Clinical trial • Phase III • Oncology

OPEVESOSTAT TOSILATE for Metastatic castration-resistant prostate cancer

Phase III trial of OPEVESOSTAT TOSILATE for Metastatic castration-resistant prostate cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Metastatic castration-resistant prostate cancer
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
10-11-2023
First CTIS Authorization Date
18-03-2024

Trial design

Randomised, open-label, comparator arms: abiraterone acetate (tablet) — listed with max daily amount 1000 mg (administered orally) often given with prednisone/prednisolone (prednisone acetate/prednisone/prednisolone products listed, max daily dose 10 mg); enzalutamide (capsule) — listed with max daily amount 160 mg (administered orally).-controlled Phase III trial in Finland, Austria, Spain and others.

Randomised
Yes
Open Label
Yes
Comparator
Comparator arms: Abiraterone acetate (tablet) — listed with max daily amount 1000 mg (administered orally) often given with prednisone/prednisolone (prednisone acetate/prednisone/prednisolone products listed, max daily dose 10 mg); Enzalutamide (capsule) — listed with max daily amount 160 mg (administered orally).
Biomarker Stratified
True, AR LBD mutation (strata: AR LBD mutation-positive | AR LBD mutation-negative)
Target Sample Size
851

Eligibility

Recruits 851 No vulnerable populations selected. Study population is adult male participants with mCRPC. Informed consent is collected from each participant (country-specific main consent forms and optional consents for limited screening, genetic testing, and data privacy/GDPR). No assent processes for minors are indicated..

Vulnerable Population
No vulnerable populations selected. Study population is adult male participants with mCRPC. Informed consent is collected from each participant (country-specific main consent forms and optional consents for limited screening, genetic testing, and data privacy/GDPR). No assent processes for minors are indicated.

Inclusion criteria

  • {"criterion_text":"- Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology"}
  • {"criterion_text":"- Has provided tumor tissue from a fresh core or excisional biopsy from soft tissue not previously irradiated"}
  • {"criterion_text":"- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)"}
  • {"criterion_text":"- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days of randomization"}
  • {"criterion_text":"- Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before randomization."}
  • {"criterion_text":"- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at Screening."}
  • {"criterion_text":"- Has had prior treatment with poly (ADP-ribose) polymerase inhibitor (PARPi) or were deemed ineligible to receive treatment by the investigator or have refused PARPi treatment"}
  • {"criterion_text":"- Has received prior 177Lu-prostate-specific membrane antigen (PSMA)-617 or were deemed ineligible to receive 177Lu-PSMA-617 treatment by the investigator or refused 177Lu-PSMA-617 treatment"}
  • {"criterion_text":"- Participants who have not received cabazitaxel can be enrolled if they are ineligible for cabazitaxel treatment as determined by the investigator or have refused treatment"}
  • {"criterion_text":"- Has prostate cancer progression while on androgen deprivation therapy (or post bilateral orchiectomy) within 6 months before Screening"}
  • {"criterion_text":"- If participant received first generation anti-androgen therapy before screening, the participant has evidence of disease progression >4 weeks since the last flutamide treatment and >6 weeks since the last bicalutamide or nilutamide treatment"}
  • {"criterion_text":"- Has current evidence of metastatic disease documented by either bone lesions on bone scan and/or soft tissue disease by computed tomography/magnetic resonance imaging (CT/MRI)"}
  • {"criterion_text":"- Has disease that progressed during or after treatment with 1 novel hormonal agent (NHA)"}
  • {"criterion_text":"- Has received 1 but no more than 2 taxane-based chemotherapy regimens for metastatic castration-resistant prostate cancer (mCRPC) and has had progressive disease (PD) during or after treatment"}
  • {"criterion_text":"- Has ongoing androgen deprivation with serum testosterone <50 ng/dL (<1.7 nM)"}
  • {"criterion_text":"- Participants receiving bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on stable doses for ≥ 4 weeks before the date of randomization"}
  • {"criterion_text":"- If capable of producing sperm, participant must agree to the following during the study treatment period and for at least 7 days after the last dose of MK-5684, for at least 30 days after the last dose of abiraterone acetate, and for at least 3 months after the last dose of enzalutamide: EITHER be abstinent OR must agree to use male condom."}

Exclusion criteria

  • {"criterion_text":"- Has a gastrointestinal disorder that might affect absorption"}
  • {"criterion_text":"- Has undergone major surgery, including local prostate intervention (except prostate biopsy), within 28 days before the date of randomization, and has not recovered from the toxicities and/or complications"}
  • {"criterion_text":"- Participants who have not adequately recovered from major surgery or have ongoing surgical complications"}
  • {"criterion_text":"- Has used herbal or medicinal products that may have hormonal anti-prostate cancer activity and/or are known to decrease prostate-specific Antigen (PSA) (eg, saw palmetto, megesterol acetate) within 4 weeks before the date of randomization"}
  • {"criterion_text":"- Has received radium-223 or lutetium-177 within 4 weeks before the date of randomization, or has not recovered to Grade ≤1 or baseline from AEs due to radium-223 or lutetium-177 administered more than 4 weeks before the date of randomization"}
  • {"criterion_text":"- Is currently being treated with cytochrome 450-inducing antiepileptic drugs for seizures"}
  • {"criterion_text":"- Has received treatment with 5-αreductase inhibitors (eg, finasteride or dutasteride), estrogens, or cyproterone within 4 weeks before the date of randomization"}
  • {"criterion_text":"- Use of aldosterone antagonist (eg, spironolactone, eplerenone) and phenytoin within 4 weeks before the start of the study intervention"}
  • {"criterion_text":"- Participants on an unstable dose of thyroid hormone therapy within 6 months before the start of the study intervention"}
  • {"criterion_text":"- Has received colony-stimulating factors within 28 days before the date of randomization"}
  • {"criterion_text":"- Has received a whole blood transfusion in the last 120 days before the date of randomization. Packed red blood cells and platelet transfusions are acceptable if not given within 28 days of the date of randomization."}
  • {"criterion_text":"- Unable to swallow capsules/tablets"}
  • {"criterion_text":"- Has received prior targeted small molecule therapy or NHA treatment within 4 weeks before the first dose of study intervention as follows: enzalutamide or apalutamide within 3 weeks or abiraterone acetate + prednisone or darolutamide within 2 weeks"}
  • {"criterion_text":"- Received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention"}
  • {"criterion_text":"- Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids"}
  • {"criterion_text":"- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention"}
  • {"criterion_text":"- Has a “superscan” bone scan"}
  • {"criterion_text":"- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication"}
  • {"criterion_text":"- Known additional malignancy that is progressing or has required active treatment within the past 3 years"}
  • {"criterion_text":"- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis"}
  • {"criterion_text":"- Has an active autoimmune disease that has required systemic treatment in past 2 years"}
  • {"criterion_text":"- Has an active infection requiring systemic therapy"}
  • {"criterion_text":"- History of pituitary dysfunction"}
  • {"criterion_text":"- Has concurrent active HBV or known active HCV infection"}
  • {"criterion_text":"- Has a history of long QTc syndrome"}
  • {"criterion_text":"- Has any of the following at Screening Visit: hypotension (systolic blood pressure [BP] <110 mm Hg) or uncontrolled hypertension (systolic BP ≥160 mm Hg or diastolic BP ≥90 mm Hg, in 2 out of 3 recordings with optimized antihypertensive therapy)"}
  • {"criterion_text":"- Systemic use of the following medications within 2 weeks before the first dose of study intervention: strong CYP3A4 inducers (eg, avasimibe,carbamazepine, lumacaftor, phenobarbital, rifampicin, rifapentine, or St John's Wort); P-gp inhibitors (eg, erythromycin, clarithromycin,rifampicin, ketoconazole, itraconazole, posaconazole, artesunate-pyronaridine, ritonavir, indinavir, nelfi navir, atazanavir, glecaprevir-pibrentasvir,simeprevir, ledipasvir-sofosbuvir, verapamil, diltiazem, dronedarone, propafenone, quinidine, cyclosporine, valspodar, or milk thistle [Silybummarianum])"}
  • {"criterion_text":"- Poorly controlled diabetes mellitus"}
  • {"criterion_text":"- Clinically significant abnormal serum potassium or sodium level"}
  • {"criterion_text":"- Has a history of active or unstable cardio/cerebro-vascular disease, including thromboembolic events"}
  • {"criterion_text":"- Has a history of seizure within 6 months of providing documented informed consent or any condition that may predispose to seizures within 12 months before the date of randomization"}
  • {"criterion_text":"- Has a history of clinically significant ventricular arrhythmias"}
  • {"criterion_text":"- Has received an anticancer monoclonal antibody (mAb) within 4 weeks before the date of randomization, or has not recovered from adverse events (AEs) due to mAbs administered more than 4 weeks before the date of randomization"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Overall Survival (OS) in Androgen Receptor Ligand Binding Domain (AR LBD) mutation-positive participants","definition_or_measurement_approach":""}
  • {"endpoint_text":"- OS in AR LBD mutation-negative participants","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Radiographic Progression-free Survival (rPFS) Per Prostate Cancer Working Group-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review in AR LBD mutation-positive participants","definition_or_measurement_approach":"rPFS per PCWG-modified RECIST 1.1 as assessed by Blinded Independent Central Review (BICR)"}
  • {"endpoint_text":"- rPFS Per Prostate Cancer Working Group-modified RECIST 1.1 as Assessed by Blinded Independent Central Review in AR LBD mutation-negative participants","definition_or_measurement_approach":"rPFS per PCWG-modified RECIST 1.1 as assessed by Blinded Independent Central Review (BICR)"}
  • {"endpoint_text":"- Time to Initiation of the First Subsequent Anti-Cancer Therapy or Death (TFST)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Objective Response (OR) Per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review","definition_or_measurement_approach":"Objective Response per PCWG-modified RECIST 1.1 as assessed by Blinded Independent Central Review"}
  • {"endpoint_text":"- Duration of Response (DOR) Per PCWG-modified RECIST 1.1 as Assessed by Blinded Independent Central Review","definition_or_measurement_approach":"DOR per PCWG-modified RECIST 1.1 as assessed by Blinded Independent Central Review"}
  • {"endpoint_text":"- Time to Pain Progression (TTPP) as Assessed by Brief Pain Inventory-Short Form (BPI-SF) Item 3 (\"Worst Pain in 24 Hours\") and Opiate Analgesic Use (Analgesic Quantification Algorithm [AQA] Score)","definition_or_measurement_approach":"TTPP assessed using BPI-SF Item 3 (\"Worst Pain in 24 Hours\") and opiate analgesic use quantified by AQA score"}
  • {"endpoint_text":"- Time to Prostate-specific Antigen (PSA) Progression","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Time to First Symptomatic Skeletal-related Event (SSRE)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Number of Participants Who Experience an Adverse Event","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Number of Participants Who Discontinue Study Treatment Due to an Adverse Event","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
851
Recruitment Window Months
66
Consent Approach
Informed consent is obtained from each adult participant. Country-specific main consent forms (L1_ICF_Main consent) and optional consent modules (limited screening consent, genetic consent, GDPR/data privacy, optional items such as ClinCard) are used. Consent documents are available in country-specific languages and English (examples in Czech, German, Swedish, Finnish, English, Spanish, French, Polish, Italian, Dutch, Norwegian, Hungarian, Danish). No assent for minors is indicated; participants provide their own consent.

Geography

Total Number Of Sites
69
Total Number Of Participants
851

Finland

Earliest CTIS Part Ii Submission Date
20-02-2024
Latest Decision Or Authorization Date
10-02-2026
Processing Time Days
721
Number Of Sites
3
Number Of Participants
15

Sites

Site Name
Tampere University Hospital
Department Name
Department of Oncology
Contact Person Name
Mikko Moisander
Contact Person Email
mikko.moisander@pirha.fi
Site Name
Kuopio University Hospital
Department Name
Department of Oncology
Contact Person Name
Okko Kääriäinen
Site Name
Turku University Hospital
Department Name
Department of Oncology
Contact Person Name
Saana Virtanen
Contact Person Email
saana.maaria.virtanen@varha.fi

Austria

Earliest CTIS Part Ii Submission Date
12-03-2024
Latest Decision Or Authorization Date
16-02-2026
Processing Time Days
706
Number Of Sites
3
Number Of Participants
18

Sites

Site Name
Medical University Of Graz
Department Name
Department of Internal Medicine / Division of Oncology
Contact Person Name
Thomas Bauernhofer
Site Name
Klinikum Wels-Grieskirchen GmbH
Department Name
Department of Urology
Contact Person Name
Clemens Wiesinger
Site Name
Ordensklinikum Linz GmbH
Department Name
Department of Urology
Contact Person Name
Ferdinand Luger

Spain

Earliest CTIS Part Ii Submission Date
21-02-2024
Latest Decision Or Authorization Date
13-02-2026
Processing Time Days
723
Number Of Sites
7
Number Of Participants
50

Sites

Site Name
Hospital De Jerez De La Frontera
Department Name
Urology Department
Contact Person Name
Rocio Saiz Marenco
Contact Person Email
rociosaizm@gmail.com
Site Name
Hospital Universitario Lucus Augusti
Department Name
Oncology Department
Contact Person Name
Sergio Vázquez Estevez
Site Name
Complejo Hospitalario Universitario De Ourense
Department Name
Oncology Department
Contact Person Name
Ovidio Fernández Calvo
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Oncology Department
Contact Person Name
Teresa Alonso Gordoa
Contact Person Email
talonsogordoa@gmail.com
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncology Department
Contact Person Name
Enrique González Billalabeitia
Site Name
Fundacion Instituto Valenciano De Oncologia
Department Name
Oncology Department
Contact Person Name
Maria José Juan Fita
Contact Person Email
mjjuan@fivo.org
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Oncology Department
Contact Person Name
Begoña Pérez Valderrama

Poland

Earliest CTIS Part Ii Submission Date
16-02-2024
Latest Decision Or Authorization Date
16-02-2026
Processing Time Days
731
Number Of Sites
7
Number Of Participants
55

Sites

Site Name
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach
Department Name
Klinika Onkologii Klinicznej Ośrodek Chemioterapii Dziennej
Contact Person Name
Dariusz Kucharczyk
Site Name
Zachodniopomorskie Centrum Onkologii
Department Name
Ośrodek Badań Klinicznych
Contact Person Name
Katarzyna Hetman
Contact Person Email
szpital@onkologia.szczecin.pl
Site Name
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
Department Name
Oddział Onkologii Klinicznej z Pododdziałem Chemioterapii Jednodniowej
Contact Person Name
Mariusz Kwiatkowski
Contact Person Email
sekretariat.odch@swk.med.pl
Site Name
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Department Name
Ambulatorium Chemioterapii
Contact Person Name
Bogdan Zurawski
Site Name
Regionalny Szpital Specjalistyczny Im. Dr. Wladyslawa Bieganskiego
Department Name
Oddział Onkologii Klinicznej
Contact Person Name
Urszula Sadowska
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
Contact Person Name
Lubomir Bodnar
Contact Person Email
bbk@szpital.siedlce.pl
Site Name
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy (duplicate entry if present)
Department Name
Ambulatorium Chemioterapii
Contact Person Name
Bogdan Zurawski

Italy

Earliest CTIS Part Ii Submission Date
29-01-2024
Latest Decision Or Authorization Date
12-02-2026
Processing Time Days
745
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
Struttura Complessa Oncologia Medica 1
Contact Person Name
Giuseppe Procopio
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Oncologia Medica
Contact Person Name
Andrea Necchi
Contact Person Email
necchi.andrea@hsr.it
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
Oncologia Medica
Contact Person Name
Giuseppe Schepisi
Contact Person Email
giuseppe.schepisi@irst.emr.it

Czechia

Earliest CTIS Part Ii Submission Date
20-02-2024
Latest Decision Or Authorization Date
10-02-2026
Processing Time Days
721
Number Of Sites
4
Number Of Participants
25

Sites

Site Name
University Hospital Olomouc
Department Name
Onkologická klinika
Contact Person Name
Hana Študentová
Contact Person Email
hana.studentova@fnol.cz
Site Name
Fakultni Nemocnice V Motole
Department Name
Onkologicka klinika 2. LF UK a FN v Motole
Contact Person Name
Tomáš Büchler
Contact Person Email
tomas.buchler@fnmotol.cz
Site Name
Masarykuv Onkologicky Ustav
Department Name
Klinika komplexní onkologické péče
Contact Person Name
Jiří Navrátil
Contact Person Email
jnavratil@mou.cz
Site Name
Fakultni Nemocnice Ostrava
Department Name
Klinika onkologická
Contact Person Name
Zuzana Zděblová Čermáková

Sweden

Earliest CTIS Part Ii Submission Date
23-02-2024
Latest Decision Or Authorization Date
11-02-2026
Processing Time Days
719
Number Of Sites
3
Number Of Participants
18

Sites

Site Name
Uppsala University Hospital
Department Name
Department of Oncology
Contact Person Name
Ingrida Verbiene
Contact Person Email
ingrida.verbiene@akademiska.se
Site Name
Sahlgrenska University Hospital-Vastra Gotalandsregionen
Department Name
KPE Verksamhetsområde Onkologi
Contact Person Name
Jon Kindblom
Contact Person Email
jon.kindblom@vgregion.se
Site Name
Karolinska University Hospital
Department Name
Department of Oncology
Contact Person Name
Enrique Castellanos
Contact Person Email
enrique.castellanos@sll.se

Norway

Earliest CTIS Part Ii Submission Date
20-02-2024
Latest Decision Or Authorization Date
10-02-2026
Processing Time Days
721
Number Of Sites
3
Number Of Participants
20

Sites

Site Name
Akershus University Hospital
Department Name
Department of Oncology
Contact Person Name
Mohsan Syed
Contact Person Email
mohsan.ali.syed@ahus.no
Site Name
Sykehuset Oestfold HF Kalnes
Department Name
Department of Oncology
Contact Person Name
Øyvind Tennøe
Contact Person Email
Oyvind.Krohn.Tennoe@so-hf.no
Site Name
St. Olavs Hospital HF
Department Name
Cancer Clinic
Contact Person Name
Torgrim Tandstad
Contact Person Email
Torgrim.Tandstad@stolav.no

Germany

Earliest CTIS Part Ii Submission Date
24-11-2023
Latest Decision Or Authorization Date
12-02-2026
Processing Time Days
811
Number Of Sites
8
Number Of Participants
35

Sites

Site Name
HELIOS Kliniken Schwerin GmbH
Department Name
Klinik für Urologie
Contact Person Name
Chris Protzel
Site Name
University Hospital Jena KöR
Department Name
Klinik und Poliklinik für Urologie
Contact Person Name
Marc Grimm
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Klinik für Urologie
Contact Person Name
Maria de Santis
Contact Person Email
uro-onkologie@charite.de
Site Name
Universitaetsklinikum Muenster AöR
Department Name
Klinik für Urologie und Kinderurologie
Contact Person Name
Martin Bögemann
Contact Person Email
martin.boegemann@ukmuenster.de
Site Name
Universitaetsklinikum Schleswig-Holstein
Department Name
Klinik für Urologie
Contact Person Name
Axel Merseburger
Contact Person Email
axel.merseburger@uksh.de
Site Name
Universitaetsklinikum Bonn AöR
Department Name
Klinik und Poliklinik für Urologie und Kinderurologie
Contact Person Name
Philipp Krausewitz
Contact Person Email
studienzentrale-szb@ukbonn.de
Site Name
Klinikum rechts der Isar der TU Muenchen AöR
Department Name
Urologische Klinik und Poliklinik der Technischen Universität München
Contact Person Name
Margitta Retz
Contact Person Email
Margitta.Retz@tum.de
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Zentrum für Onkologie, II. Medizinische Klinik und Poliklinik
Contact Person Name
Gunhild von Amsberg
Contact Person Email
g.von-amsberg@uke.de

Ireland

Earliest CTIS Part Ii Submission Date
02-02-2024
Latest Decision Or Authorization Date
10-02-2026
Processing Time Days
739
Number Of Sites
2
Number Of Participants
10

Sites

Site Name
Tallaght University Hospital
Department Name
Tallaght
Contact Person Name
Sean Raymond McDermott
Contact Person Email
ray.mcdermottt@tuh.ie
Site Name
St Vincent's University Hospital
Department Name
St Vincent's
Contact Person Name
Sean Raymond McDermott
Contact Person Email
ray.mcdermottt@tuh.ie

Netherlands

Earliest CTIS Part Ii Submission Date
20-02-2024
Latest Decision Or Authorization Date
11-02-2026
Processing Time Days
722
Number Of Sites
11
Number Of Participants
35

Sites

Site Name
Haga Hospital
Department Name
Department of Oncology
Contact Person Name
Danny Houtsma
Contact Person Email
d.houtsma@hagaziekenhuis.nl
Site Name
Stichting Radboud University Medical Center
Department Name
Department of Oncology
Contact Person Name
Niven Mehra
Contact Person Email
Studies.onco@radboudumc.nl
Site Name
Zuyderland Medisch Centrum Stichting
Department Name
Department of Oncology
Contact Person Name
Franchette van den Berkmortel
Site Name
Meander Medisch Centrum Stichting
Department Name
Department of Oncology
Contact Person Name
Joyce van Dodewaard
Contact Person Email
jm.van.dodewaard@meandermc.nl
Site Name
St. Elisabeth Hospital Tilburg
Department Name
Department of Oncology
Contact Person Name
Robbert van Alphen
Contact Person Email
r.vanalphen@etz.nl
Site Name
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Department Name
Medical Oncology
Contact Person Name
Andre Bergman
Contact Person Email
a.bergman@nki.nl
Site Name
Stichting Amsterdam UMC
Department Name
Medical Oncology
Contact Person Name
Alfonsus van den Eertwegh
Contact Person Email
medonc-urology@amsterdamumc.nl
Site Name
Stichting Viecuri Medisch Centrum voor Noord-Limburg
Department Name
Medical Oncology
Contact Person Name
Philo Werner
Contact Person Email
trialsoncologie@viecuri.nl
Site Name
Sint Franciscus Vlietland Groep Stichting
Department Name
Department of Oncology
Contact Person Name
Paul Hamberg
Contact Person Email
p.hamberg@franciscus.nl
Site Name
Spaarne Gasthuis Stichting
Department Name
Medical Oncology
Contact Person Name
Aart Beeker
Contact Person Email
ABeeker@spaarnegasthuis.nl
Site Name
Medisch Centrum Leeuwarden B.V.
Department Name
Medical Oncology
Contact Person Name
Bart Rikhof

Denmark

Earliest CTIS Part Ii Submission Date
29-02-2024
Latest Decision Or Authorization Date
10-02-2026
Processing Time Days
712
Number Of Sites
3
Number Of Participants
20

Sites

Site Name
Lillebaelt Hospital
Department Name
Department of Oncology
Contact Person Name
Ahmed Zedan
Contact Person Email
Ahmed.Zedan@rsyd.dk
Site Name
Odense University Hospital
Department Name
Department of Oncology
Contact Person Name
Steinbjørn Hansen
Contact Person Email
Steinbjoern.Hansen@rsyd.dk
Site Name
Rigshospitalet
Department Name
Department of Oncology
Contact Person Name
Jakob Lauritsen
Contact Person Email
Jakob.Lauritsen@regionh.dk

Hungary

Earliest CTIS Part Ii Submission Date
22-01-2024
Latest Decision Or Authorization Date
16-02-2026
Processing Time Days
756
Number Of Sites
4
Number Of Participants
25

Sites

Site Name
Bacs-Kiskun Varmegyei Oktatokorhaz
Department Name
Onkoradiológiai Központ
Contact Person Name
Judit Kocsis
Contact Person Email
kocsisj@kmk.hu
Site Name
Orszagos Onkologiai Intezet
Department Name
Urogenitális Tumorok és Klinikai Farmakológiai Osztály, Kemoterápia C
Contact Person Name
Krisztián Nagyiványi
Contact Person Email
nagyivanyi.krisztian@oncol.hu
Site Name
University Of Debrecen
Department Name
Onkológiai Klinika
Contact Person Name
Péter Árkosy
Contact Person Email
arkosy.peter@med.unideb.hu
Site Name
Szent Lazar Megyei Korhaz
Department Name
Onkológia és Sugárterápiás Osztály
Contact Person Name
László Landherr
Contact Person Email
landherr@szlmk.hu

France

Earliest CTIS Part Ii Submission Date
07-03-2024
Latest Decision Or Authorization Date
13-02-2026
Processing Time Days
708
Number Of Sites
8
Number Of Participants
55

Sites

Site Name
Centre De Lutte Contre Le Cancer Eugene Marquis
Department Name
Medical Oncology
Contact Person Name
Brigitte Laguerre
Contact Person Email
b.laguerre@rennes.unicancer.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Medical Oncology
Contact Person Name
Stéphane Oudard
Contact Person Email
stephane.oudard@aphp.fr
Site Name
Centre Hospitalier Universitaire De Nimes
Department Name
Medical Oncology
Contact Person Name
Nadine Houédé
Contact Person Email
nadine.houede@chu-nimes.fr
Site Name
Institut Gustave Roussy
Department Name
Medical Oncology
Contact Person Name
Flippot Ronan
Contact Person Email
ronan.flippot@gustaveroussy.fr
Site Name
Centre Jean Perrin
Department Name
Oncology
Contact Person Name
Hakim Mahammedi
Site Name
Centre Hospitalier De La Cote Basque
Department Name
Medical Oncology
Contact Person Name
Louis François
Contact Person Email
lfrancois@ch-cotebasque.fr
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Medical Oncology
Contact Person Name
Philippe Barthélémy
Contact Person Email
p.barthelemy@icans.eu
Site Name
Centre Oscar Lambret
Department Name
Dept. of Oncology
Contact Person Name
Karim Fizazi
Contact Person Email
k-fizazi@o-lambret.fr

Sponsor

Primary sponsor

Full Name
Merck Sharp & Dohme LLC
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Eresearchtechnology Inc.
Responsibilities
sponsorDuties codes: [7]
Name
Almac Clinical Technologies LLC
Responsibilities
sponsorDuties codes: [3]
Name
Parexel International Corp.
Responsibilities
Medical information (Physician Consulting)
Name
Perceptive Eclinical Limited
Responsibilities
EUB Call center and medical escalation service
Name
Bioclinica Inc.
Responsibilities
Central imaging

Third parties

  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"sponsorDuties codes: [7]","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services S.a.r.l.","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"sponsorDuties codes: [3]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"Medical information (Physician Consulting)","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Perceptive Eclinical Limited","duties_or_roles":"EUB Call center and medical escalation service","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Guardant Health Inc.","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Central imaging","organisation_type":"Laboratory/Research/Testing facility"}

Investigational products

Investigational Product Name
Opevesostat
Active Substance
OPEVESOSTAT TOSILATE
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL
Frequency
Not specified (max daily amount provided)
Maximum Dose
10 mg (maxDailyDoseAmount)
Combination Treatment
Yes

Related trials

Other published trials that may interest you.