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Recurrent Ovarian CancerPhase 2NCT03776812

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

A Phase 2 study testing Relacorilant and Nab-paclitaxel in people with Recurrent Ovarian Cancer and Recurrent Fallopian Tube Carcinoma, run by Corcept Therapeutics at 24 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Relacorilant and Nab-paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
178 participants
Where
24 sitesin 5 countries
Study dates
5 Apr 2019to 12 Jul 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed and dated Investigational Review Board/Independent Ethics Committee-approved informed consent form (ICF) prior to study-specific screening procedures.
  • Female patients aged ≥18 years old at time of consent
  • Histologic diagnosis of high grade serous or endometrioid epithelial ovarian, primary peritoneal, or fallopian tube cancer or ovarian carcinosarcoma. Clear cell, mucinous and borderline histologic subtypes are excluded.
  • Received at least 1 line of therapy with evidence of cancer progression within 6 months after the last dose of platinum-based therapy (ie, having a platinum-free interval of ≤6 months [platinum resistant]), or progressive disease during or immediately after primary platinum-therapy, (ie, platinum refractory). Patients with primary platinum resistance (progression within 6 months of the last dose of first-line platinum-containing chemotherapy) are considered eligible.
  • Notes: For the calculation of the platinum-free interval, cancer progression must be defined by clear evidence of progression, such as radiographic progression per RECIST v1.1. Calculating the platinum-free interval on the basis of increased Cancer Antigen (CA-125) is not allowed.
  • Measurable or non-measurable disease by RECIST v1.1:
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  • Previously irradiated lesions are not allowed as measurable disease, unless there is documented evidence of progression in the lesions.
  • To be eligible with non-measurable disease, patients must have evaluable disease with CA 125 at least twice the upper limit of reference range (of CA-125 ≥70 U/mL), along with radiographically evaluable disease by computerized tomography (CT)/magnetic resonance imaging (MRI).
  • Availability and consent to provide tumor tissue for biomarker assays (archival or recent biopsy).
  • No more than 4 prior chemotherapeutic or myelosuppressive regimens (not including maintenance therapy such as single-agent bevacizumab or poly (ADP-ribose) polymerase [PARP] inhibitors). Patients with platinum-refractory cancer cannot have had more than 2 prior lines of treatment for refractory disease.
  • Appropriate to treat with nab-paclitaxel, in the opinion of the Investigator.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  • Adequate organ and bone marrow function meeting the following criteria at the Screening Visit:
  • Absolute neutrophil count (ANC) ≥1,500 cells/mm^3.
  • Platelet count ≥100,000/mm^3.
  • Hemoglobin ≥9 g/dL.
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤2.5 × upper limit of normal (ULN) (or ≤5 × ULN in the context of liver metastasis).
  • Total bilirubin ≤1.5 × ULN.
  • Creatinine clearance ≥45 mL/min/1.73 m^2 (measured or estimated).
  • Albumin ≥3 g/dL (≥30 g/L) .
  • If patient has undergone surgery of the gastrointestinal or hepatobiliary tract, adequate absorption as evidenced by: albumin ≥3.0 g/dL, controlled pancreatic insufficiency (if present), and lack of malabsorption.
  • Able to swallow and retain oral medication and does not have uncontrolled emesis.
  • Able to comply with protocol requirements.
  • Negative pregnancy test for patients of childbearing potential. Patients of childbearing potential must use appropriate precautions to avoid pregnancy, defined as of non-childbearing potential (ie, postmenopausal or permanently sterilized) or using highly effective contraception with low user-dependency, for at least 3 months after the last dose of relacorilant, or per the duration indicated in the product label for nab-paclitaxel, whichever is latest. A woman is postmenopausal if it is more than 12 months since her last menstruation, without an alternative medical cause. Accepted methods of permanent sterilization methods are hysterectomy, bilateral salpingectomy, and/or bilateral oophorectomy. Accepted methods of highly effective contraception with low-user-dependency are:
  • An intrauterine device (IUD), provided that the subject has tolerated its use for at least 3 months before the first dose of study medication and undertakes not to have it removed for 1 month after the last dose.
  • Abstinence from heterosexual intercourse, when it is in line with the subject's preferred and usual lifestyle. Periodic abstinence and withdrawal are NOT acceptable.
  • Vasectomized partner provided that the partner is the sole sexual partner of the trial participant and that the vasectomized partner has received medical assessment of the surgical success.
  • Oral hormonal contraceptives are NOT permitted.

Who cannot join

  • Clinically relevant toxicity from prior systemic anticancer therapies or radiotherapy that in the opinion of the Investigator has not resolved to Grade 1 or less prior to randomization.
  • Any major surgery within 4 weeks prior to randomization. If subject received major surgery including (curative or palliative surgery), they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
  • Treatment with the following prior to randomization:
  • Concurrent treatment with other anticancer therapy including other chemotherapy, immunotherapy, radiotherapy, chemoembolization, targeted therapy, an investigational agent or the non-approved use of a drug or device within 28 days before the first dose of study drug.
  • Hormonal anticancer therapies within 7 days of the first dose of study drug.
  • Systemic, inhaled, or prescription strength topical corticosteroids within 21 days of the first dose of study drug. Short courses (≤5 days) for non-cancer-related reasons are allowed if clinically required (such as prophylaxis for CT).
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  • Received radiation to more than 25% of marrow-bearing areas.
  • Toxicities of prior therapies (except alopecia) that have not resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 ≤Grade 1.
  • Requirement for treatment with chronic or frequently used oral corticosteroids for medical conditions or illnesses (eg, rheumatoid arthritis, immunosuppression after organ transplantation).
  • History of severe hypersensitivity or severe reaction to either study drug.
  • Peripheral neuropathy from any cause >Grade 1.
  • Pregnant or lactating patients or patients expecting to conceive children within the projected duration of the trial, starting with the Screening Visit through at least 3 months after the last dose of relacorilant, or per the duration indicated in the product label for nab-paclitaxel, whichever is latest.
  • Human immunodeficiency virus or current chronic/active infection with hepatitis C virus or hepatitis B virus, including:
  • Patients with chronic or active hepatitis B as diagnosed by serologic tests are excluded from the study. In equivocal cases, hepatitis B or C polymerase chain reaction may be performed and must be negative for enrollment.
  • Patient has a clinically significant uncontrolled condition(s) or which in the opinion of the Investigator may confound the results of the trial or interfere with the patient's participation, including but not limited to:
  • Unstable angina pectoris, angioplasty, cardiac stenting, or myocardial infarction 6 months before study entry.
  • Uncontrolled hypertension (sustained systolic blood pressure >150 mmHg or diastolic pressure >100 mmHg despite optimal management). Patients will be considered eligible if hypertension is treated and controlled during Screening.
  • Active infection that requires parenteral antibiotics.
  • Bowel obstruction or gastric outlet obstruction.
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Untreated parenchymal central nervous system metastases.
  • Any other concurrent cancer or a history of another invasive malignancy within the last 3 years that has a likelihood of recurrence of >30% within the next 5 years. Adequately treated non-melanoma skin cancers or non-muscle invasive urothelial cancer or other tumors curatively treated with no evidence of disease are permissible.
  • Are taking a concomitant medication that is a strong CYP3A inhibitor or inducer, or that is a substrate of CYP3A with a narrow therapeutic window.
  • Concurrent treatment with mifepristone or other glucocorticoid receptor (GR) antagonists.
  • Concurrent treatment on other investigational treatment studies for the treatment of ovarian, fallopian tube, or primary peritoneal cancer.
  • Has received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.

Trial locations and contacts

24 sites in 5 countries.

24 sites in 5 countries

United States12 sites

  • Site Reference ID/Investigator #004

    Birmingham, Alabama, 35249

  • Site Reference ID/Investigator #106

    Boston, Massachusetts, 02215

  • Site Reference ID/Investigator #128

    Boston, Massachusetts, 02215

  • Site Reference ID/Investigator #135

    Charlottesville, Virginia, 22908

  • Site Reference ID/Investigator #001

    Chicago, Illinois, 60637

  • Site Reference ID/Investigator #032

    Denver, Colorado, 80045

  • Site Reference ID/Investigator #121

    Milwaukee, Wisconsin, 53226

  • Site Reference ID/Investigator #051

    New York, New York, 10065

  • Site Reference ID/Investigator #169

    New York, New York, 10065

  • Site Reference ID/Investigator #170

    New York, New York, 10065

  • Site Reference ID/Investigator #127

    Pittsburgh, Pennsylvania, 15213

  • Site Reference ID/Investigator #038

    Scottsdale, Arizona, 85258

Other trials in United States

Spain4 sites

  • Site Reference ID/Investigator #115

    Barcelona, 08035

  • Site Reference ID/Investigator #114

    Madrid, 28034

  • Site Reference ID/Investigator #116

    Madrid, 28034

  • Site Reference ID/Investigator #113

    Valencia, 46009

Other trials in Spain

Belgium3 sites

  • Site Reference ID/Investigator #109

    Brussels, 1200

  • Site Reference ID/Investigator #119

    Edegem, 2650

  • Site Reference ID/Investigator #108

    Leuven, 3000

Other trials in Belgium

Italy3 sites

  • Site Reference ID/Investigator #122

    Milan, 20141

  • Site Reference ID/Investigator #112

    Naples, 80131

  • Site Reference ID/Investigator #124

    Roma, 00168

Other trials in Italy

Canada2 sites

  • Site Reference ID/Investigator #096

    Montreal, Quebec, H2X 0A9

  • Site Reference ID/Investigator #117

    Toronto, Ontario, M4N 3M5

Other trials in Canada

About this study

Official title: A Phase 2, Randomized, Open-Label, 3-arm Study of Relacorilant in Combination With Nab-Paclitaxel for Patients With Recurrent Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

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.

Read the detailed description

Relacorilant is a small molecule antagonist of the glucocorticoid receptor (GR). The goals of this study are to evaluate the efficacy of relacorilant either administered daily (continuous) or on the day prior, the day of, and the day after chemotherapy (intermittent) in combination with nab-paclitaxel in the treatment of platinum-resistant ovarian, fallopian tube, or primary peritoneal cancers compared with nab-paclitaxel alone. The safety, pharmacokinetics (PK), and pharmacodynamic profile of relacorilant in combination with nab-paclitaxel will also be assessed.

Eligible patients will be randomized 1:1:1 to one of the following three treatment arms. Patient randomization will be stratified by treatment-free interval from most recent taxane (relapsed within 6 months vs >6 months) and presence of ascites (yes vs no).

  • Arm A (Continuous relacorilant): Relacorilant starting at 100 mg, administered orally, once daily every day in combination with nab-paclitaxel on Days 1, 8, and 15 of each 28-day cycle.
  • Arm B (Intermittent relacorilant): Relacorilant 150 mg, administered orally, on the day before (excluding Cycle 1, Day -1), the day of, and the day after nab-paclitaxel, in combination with nab-paclitaxel on Days 1, 8, and 15 of each 28-day cycle.
  • Arm C (Comparator): Nab-paclitaxel on Days 1, 8, and 15 of each 28-day cycle.

Patients will remain on study treatment until reaching a protocol-defined event of disease progression (PD), experiencing unmanageable toxicity, or until other treatment discontinuation criteria are met. All patients will be followed for progression, subsequent therapies, and survival in the long-term follow-up phase. Patients in Arm C who experience unequivocal PD per RECIST v1.1 will be given the opportunity to receive relacorilant in combination with nab-paclitaxel after discussion with the Medical Monitor (Crossover patients).

Being tested
Relacorilant, Nab-paclitaxel
Keywords
Glucocorticoid Receptor, Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, Nab-paclitaxel, Glucocorticoid Receptor Antagonist, Relacorilant
Medical subject headings
Ovarian Neoplasms, Fallopian Tube Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RelacorilantDrug

    Relacorilant is supplied as capsules for oral dosing.

  • Nab-paclitaxelDrug

    Also called Abraxane

    Nab-paclitaxel is administered as IV infusion over 30-40 minutes.

Study groups in NCT03776812
Study groupRoleWhat they receive
Arm A: Continuous Relacorilant DosingExperimentalPatients will receive relacorilant 100 mg (titrated up to 150 mg after Cycle 1 or 2) once daily in combination with nab-paclitaxel 80 mg/m^2, on Days 1, 8, and 15 of each 28-day cycle.
Receives: Drug: Relacorilant; Drug: Nab-paclitaxel
Arm B: Intermittent Relacorilant DosingExperimentalPatients will receive relacorilant 150 mg on the day before (excluding Cycle 1, Day -1), the day of, and the day after nab-paclitaxel, in combination with nab-paclitaxel 80 mg/m^2, on Days 1, 8, and 15 of each 28-day cycle.
Receives: Drug: Relacorilant; Drug: Nab-paclitaxel
Arm C: Nab-paclitaxel ComparatorActive comparatorPatients will receive nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15 of each 28-day cycle. Patients initially in Arm C who choose to cross over after disease progression will receive relacorilant 100 mg (titrated up to 150 mg) in combination with nab-paclitaxel 80 mg/m^2 on Days 1, 8, and 15 of each 28-day cycle after cross over.
Receives: Drug: Relacorilant; Drug: Nab-paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival (PFS)

    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.

    Measured: Baseline and up to 15 months

Secondary outcomes (11)

  1. Objective Response Rate (ORR)

    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).

    Measured: Baseline and up to 15 months

  2. Duration of Response (DOR)

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

    Measured: From first documented response up to 12 months

  3. Cancer Antigen 125 (CA-125) Response According to Gynecological Cancer Intergroup Criteria (GCIG)

    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.

    Measured: Baseline and up to 15 months

  4. Best Overall Response (BOR)

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

    Measured: Baseline and up to 15 months

  5. PFS Rate at 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.

    Measured: 6 and 12 months

  6. PFS in Patients Who Cross Over to Continuous Treatment at Time of Initial PD

    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.

    Measured: Crossover Baseline (Day 50) up to Day 272

  7. ORR in Patients Who Cross Over to Continuous Treatment at Time of Initial PD

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

    Measured: Crossover Baseline (Day 50) up to Day 272

  8. DOR in Patients Who Cross Over to Continuous Treatment at Time of Initial PD

    To assess the time from when the first objective response (CR or PR) in the crossover period to the first objectively documented subsequent PD, or death (whichever occurs first)

    Measured: From the time of objective response in the crossover period to the time of subsequent PD

  9. BOR in Patients Who Cross Over to Continuous Treatment at Time of Initial PD

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

    Measured: Crossover Baseline (Day 50) up to Day 272

  10. Overall Survival (OS)

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

    Measured: Up to 31 months

  11. Overall Response According to Combined RECIST v1.1 + GCIG Criteria

    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.

    Measured: Baseline and up to 15 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2018
  2. Study start5 Apr 2019
  3. Primary completion16 Mar 2021
  4. Study completion12 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
178 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03776812
Sponsor's protocol ID
CORT125134-552
Status last verified
Apr 2025
First submitted
13 Dec 2018
Last updated
7 Oct 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhou Y, Tong F, Jin B, Pan J, Ren N, Ren L, Xu Q. Relacorilant plus nab-paclitaxel for recurrent, platinum-resistant ovarian cancer: a cost-effectiveness study. J Gynecol Oncol. 2025 Jul;36(4):e63. doi: 10.3802/jgo.2025.36.e63. Epub 2025 Feb 20.

    PubMed 40051286

  • Colombo N, Van Gorp T, Matulonis UA, Oaknin A, Grisham RN, Fleming GF, Olawaiye AB, Nguyen DD, Greenstein AE, Custodio JM, Pashova HI, Tudor IC, Lorusso D. Relacorilant + Nab-Paclitaxel in Patients With Recurrent, Platinum-Resistant Ovarian Cancer: A Three-Arm, Randomized, Controlled, Open-Label Phase II Study. J Clin Oncol. 2023 Oct 20;41(30):4779-4789. doi: 10.1200/JCO.22.02624. Epub 2023 Jun 26.

    PubMed 37364223

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Relacorilant and Nab-paclitaxel in people with Recurrent Ovarian Cancer and Recurrent Fallopian Tube Carcinoma, run by Corcept Therapeutics at 24 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States, Spain, Belgium, Italy, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) (time frame: Baseline and up to 15 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03776812, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2025.

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