Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
1,448
Countries
13
Sites
85
Metastatic Castration-Resistant Prostate Cancer
1. To compare Ifinatamab deruxtecan (I-DXd) to docetaxel with respect to overall survival (OS) in participants with mCRPC. 2. To compare I-DXd to docetaxel with respect to radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG) Modified Response Evaluation Criteria in Solid Tumors Versi…
Key facts
- Sponsor
- Merck Sharp & Dohme LLC
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 23 Jun 2025 → ongoing
- Decision date (initial)
- 2025-06-11
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Daiichi Sankyo · Merck Sharp & Dohme LLC
External identifiers
- EU CT number
- 2024-517423-40-00
- WHO UTN
- U1111-1312-2498
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacogenomic, Safety, Pharmacogenetic, Pharmacokinetic, Efficacy, Pharmacodynamic
1. To compare Ifinatamab deruxtecan (I-DXd) to docetaxel with respect to overall survival (OS) in participants with mCRPC.
2. To compare I-DXd to docetaxel with respect to radiographic progression-free survival (rPFS) 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 (BICR) in participants with mCRPC.
Secondary objectives 7
- To evaluate the TFST of participants treated with I-DXd compared with participants treated with docetaxel.
- To evaluate the OR and DOR per PCWG Modified RECIST 1.1 as assessed by BICR of participants treated with I-DXd compared with participants treated with docetaxel.
- To evaluate the Time to Pain Progression (TTPP) of participants treated with I-DXd compared with participants treated with docetaxel.
- To evaluate the time to PSA progression of participants treated with I-DXd compared with participants treated with docetaxel.
- To evaluate the PSA response rate of participants treated with I-DXd compared with participants treated with docetaxel.
- To evaluate the time to first SSRE of participants treated with I-DXd compared with participants treated with docetaxel.
- To evaluate the safety and tolerability of I-DXd.
Conditions and MedDRA coding
Metastatic Castration-Resistant Prostate Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.0 | LLT | 10001198 | Adenocarcinoma of the prostate metastatic | 10029104 |
| 21.1 | LLT | 10076506 | Castration-resistant prostate cancer | 10029104 |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- Yes
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology
- Has prostate cancer progression while on androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months prior to Screening
- Has current evidence of metastatic disease documented by either bone lesions on bone scan and/or soft tissue disease by computed tomography (CT)/magnetic resonance imaging (MRI)
- Has received prior treatment with 1 or 2 androgen receptor pathway inhibitors (ARPIs) and progressed during or after at least 8 weeks of treatment
- Has provided tumor tissue from a core or excisional biopsy from soft tissue not previously irradiated and obtained after disease progression on the most recent prior therapy
- Has recovered from adverse events (AEs) due to previous anticancer therapies
Exclusion criteria 7
- Is unable to swallow tablets/capsules
- Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids or has current ILD/pneumonitis
- Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
- Has uncontrolled or significant cardiovascular disease
- Has received prior treatment with a taxane-based chemotherapy agent for metastatic castration-resistant prostate cancer (mCRPC)
- Has had prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (eg, trastuzumab deruxtecan) due to treatment-related toxicities
- Has a “superscan” bone scan
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Overall Survival (OS)
- Radiographic progression-free survival (rPFS)
Secondary endpoints 9
- Time to first subsequent therapy (TFST)
- Objective response rate (ORR)
- Duration of Response (DOR)
- Time to pain progression (TTPP)
- Time to prostate-specific antigen (PSA) progression
- PSA response rate
- Time to first symptomatic skeletal-related events (SSRE)
- Number of Participants Who Experience One or More Adverse Events (AEs)
- Number of Participants Who Discontinue Study Treatment Due to an AE
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD11627628 · Product
- Active substance
- Ifinatamab Deruxtecan
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 12 mg/kg milligram(s)/kilogram
- Max total dose
- 0 mg/g milligram(s)/gram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- MERCK & CO. INC.
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 3
SCP126226 · ATC
- Active substance
- Docetaxel
- Substance synonyms
- DOCETAXEL ANHYDROUS
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 75 mg/m2 milligram(s)/square meter
- Max total dose
- 750 mg/m2 milligram(s)/square meter
- Max treatment duration
- 30 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01CD02 — DOCETAXEL
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Betamethasone Sodium Phosphate
SCP107974752 · ATC
- Active substance
- Betamethasone Sodium Phosphate
- Substance synonyms
- BETAMETHASONE DISODIUM PHOSPHATE
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 2200 mg milligram(s)
- Max treatment duration
- 33 Week(s)
- Authorisation status
- Authorised
- ATC code
- H02AB06 — PREDNISOLONE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP107216203 · ATC
- Active substance
- Prednisolone
- Substance synonyms
- (8S,9S,10S,11S,13S,14S,17R)-11,17-DIHYDROXY-17-(2-HYDROXYACETYL)-10,13-DIMETHYL-7,8,9,11,12,14,15,16-OCTAHYDRO-6H-CYCLOPENTA[A]PHENANTHREN-3-ONE, GLPG0303, DELTA-HYDROCORTISONE, 1,2-DEHYDROHYDROCORTISONE, METACORTANDRALONE
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 2200 mg milligram(s)
- Max treatment duration
- 33 Week(s)
- Authorisation status
- Authorised
- ATC code
- H02AB07 — PREDNISONE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 6
-
R01AD · Product
- Pharmaceutical form
- PHF00024MIG
- Route of administration
- OTHER USE
- Max daily dose
- 0 % (V/V) percent volume/volume
- Max total dose
- 0 % (V/V) percent volume/volume
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- R01AD — CORTICOSTEROIDS
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
-
A04AD · Product
- Pharmaceutical form
- PHF00008MIG
- Route of administration
- OTHER USE
- Max daily dose
- 0 % (V/V) percent volume/volume
- Max total dose
- 0 % (V/V) percent volume/volume
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- A04AD — OTHER ANTIEMETICS
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
-
R06A · Product
- Pharmaceutical form
- -
- Route of administration
- OTHER USE
- Max daily dose
- 0 % (V/V) percent volume/volume
- Max total dose
- 0 % (V/V) percent volume/volume
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- R06A — ANTIHISTAMINES FOR SYSTEMIC USE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP1081917 · ATC
- Active substance
- Buclizine Hydrochloride
- Substance synonyms
- Buclizine dihydrochloride
- Route of administration
- OTHER USE
- Max daily dose
- 0 % (V/V) percent volume/volume
- Max total dose
- 0 % (V/V) percent volume/volume
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N02BE01 — PARACETAMOL
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
-
A04AA · Product
- Pharmaceutical form
- PHF00244MIG
- Route of administration
- OTHER USE
- Max daily dose
- 0 % (V/V) percent volume/volume
- Max total dose
- 0 % (V/V) percent volume/volume
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- A04AA — SEROTONIN (5HT3) ANTAGONISTS
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
-
H02AB · Product
- Pharmaceutical form
- PHF00170MIG
- Route of administration
- OTHER USE
- Max daily dose
- 0 % (V/V) percent volume/volume
- Max total dose
- 0 % (V/V) percent volume/volume
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- H02AB — GLUCOCORTICOIDS
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Merck Sharp & Dohme LLC
- Sponsor organisation
- Merck Sharp & Dohme LLC
- Address
- 126 East Lincoln Avenue, P. O. Box 2000 P. O. Box 2000
- City
- Rahway
- Postcode
- 07065-4607
- Country
- United States
Scientific contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Jelena Todoric
Public contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Jelena Todoric
Third parties 7
| Organisation | City, country | Duties |
|---|---|---|
| Eresearchtechnology Inc. ORG-100013039
|
Philadelphia, United States | E-data capture |
| Ventana Medical Systems Inc. ORG-100043193
|
Oro Valley, United States | Laboratory analysis |
| Signant Health LLC ORG-100040732
|
Blue Bell, United States | Interactive response technologies (IRT) |
| Eresearchtechnology Inc. ORG-100013039
|
Philadelphia, United States | Other |
| Eresearchtechnology Inc. ORG-100013039
|
Philadelphia, United States | Other |
| Parexel International Corp. ORG-100007310
|
Auburndale, United States | Other |
| IQVIA Limited ORG-100008655
|
Livingston, United Kingdom | Laboratory analysis |
Locations
13 EU/EEA countries · 85 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruiting | 18 | 3 |
| Czechia | Ongoing, recruiting | 30 | 5 |
| Denmark | Ongoing, recruiting | 30 | 4 |
| France | Ongoing, recruiting | 70 | 9 |
| Germany | Ongoing, recruiting | 50 | 9 |
| Greece | Ongoing, recruiting | 28 | 5 |
| Ireland | Ongoing, recruiting | 15 | 3 |
| Italy | Ongoing, recruiting | 55 | 9 |
| Netherlands | Ongoing, recruiting | 58 | 13 |
| Norway | Ongoing, recruiting | 24 | 4 |
| Poland | Ongoing, recruiting | 30 | 6 |
| Spain | Ongoing, recruiting | 80 | 11 |
| Sweden | Ongoing, recruiting | 20 | 4 |
| Rest of world
Argentina, Australia, Israel, South Africa, United Kingdom, Peru, Brazil, Guatemala, Malaysia, United States, Japan, Korea, Republic of, Chile, Turkey, Hong Kong, Colombia, China, Thailand, Singapore, Mexico, Switzerland, Taiwan
|
— | 940 | — |
Investigational sites
Klinikum Wels-Grieskirchen GmbH
Abteilung für Innere Medizin IV, Grieskirchner Strasse 42, 4600, Wels
SCRI CCCIT Ges.m.b.H.
Universitätsklinik f. Innere Medizin III, Muellner Hauptstrasse 48, 5020, Salzburg
Ordensklinikum Linz GmbH
Abteilung für Urologie und Andrologie, Fadingerstrasse 1, 4020, Linz
Masarykuv Onkologicky Ustav
Klinika komplexní péče, Zluty Kopec 543/7, Stare Brno, Brno-Stred
University Hospital Olomouc
Onkologická klinika, Zdravotniku 248/7, 779 00, Olomouc
Fakultni Nemocnice V Motole
Onkologická klinika, V Uvalu 84/1, Motol, Prague
Fakultni Nemocnice Ostrava
Klinika onkologie, 17. Listopadu 1790/5, Poruba, Ostrava
Fakultni Nemocnice U Sv Anny V Brne
Onkologická klinika, Pekarska 53, Stare Brno, Brno-Stred
Odense University Hospital
Department of Oncology, J B Winsloews Vej 4, 5000, Odense C
Region Hovedstaden
Department of Oncology, Borgmester Ib Juuls Vej 1, 2730, Herlev
Lillebaelt Hospital
Department of Oncology, Beriderbakken 4, 7100, Vejle
Aalborg University Hospital
Department of Oncology, Hobrovej 18-22, 9000, Aalborg
CHU Besancon
Department of Medical Oncology, 3 Boulevard Alexandre Fleming, 25000, Besancon
Hospital Foch
Department of Medical Oncology, 40 Rue Worth, 92150, Suresnes
Institut De Cancerologie De Lorraine
Department of Medical Oncology, 6 Avenue De Bourgogne, Cs 30519, Vandoeuvre Les Nancy Cedex
Oncoradio Centre Oncogard
Department of Medical Oncology, Rue Du Professeur Henri Pujol Institut De Cancerologie, 30029, Nimes Cedex 9
Hopital Prive Clairval
Department of Radiotherapy, 317 Boulevard Du Redon, 13009, Marseille
Centre Hospitalier Universitaire Rouen
Department of Urology/ Oncology, 1 Rue De Germont, Bp 96031, Rouen Cedex
Centre Francois Baclesse
Department of Gynecology and Urology, 3 Avenue Du General Harris, Cs 45026, Caen Cedex 5
Polyclinique De Limoges
Department of Medical Oncology, 18 Rue Du General Catroux, 87039, Limoges Cedex I
Hopital Saint Louis
Department of Medical Oncology, 1 Avenue Claude Vellefaux, 75010, Paris
Studienpraxis Urologie Susan Feyerabend MD Tilman Todenhoefer MD PhD GbR
Studienpraxis Urologie, Steinengrabenstrasse 17, 72622, Nuertingen
University Medical Center Hamburg-Eppendorf
II. Medizinische Klinik und Poliklinik, Zentrum für Onkologie, Martinistrasse 52, Eppendorf, Hamburg
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Urologische Klinik und Poliklinik, Ismaninger Strasse 22, Au-Haidhausen, Munich
Urologicum Duisburg
Urologicum Duisburg, Fahrner Str 123, 47169, Duisburg
Universitaetsklinikum Schleswig-Holstein AöR
Klinik für Urologie, Ratzeburger Allee 160, 23538, Luebeck
Klinikum Der Landeshauptstadt Stuttgart gKAöR
Klinik für Urologie und Transplantationschirurgie, Kriegsbergstrasse 60, Mitte, Stuttgart
Charite Universitaetsmedizin Berlin KöR
Klinik für Urologie, Chariteplatz 1, Mitte, Berlin
Goethe University Frankfurt
Klinik für Urologie, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Klinikum Nuernberg
Klinik für Innere Medizin 5, Schwerpunkt Onkologie / Hämatologie, Prof.-Ernst-Nathan-Strasse 1, St. Johannis, Nuremberg
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
2nd Propaedeutic Internal Medicine Department, Rimini 1, 124 61, Chaidari
Metropolitan General Hospital Healthcare Facilities Operation And Management Single Member S.A.
Oncologic Clinical Trials and Research Clinic, Leoforos Mesogeion 264, 155 62, Cholargos
Athens Medical Center S.A.
GU Department of Oncology, Distomou 5-7, 151 25, Maroussi
Henry Dunant Hospital Center
4rth Oncology - Internal Medicine Department, 107 Mesogeion Avenue, 115 26, Athens
General Oncological Hospital Of Kifissia Agioi Anargyroi
Department of Medical Oncology, Timiou Stavrou And 14 Noufaron, 145 64, Kifissia
Cork University Hospital
Oncology, Wilton, T12 DC4A, Cork
Tallaght University Hospital
Oncology, Tallaght, D24 NR0A, Dublin 24
St Vincent's University Hospital
Oncology, Elm Park Merrion Road, D04 T6F4, Dublin 4
Fondazione IRCCS Istituto Nazionale Dei Tumori
Struttura Complessa Oncologia Medica 1, Via Giacomo Venezian 1, 20133, Milan
Azienda Ospedaliera Universitaria Senese
U.O.C. Immunoterapia Oncologica, Strada Delle Scotte 14, 53100, Siena
Centro Ricerche Cliniche Di Verona S.r.l.
Centro Ricerche Cliniche di Verona, Piazzale Ludovico Antonio Scuro 10, 37134, Verona
Azienda Unita' Sanitaria Locale Toscana Sud Est
U.O.C Oncologia Medica, Ospedale Area Aretina Nord, Via Pietro Nenni 20/22, Arezzo
Humanitas Mirasole S.p.A.
U.O di Oncologia Medica ed Ematologia, Via Alessandro Manzoni 56, 20089, Rozzano
Azienda Ospedaliera S Maria Di Terni
S.C. Oncologia Medica e Traslazionale, Viale Tristano Di Joannuccio 1, 05100, Terni
Azienda Ospedaliero Universitaria Ospedali Riuniti
Oncologia Medica e Terapia Biomolecolare Universitaria, Viale Luigi Pinto 1, 71122, Foggia
I.F.O. Istituti Fisioterapici Ospitalieri
Oncologia Medica 1, Via Elio Chianesi N 53, 00144, Rome
Cliniche Gavazzeni S.p.A.
UO Oncologia Medica, Via Mauro Gavazzeni 21, 24125, Bergamo
Stichting Martini Ziekenhuis
Department of Internal Medicine, Van Swietenplein 1, 9728 NT, Groningen
Stichting Viecuri Medisch Centrum voor Noord-Limburg
Department of Oncology, Tegelseweg 210, 5912 BL, Venlo
Sint Antonius Ziekenhuis Stichting
Department of Internal Medicine, Koekoekslaan 1, 3435 CM, Nieuwegein
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department of Internal Oncology, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Tergooiziekenhuizen
Internal medicine, Van Riebeeckweg 212, 1213 XZ, Hilversum
Ziekenhuisgroep Twente Stichting
Department of Oncology, Zilvermeeuw 1, 7609 PP, Almelo
Spaarne Gasthuis Stichting
Internal medicine / oncology, Spaarnepoort 1, 2134 TM, Hoofddorp
Haga Hospital
Department of Medical Oncology, Els Borst-Eilersplein 275, 2545 AA, 's-Gravenhage
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Department of Medical Oncology, Plesmanlaan 121, 1066 CX, Amsterdam
Meander Medisch Centrum
Department of Oncology, Maatweg 3, 3813 TZ, Amersfoort
Radboud universitair medisch centrum Stichting
Department of Medical Oncology, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Academisch Ziekenhuis Maastricht
Department of Oncology, P Debyelaan 25, 6229 HX, Maastricht
Sint Franciscus Vlietland Groep Stichting
Department of Oncology, Kleiweg 500, 3045 PM, Rotterdam
Sykehuset Innlandet HF
Department of Oncology and Center for Palliative Care Division Gjøvik, Furnesvegen 26, 2382, Brumunddal
Akershus University Hospital
Onkologisk avdeling, Sykehusveien 25, 1474, Loerenskog
Oslo University Hospital HF
Department of Oncology, Taarnbygget, Kirkeveien 166, Oslo
St. Olavs Hospital HF
Kreftklinikken, Prinsesse Kristinas G. 3, 7030, Trondheim
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Klinika Nowotworów Układu Moczowego, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Pratia S.A.
Pratia MCM Kraków, Ul. Pana Tadeusza 2, 30-727, Cracow
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o.
Siedleckie Centrum Onkologii, Ul. Ksiecia Jozefa Poniatowskiego 26, 08-110, Siedlce
Clinical Research Center Sp. z o.o. Medic-R sp.k.
NA, Ul. Feliksa Nowowiejskiego 5, 61-731, Poznan
Pratia Hematologia Sp. z o.o.
Pratia Onkologia Katowice, Ul. Tadeusza Kosciuszki 92, 40-519, Katowice
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Ambulatorium Chemioterapii, Ul. Izabeli Romanowskiej 2, 85-796, Bydgoszcz
Fundacion Instituto Valenciano De Oncologia
Oncologia medica, Calle Professor Beltran Baguena 8, 46009, Valencia
Hospital Universitario Virgen De Valme
Oncologia medica, Avenida Bellavista S/n, 41014, Sevilla
Hospital Universitario Quironsalud Madrid
Servicio de Oncologia, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital General Universitario Gregorio Maranon
Oncologia medica, Calle Del Doctor Esquerdo 46, 28009, Madrid
Complexo Hospitalario Universitario De Santiago
Servicio de Oncologia, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Universitario Lucus Augusti
Oncologia medica, Rua Dr. Ulises Romero 1, 27003, Lugo
Hospital Universitario Marques De Valdecilla
Oncologia medica, Avenida Valdecilla Sn, 39008, Santander
Hospital Universitario Reina Sofia
Oncologia medica, Avenida Menendez Pidal S/n, 14004, Cordoba
Hospital Universitario Puerta De Hierro De Majadahonda
Servicio de Oncologia, Calle De Manuel De Falla 1, 28222, Majadahonda
Hospital Universitari Vall D Hebron
Oncologia medica, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Del Mar
Oncologia medica, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Soedersjukhuset AB
Onkologi, Sjukhusbacken 10, Hogalid, Stockholm
Uppsala University Hospital
Onkologi, Akademiska Sjukhuset Ingang 86 B16, Pet Centrum, Uppsala
Karolinska University Hospital
ME Bäckencancer, Eugeniavagen 3, 171 64, Solna
Region Skane Skanes Universitetssjukhus
VO hematologi, onkologi och strålningsfysik, St. Johns, Fritz Bauers Gata 5, Malmo
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2025-07-11 | 2025-08-12 | |||
| Czechia | 2025-08-04 | 2025-11-10 | |||
| Denmark | 2025-06-23 | 2025-09-08 | |||
| France | 2025-06-26 | 2025-07-02 | |||
| Germany | 2025-06-23 | 2025-07-29 | |||
| Greece | 2025-08-05 | 2025-09-09 | |||
| Ireland | 2025-09-11 | 2025-09-18 | |||
| Italy | 2025-07-08 | 2025-08-05 | |||
| Netherlands | 2025-06-23 | 2025-07-10 | |||
| Norway | 2025-06-23 | 2025-07-29 | |||
| Poland | 2025-06-23 | 2025-08-06 | |||
| Spain | 2025-07-09 | 2025-08-14 | |||
| Sweden | 2025-06-26 | 2025-07-17 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 92 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-517423-40_GRC_EL_IN_for pub | 00R |
| Protocol (for publication) | D1_Protocol_2024-517423-40_IN_for pub | 01R |
| Protocol (for publication) | D4_Copyright Statement_BPI-SF_IN_for pub | 04Dec2024 |
| Protocol (for publication) | D4_Copyright Statement_FACT-P+EQ-5D_IN_for pub | 04Dec2024 |
| Protocol (for publication) | D4_Subject questionnaire_Analgesic_IN_for pub | 13Dec2024R |
| Protocol (for publication) | D4_Subject questionnaire_memo_AUT_DE_IN-RFI001_not pub | 1-0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_AUT_EN_IN_for pub | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_DEU_EN_IN_for pub | 1.00 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_DNK_EN_IN_for pub | 1.00 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_ESP_ES_IN_for pub | 28JAN2025R |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_FRA_FR_IN_for pub | 06FEB2025 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_GRC_EN_IN_for pub | 10FEB2025 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_IRL_EN_IN_for pub | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_ITA_EN_IN_for pub | 10FEB2025 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_NLD_EN_IN-RFI014_for pub | v3 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_NOR_EN_IN_for pub | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_POL_PL_IN_for pub | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_SWE_SV_IN_for pub | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_CZE_CS_IN_for pub | 03FEB2025 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Brochure_CZE_CS_SM10_for pub | 0-00-2 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Brochure_DEU_DE_IN-RFI020_for pub | v00.2 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Brochure_AUT_DE_IN-RFI010_for pub | v00.2 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Brochure_NLD_NL_SM11_for pub | v1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Brochure_SWE_SV_IN-RFI012_for pub | v00-2 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Summary PIS_IRL_EN_Access_IN-RFI001_not pub | 00 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Summary PIS_IRL_EN_IN_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_FBR consent_CZE_CS_IN_for pub | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_FBR consent_DEU_DE_IN-RFI020_for pub | v0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_FBR consent_DNK_DA_IN_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_FBR consent_ESP_ES_IN_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_FBR consent_FRA_FR_IN-RFI003_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_FBR consent_GRC_EL_IN_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_FBR consent_NLD_NL_IN-RFI014_for pub | v0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_FBR consent_NOR_NN_IN-RFI025_for pub | v00 |
| Subject information and informed consent form (for publication) | L1_ICF_FBR consent_POL_PL_IN_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_FBR consent_SWE_SV_IN_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent adult_GRC_EL_IN_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_AUT_DE_IN-RFI018_for pub | v0.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_CZE_CS_IN-RFI005_for pub | 2R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_DEU_DE_IN-RFI020_for pub | v0.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_DNK_DA_IN-RFI021_for pub | 00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_ESP_ES_IN-RFI009_for pub | 00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_FRA_FR_IN-RFI003_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_IRL_EN_IN-RFI024_for pub | 00c |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_ITA_IT_IN-RFI004_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_NLD_NL_IN-RFI014_for pub | v0.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_NOR_NN_IN-RFI025_for pub | v00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_POL_PL_IN-RFI017_for pub | 00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_SWE_SV_IN-RFI012_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main data privacy_ITA_IT_IN_for pub | 10FEB2025 |
| Subject information and informed consent form (for publication) | L1_ICF_Main GDPR_CZE_CS_for pub | 3-0 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_add crossborder_DEU_DE_IN-RFI020_for pub | v0.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_DILI sample_ITA_IT_IN_for pub | 10FEB2025 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_Greenphire adults_CZE_CS_IN_for pub | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_Greenphire adults_GRC_EL_IN_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_Greenphire adults_IRL_EN_IN_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_Greenphire adults_SWE_SV_IN_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_infant follow-up_FRA_FR_IN-RFI003_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnant partner data privacy_ITA_IT_IN-RFI004_for pub | 14APR2025 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnant partner_DEU_DE_IN-RFI020_for pub | v0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnant partner_ESP_ES_IN_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnant partner_FRA_FR_IN-RFI003_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnant partner_ITA_IT_IN-RFI004_for pub | 14APR2025 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_right not to know_DNK_DA_IN_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_Patient ID Card_CZE_CS_for pub | 1.0 00 1.2 |
| Subject information and informed consent form (for publication) | L2_Patient advocacy_AUT_DE_IN_for pub | 00 |
| Subject information and informed consent form (for publication) | L2_Patient contacts per site_0170_AUT_DE_IN_for pub | 20JAN2025R |
| Subject information and informed consent form (for publication) | L2_Patient contacts per site_0171_AUT_DE_IN_for pub | 23JAN2025R |
| Subject information and informed consent form (for publication) | L2_Patient contacts per site_0172_AUT_DE_IN-RFI010_for pub | 13MAY2025R |
| Subject information and informed consent form (for publication) | L2_Patient emergency card_CZE_CS_IN_for pub | 1 |
| Subject information and informed consent form (for publication) | L2_Patient emergency card_FRA_FR_IN-RFI003_for pub | 01MAY2024 |
| Subject information and informed consent form (for publication) | L2_Patient instructions_AUT_DE_IN_for pub | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient instructions_CZE_CS_IN_for pub | 1 |
| Subject information and informed consent form (for publication) | L2_Patient instructions_FRA_FR_IN-RFI003_for pub_Version 01MAY2024_01MAY2024 | 01MAY2024 |
| Subject information and informed consent form (for publication) | L2_Patient instructions_Patient guide_CZE_CS_IN_for pub | 1 |
| Subject information and informed consent form (for publication) | L2_Patient instructions_Pocket guide_CZE_CS_IN_for pub | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC RSI_Docetaxel_IN_for pub | 02Aug2023 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC RSI_Prednesol_IN_for pub | 12Apr2024 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC RSI_Prednisone_IN_for pub | 01Mar2022 |
| Synopsis of the protocol (for publication) | D1_PPLS_2024-517423-40_CZE_CS_IN_for pub | 1 |
| Synopsis of the protocol (for publication) | D1_PPLS_2024-517423-40_ESP_ES_IN_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2024-517423-40_FRA_FR_IN_for pub | 15JAN2025 |
| Synopsis of the protocol (for publication) | D1_PPLS_2024-517423-40_GRC_EL_IN_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2024-517423-40_IN_MK-2400-001-00_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2024-517423-40_IRL_EN_IN_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2024-517423-40_ITA_IT_IN_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2024-517423-40_NLD_NL_IN_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2024-517423-40_NOR_NN_IN_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2024-517423-40_POL_PL_IN_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2024-517423-40_SWE_SV_IN_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Scientific Synopsis_2024-517423-40_AUT_DE_IN_for pub | 0.00R |
| Synopsis of the protocol (for publication) | D1_Protocol Scientific Synopsis_2024-517423-40_CZE_CS_IN_for pub | 1R |
Application history
11 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-02-19 | Denmark | Acceptable 2025-06-10
|
2025-06-10 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-07-13 | Acceptable 2025-06-10
|
2025-07-13 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-07-20 | Acceptable | 2025-08-26 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-07-20 | Acceptable | 2025-07-31 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-11 | 2025-07-20 | Acceptable | 2025-08-28 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-10 | 2025-07-21 | Acceptable | 2025-09-08 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-12 | 2025-07-23 | Acceptable | 2025-08-22 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-07-24 | Acceptable | 2025-08-07 | |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-09-11 | Denmark | Acceptable | 2025-09-11 |
| 10 | SUBSTANTIAL MODIFICATION | SM-13 | 2025-11-26 | Acceptable | 2025-12-05 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-14 | 2025-12-18 | Denmark | Acceptable 2026-03-27
|
2026-03-27 |