of 381 is above the median of 54 across 2,548 interventional studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →2 of the 15 studies testing Albumin-Bound Paclitaxel in Ovarian Neoplasms are open now, in 1 country. Each count lists the studies.
Albumin-Bound Paclitaxel: first FDA approval 2005 (ABRAXANE), first EMA approval 2008. What it is approved for, and how studies give it, is on its page →
Of the 606 Ovarian Neoplasms studies recruiting now, 443 (73%) set no upper age limit and 107 (18%) stop at 75 or younger; 39 take children under 18; 45 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →15 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 5 started in 2022.
Median enrollment 43 across the 15 interventional studies. Of the 8 that completed or were terminated, 4 (50%) have results posted.
3 of 15 have an industry lead sponsor. The 10 most frequent:
Corcept Therapeutics is the lead sponsor of 73 studies on the registry; 3 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 9 (28%) have results posted.
Corcept Therapeutics has 4 studies filed under Ovarian Neoplasms — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 15 studies testing Albumin-Bound Paclitaxel in Ovarian Neoplasms, from their registry updates:
The primary objectives of this study are to evaluate progression-free survival (PFS) by blinded independent central review (BICR) and overall survival (OS) (evaluated independently, as dual primary endpoints) in patients treated with intermittent regimen of relacorilant in combination with nab-paclitaxel compared with patients treated with nab-paclitaxel monotherapy.
As there are no currently approved therapies or effective standard of care for heavily pretreated patients with ovarian cancer who have exhausted single-agent chemotherapy and/or bevacizumab, the combination of intermittently administered relacorilant and nab-paclitaxel may demonstrate a substantial improvement without increased toxicity compared with nab-paclitaxel.
Patients will receive study treatment until confirmed progressive disease (PD) or unacceptable toxicity. All patients will be followed for the collection of study endpoints, inclusive of disease progression and survival.
The criteria were revised on the registry on Sep 25, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receive nab-paclitaxel 80 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle in combination with intermittent relacorilant (150 mg relacorilant once daily on the day before, the day of, and the day after nab-paclitaxel), administered orally under fed conditions. Relacorilant will not be administered on Cycle 1 Day -1.
Drug: Relacorilant 150 mg · Drug: Nab-paclitaxel 80 mg/m^2
Patients receive nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle.
Drug: Nab-paclitaxel 100 mg/m^2
Relacorilant is administered as capsules for oral dosing once daily on the day before, the day of, and the day after nab-paclitaxel administration.
Also known as: Lifyorli
Drug page: Albumin-Bound Paclitaxel
Nab-paclitaxel is administered as intravenous (IV) infusion over 30-40 minutes on Days 1, 8, and 15 of each 28-day cycle.
Drug page: Albumin-Bound Paclitaxel
Nab-paclitaxel is administered as IV infusion over 30-40 minutes on Days 1, 8, and 15 of each 28-day cycle.
Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)
PFS was assessed as the time from randomization until the time of first documented progressive disease (PD) or death due to any cause, whichever occurs first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or an unequivocal progression in a non-target lesion, or the appearance of new lesions.
Time frame: Up to 20 months
Overall Survival
Overall survival (OS) was assessed as the time from randomization to death by any cause. The data values are Kaplan-Meier estimates.
Time frame: Up to 32 months
PFS as Assessed by the Investigator
PFS was assessed as the time from randomization until the time of first documented progressive disease (PD) by RECIST v1.1, or death due to any cause, whichever occurs first.
Time frame: Up to 20 months
Objective Response as Assessed by the Investigator
Objective response was assessed as the proportion of patients with measurable disease at baseline who attained complete response (CR) or partial response (PR). Confirmation of the response was not required for this outcome measure per RECIST v1.1 criteria for randomized controlled clinical trials. Responses were assessed by imaging, using RECIST v1.1 criteria for target lesions: CR, Disappearance of all target lesions; PR, ≥30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: Up to 20 months
Best Overall Response as Assessed by the Investigator
Best overall response was assessed as the proportion of patients with at least 1 post Baseline scan who attained CR, PR, stable disease (SD), or PD as best response by RECIST v1.1.
Time frame: Up to 20 months
Duration of Confirmed Responses as Assessed by the Investigator
The median duration of response is presented for confirmed responses (CR or PR) per RECIST v1.1. Duration of response was from the first documented and confirmed response to the first objectively documented PD as assessed by the Investigator, or death due to any cause, whichever occurs first.
Time frame: From the time of confirmed CR or PR to the time of the first PD or death (Up to 18 months)
Clinical Benefit Rate at 24 Weeks as Assessed by BICR and the Investigator
Clinical benefit rate was assessed as the proportion of patients who attained CR, PR, or stable disease (SD) for 24 weeks per RECIST v1.1 as assessed by BICR and as assessed by the Investigator.
Time frame: 24 weeks
Cancer Antigen (CA)-125 Response
CA-125 response was assessed per Gynecologic Cancer Intergroup (GCIG) criteria defined as ≥50% reduction in CA-125 from a pretreatment sample and maintained for ≥28 days in patients with a pretreatment sample that is at least twice the upper limit of the reference range within 2 weeks before starting the treatment. In addition, patients who have a CA-125 response and whose CA-125 level fell to within the reference range were classified as CA-125 complete responders.
Time frame: Up to 24 months
Combined Overall Response Rate by RECIST v1.1 and CA-125 Defined by GCIG Criteria
Combined response was assessed as the proportion of patients with tumor response per RECIST v1.1 assessed by the investigator and for CA-125 response per GCIG criteria.
Time frame: Up to 15 months
Number of Patients With One or More Adverse Events
Time frame: Up to 22 months
Number of Patients Who Discontinued the Study Treatment Due to an Adverse Event
Time frame: Up to 25 months
A total of 498 patients were screened and 381 were enrolled into the study.
| Milestone | Relacorilant 150 mg With Nab-paclitaxel 80 mg/m^2 | Nab-paclitaxel 100 mg/m^2 |
|---|---|---|
| Started | 188 | 193 |
| Received study drug | 188 | 190 |
| Completed | 0 | 0 |
| Not completed | 188 | 193 |
| Withdrew: Death | 125 | 150 |
| Withdrew: Withdrawal by subject | 13 | 16 |
| Withdrew: Lost to follow-up | 0 | 2 |
| Withdrew: Discontinued study drug but completed long-term follow-up | 1 | 0 |
| Withdrew: Erroneous assignment of disease progression | 0 | 1 |
| Withdrew: Still on study at time of analysis | 49 | 24 |
PFS was assessed as the time from randomization until the time of first documented progressive disease (PD) or death due to any cause, whichever occurs first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or an unequivocal progression in a non-target lesion, or the appearance of new lesions.
| months | Relacorilant 150 mg With Nab-paclitaxel 80 mg/m^2 | Nab-paclitaxel 100 mg/m^2 |
|---|---|---|
| Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) | 6.54 (5.55 to 7.43) | 5.52 (3.94 to 5.88) |
Overall survival (OS) was assessed as the time from randomization to death by any cause. The data values are Kaplan-Meier estimates.
| months | Relacorilant 150 mg With Nab-paclitaxel 80 mg/m^2 | Nab-paclitaxel 100 mg/m^2 |
|---|---|---|
| Overall Survival | 15.97 (13.04 to 18.33) | 11.86 (10.02 to 13.80) |
PFS was assessed as the time from randomization until the time of first documented progressive disease (PD) by RECIST v1.1, or death due to any cause, whichever occurs first.
| months | Relacorilant 150 mg With Nab-paclitaxel 80 mg/m^2 | Nab-paclitaxel 100 mg/m^2 |
|---|---|---|
| PFS as Assessed by the Investigator | 5.39 (3.98 to 5.65) | 3.94 (3.71 to 5.32) |
Objective response was assessed as the proportion of patients with measurable disease at baseline who attained complete response (CR) or partial response (PR). Confirmation of the response was not required for this outcome measure per RECIST v1.1 criteria for randomized controlled clinical trials. Responses were assessed by imaging, using RECIST v1.1 criteria for target lesions: CR, Disappearance of all target lesions; PR, ≥30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
| Participants | Relacorilant 150 mg With Nab-paclitaxel 80 mg/m^2 | Nab-paclitaxel 100 mg/m^2 |
|---|---|---|
| Objective Response as Assessed by the Investigator | 69 | 58 |
Best overall response was assessed as the proportion of patients with at least 1 post Baseline scan who attained CR, PR, stable disease (SD), or PD as best response by RECIST v1.1.
| Participants | Relacorilant 150 mg With Nab-paclitaxel 80 mg/m^2 | Nab-paclitaxel 100 mg/m^2 |
|---|---|---|
| CR | 6 | 4 |
| PR | 63 | 54 |
| SD | 77 | 68 |
| PD | 32 | 52 |
The median duration of response is presented for confirmed responses (CR or PR) per RECIST v1.1. Duration of response was from the first documented and confirmed response to the first objectively documented PD as assessed by the Investigator, or death due to any cause, whichever occurs first.
| months | Relacorilant 150 mg With Nab-paclitaxel 80 mg/m^2 | Nab-paclitaxel 100 mg/m^2 |
|---|---|---|
| Duration of Confirmed Responses as Assessed by the Investigator | 5.55 (5.06 to 7.39) | 5.45 (3.78 to 7.46) |
Clinical benefit rate was assessed as the proportion of patients who attained CR, PR, or stable disease (SD) for 24 weeks per RECIST v1.1 as assessed by BICR and as assessed by the Investigator.
| Participants | Relacorilant 150 mg With Nab-paclitaxel 80 mg/m^2 | Nab-paclitaxel 100 mg/m^2 |
|---|---|---|
| Assessed by BICR | 92 | 76 |
| Assessed by the Investigator | 96 | 75 |
CA-125 response was assessed per Gynecologic Cancer Intergroup (GCIG) criteria defined as ≥50% reduction in CA-125 from a pretreatment sample and maintained for ≥28 days in patients with a pretreatment sample that is at least twice the upper limit of the reference range within 2 weeks before starting the treatment. In addition, patients who have a CA-125 response and whose CA-125 level fell to within the reference range were classified as CA-125 complete responders.
| Percentage of patients | Relacorilant 150 mg With Nab-paclitaxel 80 mg/m^2 | Nab-paclitaxel 100 mg/m^2 |
|---|---|---|
| Cancer Antigen (CA)-125 Response | 43.4 (35.2 to 51.9) | 37.4 (30.2 to 45.1) |
Combined response was assessed as the proportion of patients with tumor response per RECIST v1.1 assessed by the investigator and for CA-125 response per GCIG criteria.
| Participants | Relacorilant 150 mg With Nab-paclitaxel 80 mg/m^2 | Nab-paclitaxel 100 mg/m^2 |
|---|---|---|
| Combined Overall Response Rate by RECIST v1.1 and CA-125 Defined by GCIG Criteria | 95 | 75 |
| Participants | Relacorilant 150 mg With Nab-paclitaxel 80 mg/m^2 | Nab-paclitaxel 100 mg/m^2 |
|---|---|---|
| Number of Patients With One or More Adverse Events | 188 | 189 |
| Participants | Relacorilant 150 mg With Nab-paclitaxel 80 mg/m^2 | Nab-paclitaxel 100 mg/m^2 |
|---|---|---|
| Discontinued relacorilant | 19 | 0 |
| Discontinued nab-paclitaxel | 18 | 15 |
Collected over All-cause Mortality: up to 32 months; Adverse Events: up to 25 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Relacorilant 150 mg With Nab-paclitaxel 80 mg/m^2 | 129/188 (68.6%) | 66/188 (35.1%) | 183/188 (97.3%) |
| Nab-paclitaxel 100 mg/m^2 | 157/193 (81.3%) | 45/190 (23.7%) | 185/190 (97.4%) |
| Event | Relacorilant 150 mg With Nab-paclitaxel 80 mg/m^2 | Nab-paclitaxel 100 mg/m^2 |
|---|---|---|
| Intestinal obstructionGastrointestinal disorders | 9/188 | 9/190 |
| Small intestinal obstructionGastrointestinal disorders | 7/188 | 3/190 |
| PneumoniaInfections and infestations | 6/188 | 1/190 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 6/188 | 3/190 |
| AscitesGastrointestinal disorders | 5/188 | 3/190 |
| Febrile neutropeniaBlood and lymphatic system disorders | 4/188 | 1/190 |
| SubileusGastrointestinal disorders | 4/188 | 0/190 |
| NeutropeniaBlood and lymphatic system disorders | 3/188 | 0/190 |
| IleusGastrointestinal disorders | 3/188 | 2/190 |
| StomatitisGastrointestinal disorders | 3/188 | 0/190 |
| Event | Relacorilant 150 mg With Nab-paclitaxel 80 mg/m^2 | Nab-paclitaxel 100 mg/m^2 |
|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 115/188 | 106/190 |
| NauseaGastrointestinal disorders | 82/188 | 66/190 |
| NeutropeniaBlood and lymphatic system disorders | 75/188 | 65/190 |
| DiarrhoeaGastrointestinal disorders | 74/188 | 52/190 |
| AlopeciaSkin and subcutaneous tissue disorders | 72/188 | 59/190 |
| ConstipationGastrointestinal disorders | 62/188 | 51/190 |
| AstheniaGeneral disorders | 59/188 | 50/190 |
| Abdominal painGastrointestinal disorders | 55/188 | 54/190 |
| VomitingGastrointestinal disorders | 49/188 | 42/190 |
| FatigueGeneral disorders | 49/188 | 42/190 |
The Intent-to-Treat (ITT) population was all randomized patients, analyzed according to the randomized treatment arm.
| Age, Continuous(years) | Relacorilant 150 mg With Nab-paclitaxel 80 mg/m^2 | Nab-paclitaxel 100 mg/m^2 | Total |
|---|---|---|---|
| Mean | 61.5 ± 9.77 | 62.0 ± 9.55 | 61.8 ± 9.65 |
| Sex: Female, Male(Participants) | Relacorilant 150 mg With Nab-paclitaxel 80 mg/m^2 | Nab-paclitaxel 100 mg/m^2 | Total |
|---|---|---|---|
| Female | 188 | 193 | 381 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Relacorilant 150 mg With Nab-paclitaxel 80 mg/m^2 | Nab-paclitaxel 100 mg/m^2 | Total |
|---|---|---|---|
| Hispanic or Latino | 16 | 17 | 33 |
| Not Hispanic or Latino | 145 | 146 | 291 |
| Unknown or Not Reported | 27 | 30 | 57 |
| Race (NIH/OMB)(Participants) | Relacorilant 150 mg With Nab-paclitaxel 80 mg/m^2 | Nab-paclitaxel 100 mg/m^2 | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 22 | 26 | 48 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 2 | 5 |
| White | 136 | 135 | 271 |
| More than one race | 4 | 4 | 8 |
| Unknown or Not Reported | 23 | 26 | 49 |
| Primary Diagnosis(Participants) | Relacorilant 150 mg With Nab-paclitaxel 80 mg/m^2 | Nab-paclitaxel 100 mg/m^2 | Total |
|---|---|---|---|
| Ovarian cancer | 163 | 168 | 331 |
| Fallopian cancer | 21 | 14 | 35 |
| Primary peritoneal cancer | 4 | 11 | 15 |
Showing the first 100 of 116 sites across 14 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jun 2022 to primary completion in Mar 2025, 33 months.
Results were first posted in Sep 2026, 1 year 5 months after primary completion.
Of 73 industry-sponsored phase 3 interventional studies under Ovarian Neoplasms, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 72. This study's 33 months is below that.
Counting every sponsor, half of 125 studies reached it within 59 months; a quarter within 37 and three quarters within 89.
Completion moved once since we started tracking on Sep 25, 2026: Mar 2026 → Dec 2026, on Sep 25, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
Olawaiye AB, Gladieff L, O'Malley DM, Kim JW, Garbaos G, Salutari V, Gilbert L, Mileshkin L, Devaux A, Hopp E, Lee YJ, Oaknin A, Scaranti M, Kim BG, Colombo N,…PubMed 40473448 ↗; 1 more. 2 publications citing this study linked from PubMed
Olawaiye AB, Gladieff L, O'Malley DM, Kim JW, Garbaos G, Salutari V, Gilbert L, Mileshkin L, Devaux A, Hopp E, Lee YJ, Oaknin A, Scaranti M, Kim BG, Colombo N,…PubMed 40473448 ↗; 1 more. 2 publications citing this study linked from PubMed
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Relacorilant · Albumin-Bound Paclitaxel