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

NCT03776812 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: CORT125134-552
• Study Type: interventional
• Target: 178
• Locations: 5 countries
• Sites: 24

Brief 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 patients treated with nab-paclitaxel alone.

Conditions

Recurrent Ovarian Cancer; Recurrent Fallopian Tube Carcinoma; Recurrent Primary Peritoneal Carcinoma

Keywords

Glucocorticoid Receptor; Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer; Nab-paclitaxel; Glucocorticoid Receptor Antagonist; Relacorilant

Outcome Measures

Primary Outcomes (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.

  Baseline and up to 15 months

Secondary Outcomes (11)

• Objective Response Rate (ORR)

  Baseline and up to 15 months

• Duration of Response (DOR)

  From first documented response up to 12 months

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

  Baseline and up to 15 months

• Best Overall Response (BOR)

  Baseline and up to 15 months

• PFS Rate at 6 and 12 Months

  6 and 12 months

Study Arms (3)

Arm A: Continuous Relacorilant Dosing

EXPERIMENTAL

Patients 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.

Drug: Relacorilant; Drug: Nab-paclitaxel

Arm B: Intermittent Relacorilant Dosing

EXPERIMENTAL

Patients 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.

Drug: Relacorilant; Drug: Nab-paclitaxel

Arm C: Nab-paclitaxel Comparator

ACTIVE COMPARATOR

Patients 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.

Drug: Relacorilant; Drug: Nab-paclitaxel

Interventions

Relacorilant DRUG

Relacorilant is supplied as capsules for oral dosing.

Arm A: Continuous Relacorilant Dosing; Arm B: Intermittent Relacorilant Dosing; Arm C: Nab-paclitaxel Comparator

Nab-paclitaxel DRUG

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

Also known as: Abraxane

Arm A: Continuous Relacorilant Dosing; Arm B: Intermittent Relacorilant Dosing; Arm C: Nab-paclitaxel Comparator

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only patients with recurrent ovarian, primary peritoneal, or fallopian tube cancer will be considered for this study
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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).
• 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:

Sponsors & Collaborators

• Corcept Therapeutics: lead

Study Sites (24)

Site Reference ID/Investigator #004

Birmingham, Alabama, 35249, United States

Location

Site Reference ID/Investigator #038

Scottsdale, Arizona, 85258, United States

Location

Site Reference ID/Investigator #032

Denver, Colorado, 80045, United States

Location

Site Reference ID/Investigator #001

Chicago, Illinois, 60637, United States

Location

Site Reference ID/Investigator #106

Boston, Massachusetts, 02215, United States

Location

Site Reference ID/Investigator #128

Boston, Massachusetts, 02215, United States

Location

Site Reference ID/Investigator #051

New York, New York, 10065, United States

Location

Site Reference ID/Investigator #169

New York, New York, 10065, United States

Location

Site Reference ID/Investigator #170

New York, New York, 10065, United States

Location

Site Reference ID/Investigator #127

Pittsburgh, Pennsylvania, 15213, United States

Location

Site Reference ID/Investigator #135

Charlottesville, Virginia, 22908, United States

Location

Site Reference ID/Investigator #121

Milwaukee, Wisconsin, 53226, United States

Location

Site Reference ID/Investigator #109

Brussels, 1200, Belgium

Location

Site Reference ID/Investigator #119

Edegem, 2650, Belgium

Location

Site Reference ID/Investigator #108

Leuven, 3000, Belgium

Location

Site Reference ID/Investigator #117

Toronto, Ontario, M4N 3M5, Canada

Location

Site Reference ID/Investigator #096

Montreal, Quebec, H2X 0A9, Canada

Location

Site Reference ID/Investigator #122

Milan, 20141, Italy

Location

Site Reference ID/Investigator #112

Napoli, 80131, Italy

Location

Site Reference ID/Investigator #124

Roma, 00168, Italy

Location

Site Reference ID/Investigator #115

Barcelona, 08035, Spain

Location

Site Reference ID/Investigator #114

Madrid, 28034, Spain

Location

Site Reference ID/Investigator #116

Madrid, 28034, Spain

Location

Site Reference ID/Investigator #113

Valencia, 46009, Spain

Location

Related Publications (2)

• 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.

  PMID: 40051286 DERIVED

• 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.

  PMID: 37364223 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms

Interventions

relacorilant; 130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Medical Director
• Organization: Corcept Therapeutics

info@corcept.com

650-327-3270

Study Officials

• Sachin Pai, MD

  Corcept Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2018
• First Posted: December 17, 2018
• Study Start: April 5, 2019
• Primary Completion: March 16, 2021
• Study Completion: July 12, 2023
• Last Updated: October 7, 2025
• Results First Posted: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (4); CA (2); US (12); IT (3); BE (3)