Clinical trial • Phase III • Oncology

RELACORILANT for Platinum-resistant high-grade epithelial ovarian cancer | Primary peritoneal cancer | Fallopian tube cancer

Phase III trial of RELACORILANT for Platinum-resistant high-grade epithelial ovarian cancer | Primary peritoneal cancer | Fallopian tube cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Platinum-resistant high-grade epithelial ovarian cancer | Primary peritoneal cancer | Fallopian tube cancer
Trial Stage
Phase III
Drug Modality
Small molecule
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
10-07-2024
First CTIS Authorization Date
31-07-2024

Trial design

Randomised, open-label, arm a (experimental): relacorilant 150 mg administered orally under fed conditions, once daily for 3 consecutive days on the day before (excluding cycle 1 day -1), the day of, and the day after nab-paclitaxel infusion, in combination with nab-paclitaxel 80 mg/m2 iv administered on days 1, 8, and 15 of each 28-day cycle. arm b (comparator/monotherapy): nab-paclitaxel 100 mg/m2 iv administered on days 1, 8, 15 of each 28-day cycle.-controlled Phase III trial in Belgium, Italy, France and others.

Randomised
Yes
Open Label
Yes
Comparator
Arm A (experimental): relacorilant 150 mg administered orally under fed conditions, once daily for 3 consecutive days on the day before (excluding Cycle 1 Day -1), the day of, and the day after nab-paclitaxel infusion, in combination with nab-paclitaxel 80 mg/m2 IV administered on Days 1, 8, and 15 of each 28-day cycle. Arm B (comparator/monotherapy): nab-paclitaxel 100 mg/m2 IV administered on Days 1, 8, 15 of each 28-day cycle.
Target Sample Size
176

Eligibility

Recruits 176 No vulnerable populations selected. Trial enrols adult female patients aged ≥18 years; informed consent must be a signed and dated IRB/IEC-approved informed consent form prior to study-specific screening. No assent or minor consent procedures are applicable..

Pregnancy Exclusion
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 6 months after the last dose of study treatment.
Vulnerable Population
No vulnerable populations selected. Trial enrols adult female patients aged ≥18 years; informed consent must be a signed and dated IRB/IEC-approved informed consent form prior to study-specific screening. No assent or minor consent procedures are applicable.

Inclusion criteria

  • {"criterion_text":"- Signed and dated Institutional Review Board/Independent Ethics Committee-approved informed consent form prior to study-specific Screening procedures.\n- Must consent to provide archival tumor-tissue block or slides, if available. Patients may consent to an optional tumor biopsy if archival tumor-tissue is unavailable.\n- Has a life expectancy of ≥3 months.\n- At least one lesion that meets the definition of measurable disease by RECIST v.1.1 (previously irradiated lesions not allowed as measurable disease unless there is documented evidence of progression in the lesions).\n- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n- Able to comply with protocol requirements.\n- Able to swallow and retain oral medication and does not have uncontrolled emesis.\n- Received at least 1 but ≤ 3 lines of prior systemic anticancer therapy (See Protocol for the guidance in counting the number of prior lines of therapy) with documented progressive disease or intolerance to the most recent therapy. At least 1 prior line of platinum therapy is required and prior treatment with bevacizumab is required.\n- Has adequate organ function meeting the protocol-defined laboratory test criteria.\n- 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.\n- COVID-19 approved vaccines (or vaccines with regulatory health authority's emergency use authorization / conditional marketing authorization) are accepted concomitant medications when recommended by the Investigator. Exceptions may apply should the Investigator and the Medical Monitor determine that the vaccine will interfere with the objectives of the study.\n- Female patients aged ≥18 years old at time of consent.\n- Confirmed histologic diagnosis of high-grade (Grade 3) serious, epithelial ovarian, primary peritoneal, or fallopian tube carcinoma (highgrade endometroid epithelial or carcinosarcoma with ≥30% epithelial component are eligible)\n- Patients must have platinum-resistant disease (defined as progression < 6 months (+7 days) from completion of a platinum-containing therapy)."}

Exclusion criteria

  • {"criterion_text":"- Has clinically relevant and reversible toxicity from prior systemic anticancer therapies or radiotherapy that has not resolved to ≤Grade 1 prior to randomization.\n- Has a history of severe hypersensitivity or severe reaction to any of the study drugs.\n- Is receiving concurrent treatment with mifepristone or other GR modulators.\n- Has peripheral neuropathy from any cause > Grade 1.\n- 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 6 months after the last dose of study treatment.\n- Has clinically significant uncontrolled condition(s) which, in the opinion of the Investigator, may confound the results of the trial or interfere with the patient's safety or participation.\n- Has current active (chronic/acute) infection with Human immunodeficiency virus, or hepatitis C virus or hepatitis B virus.\n- Has any untreated or symptomatic central nervous system (CNS) metastases.\n- Patients with a history of other malignancy within 3 years prior to randomization.\n- Is taking a prohibited concomitant medication listed in protocol (some of the prohibited concomitant medications listed may require a washout period prior to the first dose of study drug).\n- Concurrent treatment on other investigational treatment studies for ovarian, fallopian-tube, or primary peritoneal cancer.\n- Has had any major surgery within 4 weeks prior to randomization. If patient received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting the study treatment.\n- Has received a live vaccine within 30 days prior to the study start date.\n- Has low-grade serious or endometrioid histology other than epithelial, or clear cell, or mucinous, or sarcomatous with less than 30% epithelial histology component, or mixed tumors containing any of these histologies, or borderline ovarian tumor.\n- Has primary platinum-refractory disease, defined as disease that did not respond to, or has progressed during or within ≤ 1 month from completion of a platinum-containing chemotherapy in first-line treatment (measured from the date of the last dose of platinum).\n- Has not received prior bevacizumab treatment.\n- Has been treated with the following prior to randomization: − Chemotherapy, immunotherapy, investigational agent etc. treatments for disease under study within 5 times of half-life of the prior therapy, or 28 days if 5 times the half-life of the prior therapy is longer than 28 days, before the 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. − Systemic, inhaled, or prescription strength topical corticosteroids within a period equivalent to 5 times the half-life of the corticosteroid used prior to first dose of study drug.\n- Has received wide-field radiation to more than 25% of marrowbearing areas.\n- Has toxicities of prior therapies that are reversible and have not resolved the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0, ≤Grade 1.\n- Requires treatment with chronic or frequently used oral corticosteroids for medical conditions or illnesses (e.g., rheumatoid arthritis, immunosuppression after organ transplantation)."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- PFS: Time from randomization until first documented progressive disease (PD) by RECIST v1.1 per BICR, or death due to any cause, whichever occurs first","definition_or_measurement_approach":"PFS assessed by Blinded Independent Central Review (BICR) using RECIST v1.1; measured as time from randomization to first documented PD by RECIST v1.1 per BICR or death from any cause."}
  • {"endpoint_text":"- OS: Time from randomization to death by any cause.","definition_or_measurement_approach":"Overall survival measured as time from randomization to death from any cause."}

Secondary endpoints

  • {"endpoint_text":"- PFS (Investigators): Time from randomization until PD or death whichever occurred first as assessed by Investigator using RECIST v1.1.","definition_or_measurement_approach":"Investigator-assessed PFS measured by RECIST v1.1 as time from randomization to PD or death."}
  • {"endpoint_text":"- ORR: Proportion of patients with measurable disease at Baseline who attain complete response (CR) or partial response (PR) by RECIST v1.1.","definition_or_measurement_approach":"ORR assessed per RECIST v1.1 among patients with measurable disease at baseline; proportion achieving CR or PR."}
  • {"endpoint_text":"- BoR: Recorded from the date of randomization until PD/recurrence (or death).","definition_or_measurement_approach":"Best Overall Response recorded from randomization until PD/recurrence or death, per RECIST v1.1."}
  • {"endpoint_text":"- DoR: Time from the first objective response (CR or PR) to first objectively documented PD or death (whichever occurs first).","definition_or_measurement_approach":"Duration of Response measured from first documented CR or PR to first objectively documented PD or death."}
  • {"endpoint_text":"- CBR at 24 weeks: proportion of patients who attain CR, PR, or stable disease (SD) for 24 weeks as per RECIST v1.1.","definition_or_measurement_approach":"Clinical Benefit Rate at 24 weeks assessed per RECIST v1.1; proportion with CR, PR, or SD maintained for 24 weeks."}
  • {"endpoint_text":"- CA-125 response will be assessed per GCIG criteria","definition_or_measurement_approach":"CA-125 response evaluated according to Gynecologic Cancer InterGroup (GCIG) criteria (Rustin 2011) as specified in protocol."}
  • {"endpoint_text":"- Combined response according to RECIST v1.1 + GCIG criteria. Responses will be reported separately and combined for RECIST v1.1 and CA-125/GCIG criteria.","definition_or_measurement_approach":"A combined-response endpoint based on RECIST v1.1 and GCIG criteria; responses reported separately and as a combined RECIST+CA-125 (GCIG) endpoint."}

Other endpoints

  • {"endpoint_text":"- Patient-Reported Outcomes and Quality of Life Biomarkers (e.g., EORTC QLQ-C30, EORTC QLQ-OV28, EQ-5D-5L)","definition_or_measurement_approach":"PROs and QoL assessed using validated instruments listed in protocol (EORTC QLQ-C30, QLQ-OV28, EQ-5D-5L); measurement schedule per protocol (patient-completed questionnaires at specified visits)."}

Recruitment

Planned Sample Size
176
Recruitment Window Months
37
Consent Approach
Signed and dated IRB/IEC-approved informed consent form required prior to study-specific screening procedures. Adult patients (female ≥18 years) provide consent. Optional consents available (e.g., optional tumor biopsy, genetic testing as per country-specific ICFs). Subject information and informed consent forms available in multiple country/language versions (documents listed for PL, HUN, ES, IT, FR, BE-EN/FR/NL, and main English versions). Pregnancy-specific participant information and pregnancy ICFs are provided where applicable.

Geography

Total Number Of Sites
32
Total Number Of Participants
205

Belgium

Earliest CTIS Part Ii Submission Date
22-06-2024
Latest Decision Or Authorization Date
17-04-2026
Processing Time Days
664
Number Of Sites
5
Number Of Participants
21

Sites

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
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
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
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
Cliniques Universitaires Saint-Luc
Department Name
Medical Oncology
Principal Investigator Name
Jean-François Baurain
Contact Person Name
Jean-François Baurain

Italy

Earliest CTIS Part Ii Submission Date
22-06-2024
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
667
Number Of Sites
9
Number Of Participants
106

Sites

Site Name
Azienda Unita' Locale Socio Sanitaria N. 2 Marca Trevigiana
Department Name
U.O. Oncologia Medica
Principal Investigator Name
Grazia Artioli
Principal Investigator Email
grazia.artioli@aulss2.veneto.it
Contact Person Name
Grazia Artioli
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Dipartimento 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
Azienda Ospedaliera Ordine Mauriziano Di Torino
Department Name
S.C.D.U. Oncologia
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
Azienda Ospedaliera Per L'Emergenza Cannizzaro
Department Name
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
Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
SC 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
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
UOC Ginecologia Oncologica
Principal Investigator Name
Vanda Salutari
Principal Investigator Email
vanda.salutari@policlinicogemelli.it
Contact Person Name
Vanda Salutari
Site Name
Ospedale Mater Salutis Di Legnago
Department Name
UOC Oncologia Medica
Principal Investigator Name
Filippo Greco
Principal Investigator Email
filippo.greco@aulss9.veneto.it
Contact Person Name
Filippo Greco
Contact Person Email
filippo.greco@aulss9.veneto.it
Site Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department Name
U.O.C. Ginecologia Chirurgica ed Oncologica
Principal Investigator Name
Innocenza Palaia
Principal Investigator Email
innocenza.palaia@uniroma1.it
Contact Person Name
Innocenza Palaia
Contact Person Email
innocenza.palaia@uniroma1.it
Site Name
Azienda Sanitaria Universitaria Friuli Centrale
Department Name
Dipartimento di Oncologia
Principal Investigator Name
Claudia Andreetta
Principal Investigator Email
claudia.andreetta@asufc.sanita.fvg.it
Contact Person Name
Claudia Andreetta

France

Earliest CTIS Part Ii Submission Date
22-06-2024
Latest Decision Or Authorization Date
17-04-2026
Processing Time Days
664
Number Of Sites
8
Number Of Participants
49

Sites

Site Name
Assistance Publique Hopitaux De Paris
Department Name
Service d'oncologie medicale
Principal Investigator Name
Jacques Medioni
Principal Investigator Email
jacques.medioni@aphp.fr
Contact Person Name
Jacques Medioni
Contact Person Email
jacques.medioni@aphp.fr
Site Name
Centre Antoine Lacassagne
Principal Investigator Name
Philippe Follana
Principal Investigator Email
philippe.follana@nice.unicancer.fr
Contact Person Name
Philippe Follana
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
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
Hospices Civils De Lyon
Department Name
Oncologie Medicale
Principal Investigator Name
Benoit You
Principal Investigator Email
benoit.you@chu-lyon.fr
Contact Person Name
Benoit You
Contact Person Email
benoit.you@chu-lyon.fr
Site Name
Institut Regional Du Cancer De Montpellier
Principal Investigator Name
Stanislas Quesada
Principal Investigator Email
stanislas.quesada@icm.unicancer.fr
Contact Person Name
Stanislas Quesada
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

Hungary

Earliest CTIS Part Ii Submission Date
22-06-2024
Latest Decision Or Authorization Date
27-06-2025
Processing Time Days
370
Number Of Sites
3
Number Of Participants
6

Sites

Site Name
University Of Debrecen
Principal Investigator Name
Robert Poka
Principal Investigator Email
pokar@med.unideb.hu
Contact Person Name
Robert Poka
Contact Person Email
pokar@med.unideb.hu
Site Name
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Department Name
Oncoradiology
Principal Investigator Name
Kofi Agyemang-Prempeh
Principal Investigator Email
kagyemangprempeh54@gmail.com
Contact Person Name
Kofi Agyemang-Prempeh
Contact Person Email
kagyemangprempeh54@gmail.com
Site Name
Orszagos Onkologiai Intezet
Principal Investigator Name
Andrea Bagameri
Principal Investigator Email
bagameristudy@gmail.com
Contact Person Name
Andrea Bagameri
Contact Person Email
bagameristudy@gmail.com

Poland

Earliest CTIS Part Ii Submission Date
22-06-2024
Latest Decision Or Authorization Date
07-08-2024
Processing Time Days
46
Number Of Sites
3
Number Of Participants
2

Sites

Site Name
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o.
Department Name
Siedleckie Centrum Onkologii, Oddzial Onkologii Klinicznej i Radioterapii
Principal Investigator Name
Lubomir Bodnar
Principal Investigator Email
lubomirbodnar.lb@gmail.com
Contact Person Name
Lubomir Bodnar
Contact Person Email
lubomirbodnar.lb@gmail.com
Site Name
Szpitale Pomorskie Sp. z o.o.
Department Name
Szpital Morski im. PCK, Oddzial Onkologii i Radioterapii, Onkologia Kliniczna
Principal Investigator Name
Joanna Pikiel
Principal Investigator Email
joanna.pikiel@post.pl
Contact Person Name
Joanna Pikiel
Contact Person Email
joanna.pikiel@post.pl
Site Name
Uniwersytecki Szpital Kliniczny Nr 2 Pum W Szczecinie
Department Name
Kinika Ginekologii Operacyjnej i Onkologii Ginekologicznej Doroslych i Dziewczat
Principal Investigator Name
Anita Chudecka-Glaz
Principal Investigator Email
anitagl@poczta.onet.pl
Contact Person Name
Anita Chudecka-Glaz
Contact Person Email
anitagl@poczta.onet.pl

Spain

Earliest CTIS Part Ii Submission Date
22-06-2024
Latest Decision Or Authorization Date
28-04-2026
Processing Time Days
675
Number Of Sites
4
Number Of Participants
21

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 Universitari Vall D Hebron
Department Name
Oncology
Principal Investigator Name
Lorena Fariñas Madrid
Principal Investigator Email
lfarinas@vhio.net
Contact Person Name
Lorena Fariñas Madrid
Contact Person Email
lfarinas@vhio.net
Site Name
Hospital Universitario Donostia
Department Name
Oncology
Principal Investigator Name
Cristina Churruca Galaz
Principal Investigator Email
cristinamaria.churricagalaz@osakidetza.eus
Contact Person Name
Cristina Churruca Galaz
Site Name
Institut Catala D'oncologia
Department Name
Oncology
Principal Investigator Name
Pau Guillen Sentis
Principal Investigator Email
pguillens@iconcologia.net
Contact Person Name
Pau Guillen Sentis
Contact Person Email
pguillens@iconcologia.net

Sponsor

Primary sponsor

Full Name
Corcept Therapeutics Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Syneos Health UK Limited
Responsibilities
Study Management
Name
Fortrea Inc.
Responsibilities
Pharmacovigilance services
Name
WCG Clinical Inc.
Responsibilities
Central IRB Services
Name
Suvoda LLC
Responsibilities
sponsorDuties code: 3 (qualityassurance/data management vendor role indicated)

Third parties

  • {"country":"United States","full_name":"Precision For Medicine Inc.","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Quest Diagnostics Nichols Institute Inc.","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Rules Based Medicine Inc.","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"Long term storage facility","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Neogenomics Laboratories Inc.","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"Pharmacovigilance services; sponsorDuties code: 8","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Discovery Life Sciences LLC","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Central IRB Services","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Q Squared Solutions LLC","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Imaging Endpoints II LLC","duties_or_roles":"Medical imaging","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Drug Development Solutions Limited","duties_or_roles":"Quantitative bioanalysis","organisation_type":"Pharmaceutical company"}
  • {"country":"Hungary","full_name":"Oximio Hungary Kft.","duties_or_roles":"Importer of Record (IoR); Ancillary Supplies;Packaging, labelling, depot, storage, distribution;Importer of Record (IoR)","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Ascopharm GmbH","duties_or_roles":"Fees Reimbursement","organisation_type":"Pharmaceutical company"}
  • {"country":"Spain","full_name":"Taxi Travel Ticket S.L.","duties_or_roles":"Patient Reimbursement","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Syneos Health UK Limited","duties_or_roles":"Study Management","organisation_type":"Pharmaceutical company"}
  • {"country":"Italy","full_name":"Humanitas Mirasole S.p.A.","duties_or_roles":"site identification within ENGOT cooperative groups","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"sponsorDuties codes: [3]","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Iqvia Laboratories Limited","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name
relacorilant (CORT125134)
Active Substance
RELACORILANT
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
prodAuthStatus: 1
Orphan Designation
Yes
Starting Dose
150 mg
Dose Levels
150 mg
Frequency
Once daily for 3 consecutive days around nab-paclitaxel infusion (the day before [excluding Cycle 1 Day -1], the day of, and the day after infusion)
Maximum Dose
150 mg (maxDailyDoseAmount)
Investigational Product Name
Abraxane (nab-paclitaxel; paclitaxel albumin-bound)
Active Substance
PACLITAXEL ALBUMIN-BOUND
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Marketing authorisation present (marketingAuthNumber: EU/1/07/428/001); prodAuthStatus: 2
Starting Dose
80 mg/m2 IV (combination arm) and 100 mg/m2 IV (monotherapy arm)
Dose Levels
80 mg/m2; 100 mg/m2
Frequency
Days 1, 8, and 15 of each 28-day cycle
Maximum Dose
100 mg/m2 (maxDailyDoseAmount)
Combination Treatment
Yes

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