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
19-03-2024

Trial design

Randomised, open-label, abiraterone acetate (up to 1000 mg daily) or enzalutamide (up to 160 mg daily); corticosteroids such as prednisone/prednisolone (up to 10 mg daily) as per comparator regimen-controlled Phase III trial in Latvia, Ireland, Hungary and others.

Randomised
Yes
Open Label
Yes
Comparator
Abiraterone acetate (up to 1000 mg daily) or Enzalutamide (up to 160 mg daily); corticosteroids such as prednisone/prednisolone (up to 10 mg daily) as per comparator regimen
Target Sample Size
1076

Eligibility

Recruits 1076 No vulnerable populations selected. Trial population is adult male participants; informed consent is obtained from participants. No assent process for minors is mentioned..

Vulnerable Population
No vulnerable populations selected. Trial population is adult male participants; informed consent is obtained from participants. No assent process for minors is mentioned.

Inclusion criteria

  • {"criterion_text":"- Have histologically or cytologically confirmed adenocarcinoma of the prostate without small cell histology\n- 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\n- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening\n- Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement therapy (HRT) or participants who have ≤Grade 2 neuropathy or ≤Grade 2 osteopenia/osteoporosis are eligible\n- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)\n- Has prostate cancer progression while receiving androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months before screening\n- Has current evidence of distant metastatic disease (M1 disease) documented by either bone lesions on bone scan and/or soft tissue disease shown by computed tomography (CT)/magnetic resonance imaging (MRI)\n- Has disease that progressed during or after treatment with one next-generation hormonal agent (NHA) for hormone sensitive prostate cancer (HSPC) (metastatic hormone-sensitive prostate cancer [mHSPC] or non-metastatic hormone-sensitive prostate cancer [nmHSPC]), or castration-resistant prostate cancer (CRPC) (metastatic castration-resistant prostate cancer [mCRPC[ or non-metastatic castration-resistant prostate cancer [nmCRPC]), for at least 8 weeks of NHA treatment (at least 14 weeks of NHA treatment for participants with bone progression). Note: Participants may have received abiraterone acetate and docetaxel or darolutamide and docetaxel for HSPC. However, participants must have received no more than 6 cycles of docetaxel and had no radiographic disease progression while receiving docetaxel\n- 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\n- Has ongoing androgen deprivation therapy (ADT) with serum testosterone <50 ng/dL (<1.7 nM)\n- Has an eastern clinical oncology group (ECOG) performance status of 0 or 1 assessed within 10 days before randomization\n- Has adequate organ function\n- Has provided tumor tissue from a fresh core or excisional biopsy from soft tissue not previously irradiated. Samples from tumors progressing at a prior site of radiation are allowed"}

Exclusion criteria

  • {"criterion_text":"- Has presence of gastrointestinal condition\n- Has a history of clinically significant ventricular arrhythmias or Mobitz II second degree or third-degree heart block without a permanent pacemaker in place\n- Has received a taxane-based chemotherapy for metastatic castration-resistant prostate cancer (mCRPC)\n- Has not adequately recovered from major surgery or have ongoing surgical complications\n- Is currently being treated with Cytochrome P450 (CYP450)-inducing antiepileptic drugs for seizures\n- Participants on an unstable dose of thyroid hormone therapy, as judged by the investigator, within 6 months before the start of the study intervention\n- Receives prior radiotherapy within 2 weeks before the first dose of study intervention, or radiation-related toxicities, requiring corticosteroids\n- Receives prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention\n- Has systemic use of strong Cytochrome P450 3A4 (CYP3A4) inducers and P-glycoprotein (P-gp) inhibitors within 2 weeks before the first dose of study intervention\n- Has received prior targeted small molecule therapy or NHA treatment within 4 weeks before the first dose of study intervention\n- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention\n- Is unable to swallow capsules/tablets\n- Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration\n- Has known hypersensitivity to the components or excipients in abiraterone acetate, prednisone or prednisolone, enzalutamide, fludrocortisone, dexamethasone, or opevesostat (MK-5684)\n- Has a \"superscan\" bone scan defined as an intense symmetric activity in the bones and diminished renal parenchymal activity on baseline bone scan such that the presence of additional metastases in the future could not be evaluated\n- Has known additional malignancy that is progressing or has required active treatment within the past 3 years\n- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication\n- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, (ie, without evidence of progression) for at least 4 weeks as confirmed by repeat imaging performed during study screening, are clinically stable and have not required steroid treatment for at least 14 days prior to the first dose of study intervention\n- Has active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy is allowed\n- Active infection requiring systemic therapy\n- Has concurrent active Hepatitis B virus and Hepatitis C virus infection\n- Has history of pituitary dysfunction\n- Has poorly controlled diabetes mellitus\n- Has clinically significant abnormal serum potassium or sodium level.\n- Has any of the following at Screening Visit: Hypotension: systolic blood pressure (BP) <110 mmHg, or uncontrolled hypertension: systolic BP ≥160mmHg or diastolic blood BP ≥90 mmHg, in 2 out of the 3 recordings with optimized antihypertensive therapy\n- Has a history of active or unstable cardio/cerebrovascular disease, including thromboembolic events\n- Has history or family history of long QTc syndrome\n- Has a history of seizure(s) within 6 months before providing documented informed consent (IC) or has any condition that may predispose to seizure within 12 months prior to the date of enrollment"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Radiographic Progression-free Survival (rPFS)","definition_or_measurement_approach":"rPFS per PCWG Modified RECIST 1.1, as assessed by Blinded Independent Central Review (BICR)"}

Secondary endpoints

  • {"endpoint_text":"- Overall Survival (OS)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Time to Initiation of the First Subsequent Anticancer Therapy (TFST)","definition_or_measurement_approach":"Time from randomization to initiation of first subsequent anticancer therapy"}
  • {"endpoint_text":"- Objective Response Rate (ORR)","definition_or_measurement_approach":"Objective Response per PCWG Modified RECIST 1.1 as assessed by BICR"}
  • {"endpoint_text":"- Duration of Response (DOR)","definition_or_measurement_approach":"Duration of response per PCWG Modified RECIST 1.1 as assessed by BICR"}
  • {"endpoint_text":"- Time to Pain Progression (TTPP)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) Total Score","definition_or_measurement_approach":"Change from baseline in FACT-G total score"}
  • {"endpoint_text":"- Time to Deterioration (TTD) in FACT-G Total Score","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Overall Improvement in FACT-G Total Score","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Time to Prostate-specific Antigen (PSA) progression","definition_or_measurement_approach":""}
  • {"endpoint_text":"- PSA Response Rate","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Time to first symptomatic skeletal-related event (TSSRE)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Number of Participants Who Experience an Adverse Event (AE)","definition_or_measurement_approach":"Count of participants experiencing any adverse event"}
  • {"endpoint_text":"- Number of Participants Who Discontinue Study Treatment Due to an AE","definition_or_measurement_approach":"Count of participants who discontinue study treatment due to an adverse event"}

Recruitment

Planned Sample Size
1076
Recruitment Window Months
93
Consent Approach
Informed consent obtained from adult participants. Country-specific main consent forms and supporting optional consents are provided (examples in the submission: L1_ICF_Main consent files in local languages and English such as LVA_LV, LVA_RU, IRL_EN, FRA_FR, PRT_PT/EN, SWE_SV, CZE_CS, DEU_DE, ITA_IT, etc.). Optional consent documents for limited screening, genetic consent, optional payment (Greenphire/ClinCard), and pregnancy follow-up are available where applicable. No assent process for minors is described.

Geography

Total Number Of Sites
70
Total Number Of Participants
401

Latvia

Earliest CTIS Part Ii Submission Date
14-02-2024
Latest Decision Or Authorization Date
21-03-2024
Processing Time Days
36
Number Of Sites
2
Number Of Participants
12

Sites

Site Name
Pauls Stradins Clinical University Hospital
Department Name
Urology Center
Contact Person Name
Egils Vjaters
Contact Person Email
vjaters@gmail.com
Site Name
Liepajas Regionala Slimnica SIA
Contact Person Name
Dzintra Litavniece
Contact Person Email
auzniece@inbox.lv

Ireland

Earliest CTIS Part Ii Submission Date
02-02-2024
Latest Decision Or Authorization Date
22-03-2024
Processing Time Days
49
Number Of Sites
2
Number Of Participants
15

Sites

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

Hungary

Earliest CTIS Part Ii Submission Date
31-01-2024
Latest Decision Or Authorization Date
04-04-2024
Processing Time Days
64
Number Of Sites
4
Number Of Participants
25

Sites

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
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
Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz
Department Name
Klinikai Onkológiai és Sugárterápiás Centrum
Contact Person Name
Dombovári Gergely
Contact Person Email
dombovaridr@freemail.hu

Slovakia

Earliest CTIS Part Ii Submission Date
12-03-2024
Latest Decision Or Authorization Date
19-03-2024
Processing Time Days
7
Number Of Sites
3
Number Of Participants
24

Sites

Site Name
Uroexam spol. s r.o.
Department Name
Urologická ambulancia
Contact Person Name
Marek Brezovský
Contact Person Email
urologmarko@yahoo.com
Site Name
Privatna Urologicka Ambulacia s.r.o.
Department Name
Privatna Urologicka Ambulancia s.r.o.
Contact Person Name
Roman Sokol
Contact Person Email
roman.sokol@urology.sk
Site Name
Narodny Onkologicky Ustav
Department Name
II. onkologická klinika LF UK a NOÚ,Oddelenie klinickej onkológie D
Contact Person Name
Michal Mego
Contact Person Email
michal.mego@nou.sk

Portugal

Earliest CTIS Part Ii Submission Date
19-01-2024
Latest Decision Or Authorization Date
20-03-2024
Processing Time Days
61
Number Of Sites
6
Number Of Participants
20

Sites

Site Name
Unidade Local De Saude De Santa Maria E.P.E.
Department Name
Medical Oncology
Contact Person Name
Raquel Brás
Contact Person Email
cic@chln.min-saude.pt
Site Name
CCAB Centro Clinico Academico Braga Associacao
Department Name
CCAB - Centro Clinico Académico Braga Associação
Contact Person Name
Ricardo Fernandes
Site Name
Unidade Local De Saude De Santo Antonio E.P.E.
Department Name
Oncology Service
Contact Person Name
Silvia Lopes
Contact Person Email
u12712@chporto.min-saude.pt
Site Name
Unidade Local De Saude De Gaia/Espinho E.P.E.
Department Name
Medical Oncology
Contact Person Name
Andreia Capela
Site Name
Galo Saude Parcerias Cascais S.A.
Department Name
Medical Oncology
Contact Person Name
Gizela Rocha
Site Name
Hospital Cuf Tejo S.A.
Department Name
Medical Oncology and Hematology
Contact Person Name
Mariana Malheiro
Contact Person Email
mariana.rodrigues@cuf.pt

Sweden

Earliest CTIS Part Ii Submission Date
23-02-2024
Latest Decision Or Authorization Date
21-03-2024
Processing Time Days
27
Number Of Sites
2
Number Of Participants
10

Sites

Site Name
Uppsala University Hospital
Department Name
Onkologmottagningen
Contact Person Name
Ingrida Verbienné
Contact Person Email
ingrida.verbiene@akademiska.se
Site Name
Karolinska University Hospital
Department Name
Mottagning Urologiska sjukdomar Solna
Contact Person Name
Anna Jrustuabseb

Romania

Earliest CTIS Part Ii Submission Date
27-11-2023
Latest Decision Or Authorization Date
25-03-2024
Processing Time Days
119
Number Of Sites
5
Number Of Participants
20

Sites

Site Name
Spitalul Clinic Prof.Dr.Theodor Burghele
Department Name
Urologie
Contact Person Name
Viorel Jinga
Contact Person Email
contact@burghele.ro
Site Name
Spitalul Clinic De Urgenta Prof Dr Agrippa Ionescu
Department Name
Oncologie Medicala
Contact Person Name
Cornelia Nitipir
Contact Person Email
secretariat.agrippa@dcti.ro
Site Name
Centrul De Oncologie SF Nectarie S.R.L.
Department Name
Departament Oncologie Medicala
Contact Person Name
Michel Schenker
Contact Person Email
office@centruldeoncologie.ro
Site Name
Spitalul Clinic Municipal Cluj-Napoca
Department Name
Departament Oncologie
Contact Person Name
Ramona Matei
Contact Person Email
office@spitalclujana.ro
Site Name
Delta Health Care S.R.L.
Department Name
Departament Oncologie
Contact Person Name
Andrea Craciunescu
Contact Person Email
alis.mihai@reginamaria.ro

France

Earliest CTIS Part Ii Submission Date
04-03-2024
Latest Decision Or Authorization Date
19-03-2024
Processing Time Days
15
Number Of Sites
10
Number Of Participants
75

Sites

Site Name
GIE Groupe hospitalier Paris Saint-Joseph/Vinci
Department Name
Oncology
Contact Person Name
Carole Helissey
Contact Person Email
chelissey@ghpsj.fr
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Oncology
Contact Person Name
Benjamin Auberger
Contact Person Email
benjamin.auberger@chu-brest.fr
Site Name
Hospital Foch
Department Name
Oncology
Contact Person Name
Raffaele Ratta
Contact Person Email
r.ratta@hopital-foch.com
Site Name
Capio La Croix Du Sud
Department Name
Oncology
Contact Person Name
Guillaume Ploussard
Contact Person Email
dr.gploussard@gmail.com
Site Name
Centre Leon Berard
Department Name
Oncology
Contact Person Name
Aude Fléchon
Contact Person Email
aude.flechon@lyon.unicancer.fr
Site Name
HPM Nord
Department Name
Centre de Radiothérapie et d'Oncologie Bourgogne
Contact Person Name
Ségolène Hautecloque
Contact Person Email
shautecloque@clinique-psv.fr
Site Name
Institut Bergonie
Department Name
Oncology
Contact Person Name
Guilhem Roubaud
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Medical Oncology
Contact Person Name
Philippe Barthelemy
Contact Person Email
p.barthelemy@icans.eu
Site Name
Institut Gustave Roussy
Department Name
Medical Oncology
Contact Person Name
Ronan Flippot
Contact Person Email
ronan.flippot@gustaveroussy.fr
Site Name
Centre Jean Perrin
Department Name
Oncology
Contact Person Name
Hakim Mahammedi

Spain

Earliest CTIS Part Ii Submission Date
23-02-2024
Latest Decision Or Authorization Date
22-03-2024
Processing Time Days
28
Number Of Sites
8
Number Of Participants
40

Sites

Site Name
Hospital Universitari De Girona Doctor Josep Trueta
Department Name
Medical Oncology
Contact Person Name
Nuria Sala González
Contact Person Email
nsgonzalez@iconcologia.net
Site Name
Hospital Quironsalud Malaga
Department Name
Oncology
Contact Person Name
Manuel Cobo Dols
Contact Person Email
manuelcobodols@yahoo.es
Site Name
Complejo Hospitalario Universitario Insular Materno Infantil
Department Name
Medical Oncology
Contact Person Name
Alfonso Gómez de Liaño
Contact Person Email
agomlis@gobiernodecanarias.org
Site Name
Hospital Clinic De Barcelona
Department Name
Oncology
Contact Person Name
Begoña Mellado González
Contact Person Email
bmellado@clinic.cat
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Oncology
Contact Person Name
Aurea Molina Diaz
Contact Person Email
aurea.molina.diaz@sergas.es
Site Name
Hospital Universitario De Burgos
Department Name
Oncología
Contact Person Name
Guillermo Crespo Herrero
Contact Person Email
gcrespo@saludcastillayleon.es
Site Name
Hospital Universitario Quironsalud Madrid
Department Name
Oncology
Contact Person Name
Jesús Miranda Pomo
Contact Person Email
jesus.miranda@quironsalud.es
Site Name
Parc Tauli Hospital Universitari
Department Name
Oncology
Contact Person Name
Enrique Gallardo Díaz
Contact Person Email
egallardo@tauli.cat

Lithuania

Earliest CTIS Part Ii Submission Date
18-01-2024
Latest Decision Or Authorization Date
25-03-2024
Processing Time Days
67
Number Of Sites
2
Number Of Participants
12

Sites

Site Name
Viesosios istaigos Vilniaus universiteto ligonines Santaros kliniku filialas Nacionalinis vezio centras
Department Name
.
Contact Person Name
Albertas Ulys
Contact Person Email
albertas.ulys@nvi.lt
Site Name
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
Department Name
Urology Clinic
Contact Person Name
Mindaugas Jievaltas
Contact Person Email
mjievaltas@gmail.com

Estonia

Earliest CTIS Part Ii Submission Date
19-02-2024
Latest Decision Or Authorization Date
22-03-2024
Processing Time Days
32
Number Of Sites
4
Number Of Participants
15

Sites

Site Name
Sihtasutus Parnu Haigla
Department Name
Surgery Clinic
Contact Person Name
Helis Pokker
Site Name
East Tallinn Central Hospital
Department Name
Centre of Oncology
Contact Person Name
Elen Vettus
Contact Person Email
elen.vettus@itk.ee
Site Name
North Estonia Medical Centre Foundation
Department Name
Oncology and Hematology Clinic
Contact Person Name
Helis Pokker
Site Name
Tartu University Hospital
Department Name
Haematology and Oncology Clinic, Radio- and oncotherapy Centre
Contact Person Name
Marju Kase
Contact Person Email
marju.kase@kliinikum.ee

Greece

Earliest CTIS Part Ii Submission Date
27-11-2023
Latest Decision Or Authorization Date
26-03-2024
Processing Time Days
120
Number Of Sites
2
Number Of Participants
18

Sites

Site Name
Alexandra Hospital
Department Name
Oncology-Hematology department, Unit of Plasma cell dyscrasias
Contact Person Name
Flora Zagouri
Contact Person Email
florazagouri@yahoo.co.uk
Site Name
University General Hospital Attikon
Department Name
2nd Propaedeutic Department of Medicine
Contact Person Name
Aristotelis Bamias
Contact Person Email
abamias@med.uoa.gr

Czechia

Earliest CTIS Part Ii Submission Date
20-02-2024
Latest Decision Or Authorization Date
19-03-2024
Processing Time Days
28
Number Of Sites
4
Number Of Participants
40

Sites

Site Name
Fakultni Nemocnice U Sv Anny V Brne
Department Name
Oddělení onkologicko-chirurgicke A1
Contact Person Name
Jana Katolická
Contact Person Email
jana.katolicka@fnusa.cz
Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
Onkologická klinika
Contact Person Name
Martin Matějů
Contact Person Email
martin.mateju@vfn.cz
Site Name
University Hospital Olomouc
Department Name
Onkologická klinika FN Olomouc
Contact Person Name
Hana Študentová
Contact Person Email
hana.studentova@fnol.cz
Site Name
Masarykuv Onkologicky Ustav
Department Name
Klinika komplexní onkologické péče
Contact Person Name
Jiří Navrátil
Contact Person Email
jnavratil@mou.cz

Germany

Earliest CTIS Part Ii Submission Date
14-03-2024
Latest Decision Or Authorization Date
20-03-2024
Processing Time Days
6
Number Of Sites
10
Number Of Participants
55

Sites

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
Urologicum Duisburg
Department Name
Urologicum Duisburg
Contact Person Name
Eva Hellmis
Contact Person Email
hellmis@urologicum-duisburg.de
Site Name
Klinikum rechts der Isar der TU Muenchen AöR
Department Name
Urologische Klinik und Poliklinik
Contact Person Name
Margitta Retz
Contact Person Email
margitta.retz@tum.de
Site Name
National Center For Tumor Diseases (NCT) Heidelberg
Department Name
National Center For Tumor Diseases (NCT) Heidelberg. Klinik f. Medizinische Onkologi
Contact Person Name
Stefanie Zschäbitz
Site Name
Studienpraxis Urologie Susan Feyerabend MD Tilman Todenhoefer MD PhD GbR
Contact Person Name
Tilman Todenhöfer
Contact Person Email
praxis@studienurologie.de
Site Name
University Hospital Cologne AöR
Department Name
Klinik für Urologie, Uro-Onkologie spezielle urologische und roboter-assistierte Chirurgie Poliklini
Contact Person Name
Pia Paffenholz
Site Name
St. Marien-Krankenhaus GmbH
Department Name
Urologie u. Kinderurologie
Contact Person Name
Stefan Machtens
Site Name
Universitaetsklinikum Regensburg AöR
Department Name
Klinik für Urologie
Contact Person Name
Marco Julius Schnabel
Contact Person Email
mschnabel@csj.de
Site Name
Vivantes Netzwerk fuer Gesundheit GmbH
Department Name
Klinik für Urologie
Contact Person Name
Stefan Hinz
Contact Person Email
stefan.hinz@vivantes.de
Site Name
Universitaetsmedizin Goettingen
Department Name
Klinik für Urologie
Contact Person Name
Arne Strauss

Italy

Earliest CTIS Part Ii Submission Date
29-01-2024
Latest Decision Or Authorization Date
20-03-2024
Processing Time Days
51
Number Of Sites
6
Number Of Participants
20

Sites

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
Site Name
Azienda Ospedaliera Per L'Emergenza Cannizzaro
Department Name
U.O.C di Oncologia Medica
Contact Person Name
Giuseppa Scandurra
Contact Person Email
giusy.scandurra@gmail.com
Site Name
Azienda Ospedaliero Universitaria Ospedali Riuniti
Department Name
Oncologia Medica e Terapia Biomolecolare
Contact Person Name
Matteo Landriscina
Contact Person Email
matteo.landriscina@unifg.it
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
Struttura Complessa Oncologia Medica 1
Contact Person Name
Giuseppe Procopio
Site Name
Azienda Ospedaliera S Maria Di Terni
Department Name
S.C. Oncologia Medica e Traslazionale
Contact Person Name
Annalisa Guida
Contact Person Email
a.guida@aospterni.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Oncologia Medica
Contact Person Name
Andrea Necchi
Contact Person Email
necchi.andrea@hsr.it

Sponsor

Primary sponsor

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

Contract research organisations

Name
Bioclinica Inc.
Responsibilities
Central imaging
Name
Parexel International Corp.
Responsibilities
Medical information (Physician Consulting)
Name
Almac Clinical Technologies LLC
Name
Labcorp Central Laboratory Services S.a.r.l.
Name
Ardena Bioanalysis B.V.
Name
Guardant Health Inc.
Name
Eresearchtechnology Inc.

Third parties

  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Central imaging","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Netherlands","full_name":"Ardena Bioanalysis B.V.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services S.a.r.l.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Guardant Health Inc.","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"Medical information (Physician Consulting)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Opevesostat
Active Substance
OPEVESOSTAT TOSILATE
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL
Maximum Dose
10 mg
Combination Treatment
Yes

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