Clinical trial • Phase II • Oncology
RELACORILANT for Gynecological cancers | Ovarian cancer | Endometrial cancer | Fallopian tube cancer | Peritoneal neoplasm
Phase II trial of RELACORILANT for Gynecological cancers | Ovarian cancer | Endometrial cancer | Fallopian tube cancer | Peritoneal neoplasm. open-label.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Gynecological cancers | Ovarian cancer | Endometrial cancer | Fallopian tube cancer | Peritoneal neoplasm
- Trial Stage
- Phase II
- Drug Modality
- Small molecule | Monoclonal antibody
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 17-01-2025
- First CTIS Authorization Date
- 12-05-2025
Trial design
open-label Phase II trial across 28 sites in France, Belgium, Spain and others.
- Open Label
- Yes
- Target Sample Size
- 171
Eligibility
Recruits 171 adults.
- Pregnancy Exclusion
- Negative pregnancy test for patients of childbearing potential
Inclusion criteria
- {"criterion_text":"- Arms A and B: • Histologic diagnosis of epithelial ovarian, primary peritoneal, or fallopian tube carcinoma\n- Arm A Only: Platinum-resistant disease\n- Arm B Only: Platinum-sensitive disease who had progression while receiving treatment with a poly(ADP-ribose) polymerase (PARP) inhibitor\n- Life expectancy of ≥3 months\n- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n- Able to swallow and retain oral medication\n- 1 to 3 lines of prior systemic anticancer therapy\n- Adequate organ function\n- Negative pregnancy test for patients of childbearing potential\n- Arm C: • Stage III or IV, recurrent, or metastatic endometrial cancer\n- Life expectancy of ≥3 months\n- ECOG performance status of 0 or 1\n- Able to swallow and retain oral medication\n- Prior treatment with a platinum agent and an approved anti-Programmed Cell Death Ligand 1 (PD[L]1) antibody\n- 1 to 2 lines of prior systemic anticancer therapy for endometrial cancer\n- Must consent to provide an available formalin-fixed paraffin-embedded (FFPE) tumor tissue block or recently cut sections\n- Adequate organ function\n- Negative pregnancy test for patients of childbearing potential"}
Exclusion criteria
- {"criterion_text":"- Arm A and B: • Arm A Only: Has progressed while receiving weekly paclitaxel or nab-paclitaxel\n- Prior enrollment in a clinical trial of relacorilant\n- Prior anticancer therapy related toxicities not resolved to grade ≤1\n- Any surgery within 4 weeks prior to enrollment\n- Wide-field radiation to more than 25% of marrow-bearing areas\n- Medical conditions requiring chronic or frequent treatment with corticosteroids\n- Concurrent treatment with mifepristone or other glucocorticoid receptor modulators\n- Peripheral neuropathy from any cause >Grade 1\n- Hypertension: ≥150 mm Hg systolic or ≥100 mm Hg diastolic\n- Uncontrolled condition(s) which, may confound the results of the trial or interfere with the patient’s safety or participation\n- Bowel obstruction ≤12 weeks prior to study entry\n- Ascites or pleural effusions requiring therapeutic paracentesis\n- Untreated or symptomatic central nervous system metastases\n- History of other malignancy within 3 years prior to enrollment\n- Has received a live vaccine within 30 days prior to the study start date\n- Arm C: • Has progressed while receiving weekly paclitaxel or nab-paclitaxel\n- Prior enrollment in a clinical trial of relacorilant\n- Prior anticancer therapy related toxicities not resolved to grade ≤1\n- Any surgery within 4 weeks prior to enrollment\n- Wide-field radiation to more than 25% of marrow-bearing areas\n- Medical conditions requiring chronic or frequent treatment with corticosteroids\n- Concurrent treatment with mifepristone or other glucocorticoid receptor modulators\n- Peripheral neuropathy from any cause >Grade 1\n- Uncontrolled condition(s) which, may confound the results of the trial or interfere with the patient’s safety or participation\n- Bowel obstruction ≤12 weeks prior to study entry\n- Ascites or pleural effusions requiring therapeutic paracentesis\n- History of other malignancy within 3 years prior to enrollment\n- Has received a live vaccine within 30 days prior to the study start date\n- Patients with central nervous system metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study."}
Endpoints
Primary endpoints
- {"endpoint_text":"- To evaluate PFS as the time from enrollment until first documented progressive disease (PD) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as determined by the Investigator, or death due to any cause, whichever occurs first.","definition_or_measurement_approach":"To evaluate PFS as the time from enrollment until first documented progressive disease (PD) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as determined by the Investigator, or death due to any cause, whichever occurs first."}
Secondary endpoints
- {"endpoint_text":"- ORR: To evaluate the proportion of patients with measurable disease at Baseline who attain complete response (CR) or partial response (PR) by RECIST version 1.1 •\t[Time Frame: Date of first dose until PD or death, up to 18 months]","definition_or_measurement_approach":"[Time Frame: Date of first dose until PD or death, up to 18 months]. Proportion of patients with measurable disease at baseline achieving CR or PR by RECIST v1.1."}
- {"endpoint_text":"- BOR: To evaluate the BOR by RECIST version 1.1 recorded from the date of enrollment until PD or death •\t[Time Frame: Date of first dose until PD or death, up to 18 months]","definition_or_measurement_approach":"[Time Frame: Date of first dose until PD or death, up to 18 months]. Best overall response per RECIST v1.1 recorded from enrollment until PD or death."}
- {"endpoint_text":"- DOR: To evaluate DOR as the time from the first CR or PR to first objectively documented PD or death, whichever comes first. •\t[Time Frame: Time of first objective response until PD or death, up to 18 months]","definition_or_measurement_approach":"[Time Frame: Time of first objective response until PD or death, up to 18 months]. Duration measured from first CR/PR to documented PD or death."}
- {"endpoint_text":"- CBR: To evaluate CBR as the proportion of patients who attain CR, PR, or stable disease (SD) at Week 24 as per RECIST version 1.1. •\t[Time Frame: Week 24]","definition_or_measurement_approach":"[Time Frame: Week 24]. Proportion of patients with CR, PR, or SD at Week 24 per RECIST v1.1."}
- {"endpoint_text":"- OS: To evaluate the probability of OS survival at 6, 12, and 18 months. •\t[Time Frame: Date of first dose up to 6, 12, and 18 months]","definition_or_measurement_approach":"[Time Frame: Date of first dose up to 6, 12, and 18 months]. Overall survival probability assessed at 6, 12 and 18 months from first dose."}
- {"endpoint_text":"- Number of patients with one or more adverse events •\t[Time Frame: Date of first dose up to 30 days after last dose]","definition_or_measurement_approach":"[Time Frame: Date of first dose up to 30 days after last dose]. Count of patients experiencing one or more adverse events."}
Recruitment
- Planned Sample Size
- 171
- Recruitment Window Months
- 25
- Consent Approach
- Informed consent obtained using L1_SIS and ICF subject information and informed consent form documents. ICF materials and related documents are available in multiple languages (English, French, Dutch, Italian, Spanish, Polish) and include separate pregnancy follow-up, newborn child data collection, and long-term follow-up ICFs. Consent is provided by participating adult patients (female subjects).
Geography
- Total Number Of Sites
- 28
- Total Number Of Participants
- 171
France
- Earliest CTIS Part Ii Submission Date
- 04-03-2025
- Latest Decision Or Authorization Date
- 14-04-2026
- Processing Time Days
- 406
- Number Of Sites
- 6
- Number Of Participants
- 13
Sites
- Site Name
- Hospices Civils De Lyon
- Department Name
- Oncologie Medicale
- Principal Investigator Name
- Marianne Lorcet
- Principal Investigator Email
- marianne.lorcet@chu-lyon.fr
- Contact Person Name
- Marianne Lorcet
- Contact Person Email
- marianne.lorcet@chu-lyon.fr
- Site Name
- Centre Oscar Lambret
- Principal Investigator Name
- Charlotte Bellier
- Principal Investigator Email
- c.bellier@o-lambret.fr
- Contact Person Name
- Charlotte Bellier
- Contact Person Email
- c.bellier@o-lambret.fr
- Site Name
- Oncopole Claudius Regaud
- Department Name
- Departement d’oncologie medicale
- Principal Investigator Name
- Laurence Gladieff
- Principal Investigator Email
- gladieff.laurence@iuct-oncopole.fr
- Contact Person Name
- Laurence Gladieff
- Contact Person Email
- gladieff.laurence@iuct-oncopole.fr
- Site Name
- Medipole De Nancy
- Principal Investigator Name
- Laurene Gavoille
- Principal Investigator Email
- l.gavoille@oncog.fr
- Contact Person Name
- Laurene Gavoille
- Contact Person Email
- l.gavoille@oncog.fr
- Site Name
- Centre Antoine Lacassagne
- Principal Investigator Name
- Philippe FOLLANA
- Principal Investigator Email
- philippe.follana@nice.unicancer.fr
- Contact Person Name
- Philippe FOLLANA
- Contact Person Email
- philippe.follana@nice.unicancer.fr
- Site Name
- Hopital Prive Des Cotes D'armor
- Principal Investigator Name
- Fanny DERQUIN
- Principal Investigator Email
- f.derquin@cario-sante.fr
- Contact Person Name
- Fanny DERQUIN
- Contact Person Email
- f.derquin@cario-sante.fr
Belgium
- Earliest CTIS Part Ii Submission Date
- 10-04-2025
- Latest Decision Or Authorization Date
- 22-01-2026
- Processing Time Days
- 287
- Number Of Sites
- 5
- Number Of Participants
- 15
Sites
- Site Name
- Grand Hopital De Charleroi
- Department Name
- Medical Oncology
- Principal Investigator Name
- Alix Devaux
- Principal Investigator Email
- Alix.devaux@ghdc.be
- Contact Person Name
- Alix Devaux
- Contact Person Email
- Alix.devaux@ghdc.be
- Site Name
- Onze-Lieve-Vrouwziekenhuis
- Department Name
- Medical Oncology
- Principal Investigator Name
- Greet Huygh
- Principal Investigator Email
- Greet.huygh@olvz-aalst.be
- Contact Person Name
- Greet Huygh
- Contact Person Email
- Greet.huygh@olvz-aalst.be
- Site Name
- Cliniques Universitaires Saint-Luc
- Department Name
- Medical Oncology
- Principal Investigator Name
- Jean-François Baurain
- Principal Investigator Email
- Jean-francois.baurain@saintlucuclouvain.be
- Contact Person Name
- Jean-François Baurain
- Contact Person Email
- Jean-francois.baurain@saintlucuclouvain.be
- Site Name
- Jessa Ziekenhuis
- Department Name
- Oncology
- Principal Investigator Name
- Eric Joosens
- Principal Investigator Email
- Eric.joosens@jessazh.be
- Contact Person Name
- Eric Joosens
- Contact Person Email
- Eric.joosens@jessazh.be
- Site Name
- UZ Leuven
- Department Name
- Gynecologic Oncology
- Principal Investigator Name
- TOON Van Gorp
- Principal Investigator Email
- Toon.vangorp@uzleuven.be
- Contact Person Name
- TOON Van Gorp
- Contact Person Email
- Toon.vangorp@uzleuven.be
Spain
- Earliest CTIS Part Ii Submission Date
- 06-03-2025
- Latest Decision Or Authorization Date
- 23-01-2026
- Processing Time Days
- 323
- Number Of Sites
- 5
- Number Of Participants
- 12
Sites
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Oncology
- Principal Investigator Name
- Ana Santaballa Bertrán
- Principal Investigator Email
- santaballa_ana@gva.es
- Contact Person Name
- Ana Santaballa Bertrán
- Contact Person Email
- santaballa_ana@gva.es
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- Oncology
- Principal Investigator Name
- Jose Perez-Fidalgo
- Principal Investigator Email
- japfidalgo@msn.com
- Contact Person Name
- Jose Perez-Fidalgo
- Contact Person Email
- japfidalgo@msn.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncology
- Principal Investigator Name
- Lorena Farinas
- Principal Investigator Email
- lfarinas@vhio.net
- Contact Person Name
- Lorena Farinas
- Contact Person Email
- lfarinas@vhio.net
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Oncology
- Principal Investigator Name
- Alfonso Cortes Salgado
- Principal Investigator Email
- acsalgado86@gmail.com
- Contact Person Name
- Alfonso Cortes Salgado
- Contact Person Email
- acsalgado86@gmail.com
- Site Name
- Institut Catala D'oncologia
- Department Name
- Oncology
- Principal Investigator Name
- Pau Guillen
- Principal Investigator Email
- pguillens@iconcologia.net
- Contact Person Name
- Pau Guillen
- Contact Person Email
- pguillens@iconcologia.net
Italy
- Earliest CTIS Part Ii Submission Date
- 07-04-2025
- Latest Decision Or Authorization Date
- 14-04-2026
- Processing Time Days
- 372
- Number Of Sites
- 7
- Number Of Participants
- 101
Sites
- Site Name
- Azienda Ospedaliera Ordine Mauriziano Di Torino
- Department Name
- Oncologia Medica
- Principal Investigator Name
- Giorgio Valabrega
- Principal Investigator Email
- giorgio.valabrega@unito.it
- Contact Person Name
- Giorgio Valabrega
- Contact Person Email
- giorgio.valabrega@unito.it
- Site Name
- Fondazione IRCCS Policlinico San Matteo
- Department Name
- Dip. Materno-infantile Ostetricia e Ginecologia
- Principal Investigator Name
- Chiara Cassani
- Principal Investigator Email
- ch.cassani@smatteo.pv.it
- Contact Person Name
- Chiara Cassani
- Contact Person Email
- ch.cassani@smatteo.pv.it
- Site Name
- Azienda Unita' Locale Socio Sanitaria N. 2 Marca Trevigiana
- Department Name
- Dip. Oncologia Medica
- Principal Investigator Name
- Grazia Artioli
- Principal Investigator Email
- grazia.artioli@aulss2.veneto.it
- Contact Person Name
- Grazia Artioli
- Contact Person Email
- grazia.artioli@aulss2.veneto.it
- Site Name
- Istituto Europeo Di Oncologia S.r.l.
- Department Name
- Dipartimento di Ginecologia Oncologica
- Principal Investigator Name
- Nicoletta Colombo
- Principal Investigator Email
- nicoletta.colombo@ieo.it
- Contact Person Name
- Nicoletta Colombo
- Contact Person Email
- nicoletta.colombo@ieo.it
- Site Name
- Humanitas Mirasole S.p.A.
- Department Name
- Ginecologia Oncologica
- Principal Investigator Name
- Domenica Lorusso
- Principal Investigator Email
- domenica.lorusso@hunimed.eu
- Contact Person Name
- Domenica Lorusso
- Contact Person Email
- domenica.lorusso@hunimed.eu
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- UOS Programmazione Ricerca Clinica
- Principal Investigator Name
- Vanda Salutari
- Principal Investigator Email
- vanda.salutari@policlinicogemelli.it
- Contact Person Name
- Vanda Salutari
- Contact Person Email
- vanda.salutari@policlinicogemelli.it
- Site Name
- Azienda Ospedaliera Per L'Emergenza Cannizzaro
- Department Name
- Dipartimento di Oncologia Medica
- Principal Investigator Name
- Giuseppa Scandurra
- Principal Investigator Email
- giusy.scandurra@gmail.com
- Contact Person Name
- Giuseppa Scandurra
- Contact Person Email
- giusy.scandurra@gmail.com
Germany
- Earliest CTIS Part Ii Submission Date
- 10-04-2025
- Latest Decision Or Authorization Date
- 06-02-2026
- Processing Time Days
- 302
- Number Of Sites
- 3
- Number Of Participants
- 17
Sites
- Site Name
- Universitaetsklinikum Aachen AöR
- Department Name
- Klinik für Gynäkologie und Geburtsmedizin
- Principal Investigator Name
- Philipp Meyer-Wilmes
- Principal Investigator Email
- phmeyer@ukaachen.de
- Contact Person Name
- Philipp Meyer-Wilmes
- Contact Person Email
- phmeyer@ukaachen.de
- Site Name
- Klinikverbund Allgaeu gGmbH
- Department Name
- Klinik für Frauenheilkunde und Geburtshilfe
- Principal Investigator Name
- Ricardo Felberbaum
- Principal Investigator Email
- ricardo.felberbaum@klinikverbund-allgaeu.de
- Contact Person Name
- Ricardo Felberbaum
- Contact Person Email
- ricardo.felberbaum@klinikverbund-allgaeu.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Gynäkologie
- Principal Investigator Name
- Jalid Sehouli
- Principal Investigator Email
- jalid.sehouli@charite.de
- Contact Person Name
- Jalid Sehouli
- Contact Person Email
- jalid.sehouli@charite.de
Poland
- Earliest CTIS Part Ii Submission Date
- 14-04-2025
- Latest Decision Or Authorization Date
- 07-04-2026
- Processing Time Days
- 358
- Number Of Sites
- 2
- Number Of Participants
- 13
Sites
- Site Name
- Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o.
- Department Name
- Siedleckie Centrum Onkologii, Oddział Onkologii Klinicznej i Radioterapii
- Principal Investigator Name
- Lubomir Bodnar
- Principal Investigator Email
- lbodnar@szpital.siedlce.pl
- Contact Person Name
- Lubomir Bodnar
- Contact Person Email
- lbodnar@szpital.siedlce.pl
- Site Name
- Szpitale Pomorskie Sp. z o.o.
- Department Name
- Oddział Onkologii i Radioterapii, Oddział Onkologii Klinicznej - Leczenie „Jednego Dnia“
- Principal Investigator Name
- Joanna Pikiel
- Principal Investigator Email
- joanna.pikiel@post.pl
- Contact Person Name
- Joanna Pikiel
- Contact Person Email
- joanna.pikiel@post.pl
Sponsor
Primary sponsor
- Full Name
- Corcept Therapeutics Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- WCG Clinical Inc.
- Responsibilities
- Central IRB Services
- Name
- Syneos Health Inc.
- Responsibilities
- Clinical operations/regulatory/safety (codes: 1,12,5,8 as listed in sponsorDuties)
- Name
- IQVIA Limited
- Responsibilities
- Central Laboratory
- Name
- Fortrea Inc.
- Responsibilities
- Pharmacovigilance services
Third parties
- {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Central IRB Services","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Sharp Corp.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Netherlands","full_name":"Manufacturing Packaging Farmaca (MPF) B.V.","duties_or_roles":"EU Qualified Person (QP) release","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"Codes: 1, 12, 5, 8","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"Pharmacovigilance services","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Scisafe Inc.","duties_or_roles":"long-term sample storage site","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Q Squared Solutions LLC","duties_or_roles":"Central Laboratory","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"France","full_name":"Asso De Recherche Cancers Gynecologiques","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Spain","full_name":"Taxi Travel Ticket S.L.","duties_or_roles":"patient travel arrangement in Spain","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Germany","full_name":"Ascopharm GmbH","duties_or_roles":"Patient expense reimbursement vendor for FRA and POL","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Central Laboratory","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"Trial master file repository","organisation_type":"Non-Pharmaceutical company"}
Investigational products
- Investigational Product Name
- CORT125134
- Active Substance
- RELACORILANT
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL USE
- Authorisation Status
- 1
- Orphan Designation
- Yes
- Maximum Dose
- 150 mg
- Investigational Product Name
- relacorilant
- Active Substance
- RELACORILANT
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL USE
- Authorisation Status
- 1
- Orphan Designation
- Yes
- Maximum Dose
- 150 mg
- Investigational Product Name
- PACLITAXEL ALBUMIN-BOUND
- Active Substance
- PACLITAXEL ALBUMIN-BOUND
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENIOUS INFUSION
- Route
- INTRAVENIOUS INFUSION
- Authorisation Status
- 2
- Maximum Dose
- 80 mg/m2
- Investigational Product Name
- BEVACIZUMAB
- Active Substance
- BEVACIZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- INTRAVENOUS INFUSION
- Authorisation Status
- 2
- Maximum Dose
- 10 mg/kg
- Combination Treatment
- Yes
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