Fact CheckerSign in

NCT05257408Active, not recruitingPhase 3

Relacorilant in Combination With Nab-Paclitaxel in Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer

A Phase 3 Study of Relacorilant in Combination With Nab-Paclitaxel Versus Nab-Paclitaxel Monotherapy in Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer (ROSELLA)

Source: ClinicalTrials.gov · Last updated 25 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
381 (actual)
First submitted
4 Feb 2022
Start date
29 Jun 2022
Primary completion date
31 Mar 2025
Lead sponsor
Corcept Therapeutics
NCT number
NCT05257408
EU CT number
2024-514080-25-00
EudraCT number
2022-000662-18

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 381
  • From 29 Jun 2022 to the primary completion date, 31 Mar 2025
  • 119 sites in 14 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Has clinically relevant toxicity from prior systemic anticancer therapies or radiotherapy that has not resolved to ≤Grade 1 prior to randomization.
  • Has had any major surgery within 4 weeks prior to randomization.
  • Has not received prior bevacizumab treatment.
  • Has been treated with the following prior to randomization: chemotherapy, immunotherapy, investigational agent treatments for disease under study within 28 days before first dose of study drug, radiotherapy not completed at least 2 weeks prior to first dose of study drug, hormonal anticancer therapies within 7 days of first dose of study drug, and systemic, inhaled, or prescription strength topical corticosteroids within 21 days of first dose of study drug.
  • Has received wide-field radiation to more than 25% of marrow-bearing areas.
  • Has toxicities of prior therapies that have not resolved by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0, ≤Grade 1.
  • Requires treatment with chronic or frequently used oral corticosteroids for medical conditions or illnesses.
  • Is receiving concurrent treatment with mifepristone or other glucocorticoid receptor (GR) modulators.
  • Is taking a concomitant medication that is a strong cytochrome P450 (CYP)3A inhibitor or strong CYP3A inducer, or that is a substrate of CYP3A with a narrow therapeutic window.
  • 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 prior to the study start date.

Other illness

  • Has primary platinum-refractory disease, defined as disease that did not respond to or has progressed ≤1 month of the last dose of first-line platinum-containing chemotherapy.
  • Has a history of severe hypersensitivity or severe reaction to any of the study drugs.
  • Has clinically significant uncontrolled condition(s) or condition which, in the opinion of the Investigator, may confound the results of the trial or interfere with the patient's safety or participation.
  • Has current chronic/active infection with human immunodeficiency virus or current chronic/active infection with hepatitis C virus or hepatitis B virus.
  • Patients with a history of other malignancy within 3 years prior to randomization.

Other

  • Has low-grade endometrioid, clear cell, mucinous, or sarcomatous histology, or mixed tumors containing any of these histologies, or low-grade or borderline ovarian tumor.
  • Has 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 1 month after the last dose of relacorilant, or 6 months after the last dose of nab-paclitaxel whichever is the longest.
  • Has any untreated or symptomatic central nervous system (CNS) metastases.

Who the study is looking for

  • Signed and dated Institutional Review Board/Independent Ethics Committee-approved informed consent form prior to study-specific screening procedures.
  • Confirmed histologic diagnosis of high-grade (Grade 3) serous, epithelial ovarian, primary peritoneal, or fallopian tube carcinoma.
  • Patients must have platinum-resistant disease (defined as RECIST v1.1 defined progression \<6 months from completion of a platinum-containing therapy).
  • Must consent to provide archival tumor-tissue block or slides. Patients may consent to an optional tumor biopsy if archival tumor is unavailable.
  • Has a life expectancy of ≥3 months.
  • At least one lesion that meets the definition of measurable disease by RECIST v1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  • Able to comply with protocol requirements.
  • Able to swallow and retain oral medication and does not have uncontrolled emesis.
  • Received at least 1 but ≤3 lines of prior systemic anticancer therapy and at least 1 prior line of platinum therapy and prior treatment with bevacizumab is required.
  • Has adequate organ function meeting the following laboratory-test criteria: Absolute neutrophil count (ANC) ≥1500 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 context of liver metastases, Total bilirubin ≤1.5 × ULN, and Albumin ≥3 g/dL, and creatinine clearance \>40 mL/min/1.73 m\^2 (measured or estimated).
  • Negative pregnancy test for patients of childbearing potential; patients of childbearing potential must agree to use highly effective contraceptive method(s); hormonal contraceptives are not allowed.
  • Coronavirus disease (COVID-19) approved vaccines are accepted concomitant medications when recommended by the Investigator.

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (119)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
-
Coordinator of this site? Confirm its status
CABAArgentinaUnknown status
-
Coordinator of this site? Confirm its status
Ciudad Autonoma de Buenos AireArgentinaUnknown status
-
Coordinator of this site? Confirm its status
CórdobaArgentinaUnknown status
-
Coordinator of this site? Confirm its status
CórdobaArgentinaUnknown status
-
Coordinator of this site? Confirm its status
CórdobaArgentinaUnknown status
-
Coordinator of this site? Confirm its status
MendozaArgentinaUnknown status
-
Coordinator of this site? Confirm its status
RosarioArgentinaUnknown status
-
Coordinator of this site? Confirm its status
RosarioArgentinaUnknown status
-
Coordinator of this site? Confirm its status
BenowaAustraliaUnknown status
-
Coordinator of this site? Confirm its status
MelbourneAustraliaUnknown status
-
Coordinator of this site? Confirm its status
MelbourneAustraliaUnknown status
-
Coordinator of this site? Confirm its status
St LeonardsAustraliaUnknown status
Onze-Lieve-Vrouwziekenhuis
Coordinator of this site? Confirm its status
AalstBelgiumCompleted
Grand Hopital de Charleroi
Coordinator of this site? Confirm its status
CharleroiBelgiumCompleted
JESSA Ziekenhuis
Coordinator of this site? Confirm its status
HasseltBelgiumCompleted
UZ Leuven
Coordinator of this site? Confirm its status
LeuvenBelgiumCompleted
Cliniques Universitaires Saint-Luc
Coordinator of this site? Confirm its status
Sint-Lambrechts-WoluweBelgiumCompleted
-
Coordinator of this site? Confirm its status
Belo HorizonteBrazilUnknown status
-
Coordinator of this site? Confirm its status
BrasíliaBrazilUnknown status
-
Coordinator of this site? Confirm its status
FortalezaBrazilUnknown status
-
Coordinator of this site? Confirm its status
NatalBrazilUnknown status
-
Coordinator of this site? Confirm its status
Porto AlegreBrazilUnknown status
-
Coordinator of this site? Confirm its status
Rio de JaneiroBrazilUnknown status
-
Coordinator of this site? Confirm its status
SalvadorBrazilUnknown status
-
Coordinator of this site? Confirm its status
São PauloBrazilUnknown status
-
Coordinator of this site? Confirm its status
São PauloBrazilUnknown status
-
Coordinator of this site? Confirm its status
São PauloBrazilUnknown status
-
Coordinator of this site? Confirm its status
São PauloBrazilUnknown status
-
Coordinator of this site? Confirm its status
São PauloBrazilUnknown status
-
Coordinator of this site? Confirm its status
MontrealCanadaUnknown status
-
Coordinator of this site? Confirm its status
TorontoCanadaUnknown status
Institut Catala d'Oncologia
Coordinator of this site? Confirm its status
BadalonaSpainCompleted
Hospital Universitari Vall d'Hebron
Coordinator of this site? Confirm its status
BarcelonaSpainCompleted
Hospital Universitario Donostia
Coordinator of this site? Confirm its status
DonostiaSpainCompleted
Hospital Universitario Y Politecnico La Fe
Coordinator of this site? Confirm its status
ValenciaSpainCompleted
Centre Oscar Lambret
Coordinator of this site? Confirm its status
LilleFranceCompleted
Institut Regional Du Cancer De Montpellier
Coordinator of this site? Confirm its status
Montpellier Cedex 5FranceCompleted
Medipole De Nancy
Coordinator of this site? Confirm its status
NancyFranceCompleted
Centre Antoine Lacassagne
Coordinator of this site? Confirm its status
Nice Cedex 2FranceCompleted
Assistance Publique Hopitaux de Paris
Coordinator of this site? Confirm its status
ParisFranceCompleted
Hospices Civils de Lyon
Coordinator of this site? Confirm its status
Pierre-BéniteFranceCompleted
Hôpital Privé des Côtes d'Armor
Coordinator of this site? Confirm its status
PlérinFranceCompleted
Oncopole Claudius Regaud
Coordinator of this site? Confirm its status
Toulouse Cedex 9FranceCompleted
-
Coordinator of this site? Confirm its status
BrightonUnited KingdomUnknown status
-
Coordinator of this site? Confirm its status
CheltenhamUnited KingdomUnknown status
-
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
-
Coordinator of this site? Confirm its status
ManchesterUnited KingdomUnknown status
-
Coordinator of this site? Confirm its status
NorthwoodUnited KingdomUnknown status
-
Coordinator of this site? Confirm its status
TauntonUnited KingdomUnknown status
Orszagos Onkologiai Intezet
Coordinator of this site? Confirm its status
Budapest XIIHungaryCompleted
University of Debrecen
Coordinator of this site? Confirm its status
DebrecenHungaryCompleted
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Coordinator of this site? Confirm its status
GyőrHungaryCompleted
-
Coordinator of this site? Confirm its status
HaifaIsraelUnknown status
-
Coordinator of this site? Confirm its status
JerusalemIsraelUnknown status
-
Coordinator of this site? Confirm its status
Tel AvivIsraelUnknown status
Azienda Ospedaliera per l Emergenza Cannizzaro
Coordinator of this site? Confirm its status
CataniaItalyCompleted
Ospedale Mater Salutis Di Legnago
Coordinator of this site? Confirm its status
LegnagoItalyCompleted
Istituto Europeo di Oncologia s.r.l
Coordinator of this site? Confirm its status
MilanItalyCompleted
Fondazione IRCCS Policlinico San Matteo
Coordinator of this site? Confirm its status
PaviaItalyCompleted
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Coordinator of this site? Confirm its status
RomeItalyCompleted
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Coordinator of this site? Confirm its status
RomeItalyCompleted
Azienda Unita' Locale Socio Sanitaria N. 2 Marca Trevigiana
Coordinator of this site? Confirm its status
TrevisoItalyCompleted
Azienda Ospedaliera Ordine Mauriziano di Torino
Coordinator of this site? Confirm its status
TurinItalyCompleted
Azienda Sanitaria Universitaria Friuli Centrale
Coordinator of this site? Confirm its status
UdineItalyCompleted
-
Coordinator of this site? Confirm its status
Gyeonggi-doSouth KoreaUnknown status
-
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
-
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
-
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
-
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
-
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
-
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
-
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Szpitale Pomorskie Sp z o o
Coordinator of this site? Confirm its status
GdyniaPolandCompleted
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o.
Coordinator of this site? Confirm its status
SiedlcePolandCompleted
Uniwersytecki Szpital Kliniczny Nr 2 PUM w Szczecinie
Coordinator of this site? Confirm its status
SzczecinPolandCompleted
-
Coordinator of this site? Confirm its status
AlbuquerqueUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
AtlantaUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
AtlantaUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
AuroraUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
AustinUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
BedfordUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
BethlehemUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
BostonUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
CincinnatiUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
CincinnatiUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
EvanstonUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
FlushingUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
Fort WorthUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
GainesvilleUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
GermantownUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
HinsdaleUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
IndianapolisUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
IrvineUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
La JollaUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
LouisvilleUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
Miami BeachUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
MilwaukeeUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
NashvilleUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
New BrunswickUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
NorfolkUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
Overland ParkUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
Overland ParkUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
Palo AltoUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
PhoenixUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
PittsburghUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
PortlandUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
PortlandUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
PortlandUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
Rapid CityUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
RichmondUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
San AntonioUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
San FranciscoUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
San FranciscoUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
SavannahUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
SolvangUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
The WoodlandsUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
TucsonUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
UrbanaUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
WestonUnited StatesUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.