Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
647
Countries
14
Sites
121
Advanced Non-Small Cell Lung Cancer
This Phase 3 study will evaluate the efficacy of the investigational agent MRTX849 versus docetaxel in patients who have been previously treated for metastatic NSCLC with a KRAS G12C mutation.
Key facts
- Sponsor
- Mirati Therapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 23 Dec 2020 → ongoing
- Decision date (initial)
- 2024-07-16
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Mirati Therapeutics, Inc.
External identifiers
- EU CT number
- 2023-507263-19-00
- EudraCT number
- 2020-003645-11
- ClinicalTrials.gov
- NCT04685135
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Safety, Pharmacokinetic, Efficacy
This Phase 3 study will evaluate the efficacy of the investigational agent MRTX849 versus docetaxel in patients who have been previously treated for metastatic NSCLC with a KRAS G12C mutation.
Secondary objectives 4
- Evaluate secondary efficacy endpoints in the study population.
- Evaluate the safety and tolerability in the study population.
- Evaluate the pharmacokinetics of MRTX849 administered in the study population.
- Evaluate health-related quality of life and cancer-specific symptoms in the study population.
Conditions and MedDRA coding
Advanced Non-Small Cell Lung Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10061873 | Non-small cell lung cancer | 100000004864 |
Regulatory references
- Scientific advice from competent authorities
- Danish Medicines Agency
- Plan to share IPD
- No
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Histologically or cytologically confirmed diagnosis of NSCLC with KRAS G12C mutation.
- Candidacy to receive treatment with docetaxel.
- Crossover Inclusion Criteria: Evidence of RECIST 1.1 defined disease progression on docetaxel per BICR
- Crossover Inclusion Criteria: ECOG performance status 0 - 2.
Exclusion criteria 3
- Prior treatment with an agent targeting KRAS G12C (e.g., AMG 510, sotorasib).
- Active brain metastases
- Crossover Exclusion Criteria: Receipt of any other systemic anti-cancer therapy after last administration of docetaxel on the study.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Progression-free Survival (PFS) Defined as time from randomization until disease progression or death from any cause, whichever occurs first.
Secondary endpoints 4
- Secondary efficacy endpoints:- Overall Survival (OS)− Objective Response Rate (ORR),− Duration of Response (DOR), and− 1-Year Survival Rate.
- Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of adverse events (AEs), laboratory abnormalities, and number of patients discontinuing study treatment due to an adverse event.
- Population PK parameters of MRTX849.
- Patient Reported Outcome (PRO) scores using the following:− Lung Cancer Symptom Scale (LCSS), and− European Quality of Life Five Dimensions Questionnaire(EQ-5D-5L).
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD8665001 · Product
- Active substance
- Adagrasib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1200 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 Day(s)
- Authorisation status
- Not Authorised
- ATC code
- NOTASSIGN — -
- MA holder
- MIRATI THERAPEUTICS INC
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 6
SUB12492MIG · Substance
- Active substance
- Docetaxel
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 75 mg/m2 milligram(s)/square meter
- Max total dose
- 9999 mg/m2 milligram(s)/square meter
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
TAXOTERE 20 mg/1 ml concentrate for solution for infusion
PRD479192 · Product
- Active substance
- Docetaxel
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 75 mg/m2 milligram(s)/square meter
- Max total dose
- 9999 mg/m2 milligram(s)/square meter
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01CD02 — DOCETAXEL
- Marketing authorisation
- EU/1/95/002/003
- MA holder
- SANOFI WINTHROP INDUSTRIE
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
TAXOTERE 80 mg/4 ml concentrate for solution for infusion
PRD479238 · Product
- Active substance
- Docetaxel
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 75 mg/m2 milligram(s)/square meter
- Max total dose
- 9999 mg/m2 milligram(s)/square meter
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01CD02 — DOCETAXEL
- Marketing authorisation
- EU/1/95/002/004
- MA holder
- SANOFI WINTHROP INDUSTRIE
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
TAXOTERE 20 mg/0.5 ml concentrate and solvent for solution for infusion
PRD586554 · Product
- Active substance
- Docetaxel
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 75 mg/m2 milligram(s)/square meter
- Max total dose
- 9999 mg/m2 milligram(s)/square meter
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01CD02 — DOCETAXEL
- Marketing authorisation
- EU/1/95/002/001
- MA holder
- SANOFI WINTHROP INDUSTRIE
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB12492MIG · Substance
- Active substance
- Docetaxel
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 75 mg/m2 milligram(s)/square meter
- Max total dose
- 9999 mg/m2 milligram(s)/square meter
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB12492MIG · Substance
- Active substance
- Docetaxel
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 75 mg/m2 milligram(s)/square meter
- Max total dose
- 999 mg/m2 milligram(s)/square meter
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Mirati Therapeutics Inc.
- Sponsor organisation
- Mirati Therapeutics Inc.
- Address
- Route 206, Province Line Road Province Line Road
- City
- Princeton
- Postcode
- 08543
- Country
- United States
Scientific contact point
- Organisation
- Mirati Therapeutics Inc.
- Contact name
- Mirati Study Locator
Public contact point
- Organisation
- Mirati Therapeutics Inc.
- Contact name
- Mirati Study Locator
Third parties 13
| Organisation | City, country | Duties |
|---|---|---|
| Labcorp Early Development Laboratories Inc. ORG-100012865
|
Madison, United States | Other |
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Other |
| Bioclinica Inc. ORG-100033079
|
Princeton, United States | Other |
| Resolution Bioscience Inc. ORG-100048922
|
Kirkland, United States | Other |
| Azenta Germany GmbH ORG-100022621
|
Griesheim, Germany | Other |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | On site monitoring, Code 12, Code 2, Code 5, Code 8, Code 9 |
| Scout Clinical ORG-100042228
|
Dallas, United States | Other |
| Quipment ORG-100043496
|
Nancy, France | Other |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Other |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | E-data capture |
| Pharmaceutical Product Development LLC ORG-100016999
|
Wilmington, United States | Other |
| Endpoint Clinical Inc. ORG-100040567
|
Wakefield, United States | Interactive response technologies (IRT) |
| PRA Hellas CRO A.E. ORG-100048208
|
Nea Ionia, Greece | On site monitoring, Other, Code 2, Code 9 |
Locations
14 EU/EEA countries · 121 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ended | 7 | 1 |
| Belgium | Ongoing, recruitment ended | 12 | 7 |
| Czechia | Ended | 6 | 1 |
| France | Ongoing, recruitment ended | 150 | 22 |
| Germany | Ongoing, recruitment ended | 38 | 6 |
| Greece | Ongoing, recruitment ended | 19 | 7 |
| Hungary | Ended | 30 | 1 |
| Ireland | Ended | 14 | 4 |
| Italy | Ongoing, recruitment ended | 125 | 20 |
| Netherlands | Ongoing, recruitment ended | 8 | 4 |
| Poland | Ongoing, recruitment ended | 22 | 6 |
| Portugal | Ongoing, recruitment ended | 28 | 7 |
| Romania | Ended | 18 | 11 |
| Spain | Ongoing, recruitment ended | 80 | 24 |
| Rest of world
Puerto Rico, Singapore, Korea, Republic of, Switzerland, China, Australia, United Kingdom, Hong Kong, Russian Federation, United States
|
— | 90 | — |
Investigational sites
Landeskrankenanstalten-Betriebsgesellschaft Kabeg
NA, Feschnigstrasse 11, Klagenfurt,09.Bez.:Annabichl, Klagenfurt Am Woerthersee
Az Maria Middelares Gent
Pulmonology, Buitenring-Sint-Denijs 30, 9000, Gent
Jessa Ziekenhuis
Pulmonology, Salvatorstraat 20, 3500, Hasselt
Grand Hopital De Charleroi
Medical Oncology, Rue Marguerite Depasse 6, 6060, Charleroi
Antwerp University Hospital
Pulmonology, Drie Eikenstraat 655, 2650, Edegem
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Pulmonology, Avenue Docteur Gaston Therasse 1, 5530, Yvoir
UZ Brussel
Medical Oncology, Laarbeeklaan 101, 1090, Jette
Algemeen Ziekenhuis Delta
Pulmonology, Oncology, Deltalaan 1, 8800, Roeselare
University Hospital Olomouc
Klinika plicních nemocí a tuberkulózy, Zdravotniku 248/7, 779 00, Olomouc
Centre Hospitalier Regional De Marseille
Oncologie Multidisciplinaire & Innovations Thérapeutiques, 265 Chemin Des Bourrely, 13015, Marseille
Groupe Hospitalier De La Region De Mulhouse Et Sud Alsace
Service Pneumologie, 20 Avenue Du Docteur Rene Laennec, 68100, Mulhouse
Hopital Cardiologique
Pneumology and Thoracic Oncology, Boulevard Du Professeur Jules Leclercq, 59037, Lille Cedex
Centre Hospitalier Universitaire Grenoble Alpes
Pneumologie, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9
Hospices Civils De Lyon
Service de Pneumologie, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
Centre Antoine Lacassagne
Oncologie Médicale, 33 Avenue De Valombrose, 06189, Nice Cedex 2
Institut De Cancerologie De L Ouest
Service d'oncologie médicale, Boulevard Jacques Monod, 44805, Saint-Herblain Cedex
Centre Hospitalier Et Universitaire De Limoges
Unité d’Oncologie Thoracique, 2 Avenue Martin Luther King, 87042, Limoges Cedex 1
Hospices Civils De Lyon
Service de Pneumologie, 59 Boulevard Pinel, 69500, Bron
Centr Georges Francois Leclerc
Unité Fonctionnelle Oncologie, 1 Rue Professeur Marion, 21000, Dijon
Centre Hospitalier Universitaire De Montpellier
Service Pneumologie, Allergologie et oncologie thoracique, 191 Avenue Du Doyen Gaston Giraud, 34295, Montpellier Cedex 5
Centre Hospitalier Universitaire De Caen Normandie
Service de Pneumologie, Avenue De La Cote De Nacre, 14000, Caen
Centre Hospitalier Intercommunal De Cornouaille
Thoracic Oncology, 14 Avenue Yves Thepot, Bp 31757, Quimper Cedex
Centre Hospitalier Intercommunal Creteil
Service de Pneumologie, 40 Avenue De Verdun, 94000, Creteil
Les Hopitaux Universitaires De Strasbourg
Pneumology, 1 Place De L Hopital, Cs 80426, Strasbourg Cedex
Institut Gustave Roussy
Pneumology, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Hospitalier Regional Universitaire De Tours
Service de Pneumologie, 2 Boulevard Tonnelle, 37044, Tours Cedex 9
Centre Hospitalier Regional Et Universitaire De Brest
Institut de cancérologie, Boulevard Tanguy Prigent, 29200, Brest
Hospices Civils De Lyon
Service de Pneumologie, 103 Grande Rue De La Croix Rousse, 69317, Lyon Cedex 04
Les Hopitaux Nord-Ouest
Service de Pneumologie, Plateau D Ouilly, Cs 80436 Gleize, Villefranche Sur Saone Cedex
Centre Francois Baclesse
Respiratory Diseases and Thoracic Oncology, 3 Avenue Du General Harris, Cs 45026, Caen Cedex 5
Centre Regional Lutte Contre Le Cancer
Oncologie médicale, Batiment Icans, 17 Rue Albert Calmette, Strasbourg
Muenchen Klinik gGmbH
Klinik für Pneumologie und Pneumologische Onkologie, Englschalkinger Strasse 77, Bogenhausen, Munich
Universitaetsklinikum Giessen und Marburg GmbH
Medizinische Klinik IV Organonkologie, Klinikstrasse 33, 35392, Giessen
Sana Klinikum Offenbach GmbH
Medizinische Klinik IV für Hämatologie und internistische Onkologie, Starkenburgring 66, 63069, Offenbach Am Main
Zentralklinik Bad Berka GmbH
Klinik für Internistische Onkologie und Hämatologie, Robert-Koch-Allee 9, 99437, Bad Berka
SLK-Kliniken Heilbronn GmbH
SLK-Kliniken - Fachklinik Löwenstein, Geisshoelzle 62, Hirrweiler, Loewenstein
KEM I Evang. Kliniken Essen-Mitte gGmbH
Klinik für Internistische Onkologie/Hämatologie mit Integrierter Palliativmedizin, Henricistrasse 92, Huttrop, Essen
Henry Dunant Hospital Center
4th Oncology Department, 107 Mesogeion Avenue, 115 26, Athens
Metropolitan Hospital
4th Oncology Department, Ethnarchi Makariou 11, 185 47, Pireas
Athens Medical Center S.A.
Oncology Department, Pylea, Asklipiou 10, Thessaloniki
General Oncological Hospital Of Kifissia Agioi Anargyroi
Department of Medical Oncology, Timio Stavrou And 14 Noufaron, 145 64, Kifissia
General University Hospital Of Larissa
Oncology Clinic-1st Internal Medicine Division, P. O. Box 1425, 411 10, Larissa
Thoracic General Hospital Of Athens I Sotiria
3rd Internal Medicine Department of Athens University-Oncology Unit, Messogion Avenue 152, 115 27, Athens
Geniko Nosokomeio Thessalonikis George Papanikolaou
University Pulmonary Department, Exochi, 570 10, Thessaloniki
Semmelweis University
Pulmonológiai Klinika, Tomo Utca 25-29, 1083, Budapest VIII
St James's Hospital
Oncology, James's Street, D08 NHY1, Dublin 8
University Hospital Limerick
Oncology, Saint Nessan's Road, V94 F858, Limerick
Tallaght University Hospital
Oncology, Tallaght, D24 NR0A, Dublin 24
Beaumont Hospital
Oncology, Beaumont Road, Beaumont, Dublin 9
Centro Di Riferimento Oncologico Di Aviano
UO Oncologia Medica, Via Franco Gallini 2, 33081, Aviano
Careggi University Hospital
SODc Oncologia Medica e Clinica, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
AORN San Giuseppe Moscati Avellino
U.O. di Oncologia Medica, Contrada Amoretta, 83100, Avellino
Azienda Sanitaria Territoriale Di Pesaro E Urbino
Onco-Hematology, Piazzale Carlo Cinelli N 4, 61121, Pesaro
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Thoraco-Pulmonary Department, Via Mariano Semmola 52, 80131, Naples
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
S.C. Oncologia Medica, Via Santa Sofia 78, 95123, Catania
Istituto Tumori Bari Giovanni Paolo II
UO Oncologia Medica Per la Patologia Toracica, Viale Orazio Flacco 65, 70124, Bari
ARNAS Garibaldi Di Catania
Oncologia Medica, Piazza Santa Maria Di Gesu, 95123, Catania
Azienda Ospedaliero Universitaria Parma
UO Oncologia Medica, Viale Antonio Gramsci 14, 43126, Parma
Hospital Santa Maria Della Misericordia
S.C. Oncologia Medica, Piazzale Giorgio Menghini 1, 06129, Perugia
Ospedale Vito Fazzi Lecce
U.O. Oncologia Medica, Piazza Filippo Muratore 1, 73100, Lecce
Azienda Sociosanitaria 3
SSD Oncologia, PO Villa Scassi, Via Agostino Bertani 4, 16125, Genoa
Istituto Europeo Di Oncologia S.r.l.
Thoracic Oncology Division, Via Giuseppe Ripamonti 435, 20141, Milan
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
UO Oncologia Medica, Piazzale Spedali Civili 1, 25123, Brescia
Azienda Ospedaliero-Universitaria Maggiore Della Carita
SCDU Oncologia, Corso Giuseppe Mazzini 18, 28100, Novara
IRCCS Ospedale Policlinico San Martino
S.C. Oncologia Medica 2, Largo Rosanna Benzi 10, 16132, Genoa
Istituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia IRCCS
Department of Oncology, Strada Provinciale 142 Orba Km 3,95, 10060, Candiolo
Azienda Ospedaliero-Universitaria Ss Antonio E Biagio E Cesare Arrigo
SC Oncologia, Via Venezia 16, 15121, Alexandria
I.F.O. Istituti Fisioterapici Ospitalieri
UO Oncologia Medica 2, Via Elio Chianesi 34, 00144, Rome
Fondazione IRCCS Istituto Nazionale Dei Tumori
SC Oncologia Medica 1, Via Giacomo Venezian 1, 20133, Milan
Radboud universitair medisch centrum / RADBOUDUMC
Department Respiratory Diseases, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
St. Antonius Ziekenhuis
Pneumology, Soestwetering 1, 3543 AZ, Utrecht
Amphia Hospital
Pneumology, Molengracht 21, 4818 CK, Breda
Academisch Ziekenhuis Maastricht
Department of Respiratory Medicine, P Debyelaan 25, 6229 HX, Maastricht
Ms Pneumed Janusz Milanowski Katarzyna Szmygin-Milanowska sp.j.
NA, Polnocna 18 Lok U1, 20-064, Lublin
Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy
Pulmonary disease department, Ul. Gabriela Narutowicza 80, 05-400, Otwock
Mruk-Med I Sp. z o.o.
NA, Ul. Gen. Mariana Langiewicza 61, 35-021, Rzeszow
Pratia S.A.
NA, Ul. Poznanska 14, 60-185, Skorzewo
Specjalistyczna Praktyka Lekarska Slawomir Mandziuk
Oncology, ul. Chodzki 17/2, 20-093, Lublin
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Oncology, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Unidade Local De Saude Do Alto Ave E.P.E.
Gabinete de Investigação Clínica, Rua Dos Cuteleiros De Guimaraes, 4835-044, Guimaraes
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.
Serviço de Pneumologia, Rua Professor Lima Basto, 1099-023, Lisbon
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Unidade de Investigação Clínica, Rua Dr. Antonio Bernardino De Almeida, 4200-072, Porto
Unidade Local De Saude De Santo Antonio E.P.E.
Serviço de Investigação Clínica, Largo Professor Abel Salazar, 4050-011, Porto
Hospital Cuf Descobertas S.A.
-, Rua Mario Botas 1, 1998-018, Lisbon
Instituto Portugues De Oncologia De Coimbra Francisco Gentil E.P.E.
Serviço de Oncologia Médica - Investigação, Avenida Doutor Bissaya Barreto 98, 3000-075, Coimbra
Unidade Local De Saude De Coimbra E.P.E.
Hospital de dia de Oncologia, Praceta Professor Mota Pinto, 3004-561, Coimbra
Medisprof S.R.L.
Oncologie Medicala, Bulevardul Muncii 96, 400641, Cluj-Napoca
Centrul De Oncologie-Euroclinic S.R.L.
Oncologie Medicala, Strada Conta Vasile 2, 700106, Iasi
Oncocenter Oncologie Clinica S.R.L.
Oncologie Medicala, Strada Garii 1a, 300166, Timisoara
Oncolab S.R.L.
Oncologie Medicala, Strada Bujorului 7, 200385, Craiova
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
Oncologie Medicala, Soseaua Fundeni 252, 022328, Bucharest
Ovidius Clinical Hospital S.R.L.
Oncologie Medicala, Dn 2a Km 202 880, 905900, Ovidiu
Hyperclinica MedLife Policlinica de Diagnostic Rapid Turnului Brasov
Oncologie, Strada Turnului 5A, 500152, Brasov
Oncomed S.R.L.
Oncologie Medicala, Strada Porumbescu Ciprian 57-59, 300239, Timisoara
Centrul De Oncologie SF Nectarie S.R.L.
Oncologie Medicala, Strada Caracal Nr 109, 200542, Craiova
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Oncologie Medicala, Strada Republicii 34-36, 400015, Cluj-Napoca
Spitalul Judetean De Urgenta Dr. Constantin Opris Baia Mare
Oncologie Medicala, Strada Cosbuc George Nr 31, 430031, Baia Mare
Institut Catala D'oncologia
arly Drug Development Group - Medical Oncology Department, Carretera Canyet S/n, 08916, Badalona
Hospital Universitario Marques De Valdecilla
Oncology, Avenida Valdecilla Sn, 39008, Santander
Institut Catala D'oncologia
Medical Oncology Department, Avinguda De Franca S/n, 17007, Girona
Hospital Universitari Dexeus Grupo Quironsalud
Medical Oncology, Calle De Sabino Arana 5-19, 08028, Barcelona
Complejo Hospitalario Universitario Insular Materno Infantil
Medical Oncology, Autovia Del Sur S/n, 35017, Las Palmas De Gran Canaria
Clinica Universidad De Navarra
Oncology, Avenue Pio XII 36, 31008, Pamplona
Hospital Universitario Y Politecnico La Fe
Thoracic Oncology Unit – Medical Oncology Department, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario Ramon Y Cajal
Head of the Department – Oncology Department, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Beata Maria Ana
Oncology, Calle Del Doctor Esquerdo No. 83, 28007, Madrid
Hospital Universitario De Leon
Oncology Department, Calle Altos De Nava S/n, 24071, Leon
Hospital General Universitario Dr. Balmis
Oncology Department, Avinguda Del Pintor Baeza 12, 03010, Alicante
University Hospital Son Espases
Oncology, Carretera Valldemossa 79, 07120, Palma
Complexo Hospitalario Universitario A Coruna
Oncology, Lugar Jubias De Arriba 84, 15006, A Coruna
Hospital Universitario Virgen De Las Nieves
Internal Medicine, Avenida De Las Fuerzas Armadas 2, 18014, Granada
Clinica Universidad De Navarra
Oncology, Calle Marquesado De Santa Marta 1, 28027, Madrid
Hospital Universitario Regional De Malaga
Oncology, Avenida De Carlos De Haya Sn, 29010, Malaga
Hospital Clinic De Barcelona
Oncology, Calle Villarroel 170, 08036, Barcelona
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Clinico San Carlos
Oncology, Calle Del Profesor Martin Lagos Sn, 28040, Madrid
Hospital Universitario Puerta De Hierro De Majadahonda
Oncology, Calle De Manuel De Falla 1, 28222, Majadahonda
Hospital Universitario De Cruces
Oncology, Cruces Plaza S/n, 48903, Barakaldo
University Hospital Virgen Del Rocio S.L.
Oncology Department, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Clinico Universitario Lozano Blesa
Oncology, Avenida De San Juan Bosco 15, 50009, Zaragoza
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 | 2020-12-23 | 2025-02-11 | 2022-05-03 | 2023-10-03 | |
| Belgium | 2022-01-12 | 2023-01-17 | 2023-10-10 | ||
| Czechia | 2022-01-18 | 2024-04-18 | 2022-07-07 | 2023-05-31 | |
| France | 2021-09-27 | 2021-10-25 | 2023-10-11 | ||
| Germany | 2021-12-13 | 2022-08-12 | 2023-10-10 | ||
| Greece | 2021-09-28 | 2021-12-16 | 2023-09-11 | ||
| Hungary | 2021-09-28 | 2025-12-24 | 2021-12-28 | 2023-03-30 | |
| Ireland | 2021-11-24 | 2025-11-30 | 2022-04-20 | 2023-08-21 | |
| Italy | 2021-10-12 | 2022-02-07 | 2023-10-11 | ||
| Netherlands | 2023-03-22 | 2023-05-26 | 2023-10-05 | ||
| Poland | 2021-08-26 | 2021-11-16 | 2023-10-11 | ||
| Portugal | 2021-12-02 | 2022-01-25 | 2023-09-28 | ||
| Romania | 2023-02-21 | 2024-06-06 | 2023-03-22 | 2023-10-09 | |
| Spain | 2021-09-23 | 2021-11-17 | 2023-10-11 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 165 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Clinical study report (for publication) | 2023-507263-19-00 -ca239-0013-primary-csr-14-2-tables-redacted | 1 |
| Clinical study report (for publication) | 2023-507263-19-00 -ca239-0013-primary-csr-14-2-figures-redacted | 1 |
| Clinical study report (for publication) | 2023-507263-19-00 -ca239-0013-primary-csr-14-3-1-tables-redacted | 1 |
| Clinical study report (for publication) | 2023-507263-19-00 -ca239-0013-primary-csr-14-3-2-tables-redacted | 1 |
| Clinical study report (for publication) | 2023-507263-19-00 -ca239-0013-primary-csr-14-3-3-tables-redacted | 1 |
| Clinical study report (for publication) | 2023-507263-19-00 -ca239-0013-primary-csr-14-3-5-figures-redacted | 1 |
| Clinical study report (for publication) | 2023-507263-19-00 -ca239-0013-primary-csr-14-3-5-tables-redacted | 1 |
| Clinical study report (for publication) | 2023-507263-19-00 -ca239-0013-primary-csr-14-3-6-tables-redacted | 1 |
| Clinical study report (for publication) | 2023-507263-19-00 -ca239-0013-primary-csr-14-3-8-tables-redacted | 1 |
| Clinical study report (for publication) | 2023-507263-19-00 -ca239-0013-primary-csr-14-3-9-narratives_Part2-redacted | 1 |
| Clinical study report (for publication) | 2023-507263-19-00 -ca239-0013-primary-csr-14-3-9-narratives_Part3-redacted | 1 |
| Clinical study report (for publication) | 2023-507263-19-00 -ca239-0013-primary-csr-16-1-1-protocol-info-redacted | 1 |
| Clinical study report (for publication) | 2023-507263-19-00 -ca239-0013-primary-csr-16-1-2-sam-crf-redacted | 1 |
| Clinical study report (for publication) | 2023-507263-19-00 -ca239-0013-primary-csr-16-1-9-stat-info-redacted | 1 |
| Clinical study report (for publication) | 2023-507263-19-00 -ca239-0013-primary-csr-report-body-redacted | 1 |
| Clinical study report (for publication) | 2023-507263-19-00 -ca239-0013-primary-csr-synopsis-redacted | 1 |
| Clinical study report (for publication) | 2023-507263-19-00 -ca239-0013-primary-csr-14-1-tables-redacted | 1 |
| Clinical study report (for publication) | 2023-507263-19-00 -ca239-0013-primary-csr-14-3-9-narratives_Part1-redacted | 1 |
| Protocol (for publication) | D1_Protocol_2023-507263-19_Greek_redacted | 7.4 |
| Protocol (for publication) | D1_Protocol_2023-507263-19-00_redacted | 7.5 EU |
| Protocol (for publication) | D4_Patient facing documents questionnaire - For publication | N/A |
| Recruitment arrangements (for publication) | K_AT_Recruitment Arrangements_Placeholder document | 1 |
| Recruitment arrangements (for publication) | K_BE_Recruitment Arrangements_Placeholder Document | 1 |
| Recruitment arrangements (for publication) | K_DE_Recruitment Arrangement_Placeholder document | 1 |
| Recruitment arrangements (for publication) | K_EL_Recruitment Arrangements_Placeholder document | 1 |
| Recruitment arrangements (for publication) | K_ES_Recruitment Arrangement_Placeholder document | 1 |
| Recruitment arrangements (for publication) | K_FR_Recruitment Arrangement_Placeholder document | 1 |
| Recruitment arrangements (for publication) | K_HU_Recruitment Arrangements_Placeholder document | 1 |
| Recruitment arrangements (for publication) | K_IE_Recruitment Arrangement_Placeholder document | 1 |
| Recruitment arrangements (for publication) | K_IT_Recruitment arrangements_Placeholder document | 1 |
| Recruitment arrangements (for publication) | K_NL_Recruitment Arrangements_Placeholder document | 1 |
| Recruitment arrangements (for publication) | K_PL_Recruitment Arrangements_Placeholder document | 1 |
| Recruitment arrangements (for publication) | K_PT_Recruitment Arrangements_Placeholder document | 1 |
| Recruitment arrangements (for publication) | K1_NL_Recruitment Procedure | 1 |
| Subject information and informed consent form (for publication) | L1_AT_SIS-ICF_Adult Main Addendum 1_German | 1.0 |
| Subject information and informed consent form (for publication) | L1_AT_SIS-ICF_Adult Main_German_redacted | 10.0 |
| Subject information and informed consent form (for publication) | L1_AT_SIS-ICF_Continuation Post disease progression_German | 9.0 |
| Subject information and informed consent form (for publication) | L1_AT_SIS-ICF_Crossover_German | 4.0 |
| Subject information and informed consent form (for publication) | L1_AT_SIS-ICF_Discordance_German | 8.0 |
| Subject information and informed consent form (for publication) | L1_AT_SIS-ICF_Exploratory Research_German_redacted | 7.1 |
| Subject information and informed consent form (for publication) | L1_AT_SIS-ICF_List of contact details of sites for the ICF_Placeholder document | 2 |
| Subject information and informed consent form (for publication) | L1_AT_SIS-ICF_Main_German_redacted | 11.0 |
| Subject information and informed consent form (for publication) | L1_AT_SIS-ICF_Optional Tumour and Blood Sample_German_redacted | 7.1 |
| Subject information and informed consent form (for publication) | L1_AT_SIS-ICF_Partner Pregnancy_German_redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_AT_SIS-ICF_Pregnancy_German_redacted | 7.1 |
| Subject information and informed consent form (for publication) | L1_AT_SIS-ICF_Prescreening_German_redacted | 9.0 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Continuation Discordance_Dutch_redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Continuation Discordance_French_redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Continuation Post Disease Progr_Dutch_redacted | 9.1 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Continuation Post Disease Progr_French_redacted | 9.1 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Crossover_Dutch_redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Crossover_French_redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Main Addendum_Dutch_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Main Addendum_French_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Main_Dutch_redacted | 11.0 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Main_French_redacted | 11.0 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Pre-Screening_Dutch_redacted | 9.0 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Pre-Screening_French_redacted | 9.0 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Pregnancy Follow-Up_Dutch_redacted | 7.1 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Pregnancy Follow-Up_French_redacted | 7.1 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Pregnant Partner_Dutch_redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Pregnant Partner_French_redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_DE_SIS-ICF_Continuation Discordance_German | 8.0 |
| Subject information and informed consent form (for publication) | L1_DE_SIS-ICF_Continuation Post disease progression_German | 9.1 |
| Subject information and informed consent form (for publication) | L1_DE_SIS-ICF_Crossover_German | 4.1 |
| Subject information and informed consent form (for publication) | L1_DE_SIS-ICF_Main Addendum_German | 1.0 |
| Subject information and informed consent form (for publication) | L1_DE_SIS-ICF_Main_German_redacted | 11.0 |
| Subject information and informed consent form (for publication) | L1_DE_SIS-ICF_Partner Pregnancy_German_redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_DE_SIS-ICF_Pregnancy_German | 7.1 |
| Subject information and informed consent form (for publication) | L1_DE_SIS-ICF_Prescreening_German_redacted | 9.0 |
| Subject information and informed consent form (for publication) | L1_EL_SIS-ICF Addendum_Greek | 1.0 |
| Subject information and informed consent form (for publication) | L1_EL_SIS-ICF_Continuation-Discordance_Greek | 8.0 |
| Subject information and informed consent form (for publication) | L1_EL_SIS-ICF_Continuation-Post Disease Progression_Greek | 9.0 |
| Subject information and informed consent form (for publication) | L1_EL_SIS-ICF_Crossover_Greek | 1.0 |
| Subject information and informed consent form (for publication) | L1_EL_SIS-ICF_Main_Greek_redacted | 10.1 |
| Subject information and informed consent form (for publication) | L1_EL_SIS-ICF_Pregnancy_Greek | 8.1 |
| Subject information and informed consent form (for publication) | L1_EL_SIS-ICF_Prescreening_Greek_redacted | 9.0 |
| Subject information and informed consent form (for publication) | L1_ES_SIS-ICF_Annex_Spanish | 1.0 |
| Subject information and informed consent form (for publication) | L1_ES_SIS-ICF_Continuation Discordance_Spanish | 8.0 |
| Subject information and informed consent form (for publication) | L1_ES_SIS-ICF_Continuation Post Disease Progression_Spanish | 9.0 |
| Subject information and informed consent form (for publication) | L1_ES_SIS-ICF_Crossover_Spanish | 3.0 |
| Subject information and informed consent form (for publication) | L1_ES_SIS-ICF_Data Protection_Spanish_redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_ES_SIS-ICF_Main_Spanish | 11.0 |
| Subject information and informed consent form (for publication) | L1_ES_SIS-ICF_Pregnancy_Spanish | 7.0 |
| Subject information and informed consent form (for publication) | L1_ES_SIS-ICF_Pregnant Partner_Spanish_redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_ES_SIS-ICF_Prescreening_Spanish | 7.0 |
| Subject information and informed consent form (for publication) | L1_FR_SIS-ICF_Crossover_French | 4.0 |
| Subject information and informed consent form (for publication) | L1_FR_SIS-ICF_Discordance_French | 7.0 |
| Subject information and informed consent form (for publication) | L1_FR_SIS-ICF_Main Addendum_French | 1.0 |
| Subject information and informed consent form (for publication) | L1_FR_SIS-ICF_Main_French_redacted | 11.0 |
| Subject information and informed consent form (for publication) | L1_FR_SIS-ICF_Pregnancy Partner_French_redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_FR_SIS-ICF_Pregnancy_French_redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_FR_SIS-ICF_Prescreening_French_redacted | 9.0 |
| Subject information and informed consent form (for publication) | L1_FR_SIS-ICF_Progression_French | 8.0 |
| Subject information and informed consent form (for publication) | L1_FR_SIS-ICF_Scout Clinical_French_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_HU_ICF_Addendum to Main_Hungarian | 1.0 |
| Subject information and informed consent form (for publication) | L1_HU_ICF_Continuation Discordance_Hungarian | 4.0 |
| Subject information and informed consent form (for publication) | L1_HU_ICF_Continuation Post disease progression_Hungarian | 6.0 |
| Subject information and informed consent form (for publication) | L1_HU_ICF_Crossover_Hungarian | 3.0 |
| Subject information and informed consent form (for publication) | L1_HU_ICF_Genetic_Hungarian | 3.0 |
| Subject information and informed consent form (for publication) | L1_HU_ICF_Main_Hungarian | 6.0 |
| Subject information and informed consent form (for publication) | L1_HU_ICF_Pre-Screening_Hungarian | 6.0 |
| Subject information and informed consent form (for publication) | L1_HU_ICF_Pregnant Participant_Hungarian | 5.0 |
| Subject information and informed consent form (for publication) | L1_HU_ICF_Pregnant Partner_Hungarian | 4.0 |
| Subject information and informed consent form (for publication) | L1_HU_SIS_Addendum to Main_Hungarian | 1.0 |
| Subject information and informed consent form (for publication) | L1_HU_SIS_Continuation Discordance_Hungarian | 4.0 |
| Subject information and informed consent form (for publication) | L1_HU_SIS_Continuation Post disease progression_Hungarian | 6.0 |
| Subject information and informed consent form (for publication) | L1_HU_SIS_Crossover_Hungarian | 3.0 |
| Subject information and informed consent form (for publication) | L1_HU_SIS_Genetic_Hungarian | 3.0 |
| Subject information and informed consent form (for publication) | L1_HU_SIS_Pre-Screening_Hungarian_redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_HU_SIS_Pregnant Participant_Hungarian_redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_HU_SIS_Pregnant Partner_Hungarian_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_HU_SIS-ICF_Main_Hungarian_redacted | 7.1 |
| Subject information and informed consent form (for publication) | L1_IE_SIS-ICF_Continuation Disease Progression | 5.1 |
| Subject information and informed consent form (for publication) | L1_IE_SIS-ICF_Crossover | 3.1 |
| Subject information and informed consent form (for publication) | L1_IE_SIS-ICF_Main Addendum | 1.0 |
| Subject information and informed consent form (for publication) | L1_IE_SIS-ICF_Main_redacted | 6.1 |
| Subject information and informed consent form (for publication) | L1_IE_SIS-ICF_Pre-Screening_redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_IE_SIS-ICF_Pregnancy Partner_redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_IE_SIS-ICF_Pregnancy partner_redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_IE_SIS-ICF_Pregnancy_initial_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_IE_SIS-ICF_Pregnancy_redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_IT_EC Approval1_Italian_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_IT_EC Approval2_Italian_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_IT_SIS-ICF_Crossover_Italian | 4.0 |
| Subject information and informed consent form (for publication) | L1_IT_SIS-ICF_Main Addendum_Italian | 1.0 |
| Subject information and informed consent form (for publication) | L1_IT_SIS-ICF_Main_Italian_redacted | 11.0 |
| Subject information and informed consent form (for publication) | L1_IT_SIS-ICF_Partner pregnancy_Italian_redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_IT_SIS-ICF_Post disease progression_Italian | 9.0 |
| Subject information and informed consent form (for publication) | L1_IT_SIS-ICF_Pregnancy_Italian_redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_IT_SIS-ICF_Prescreening_Italian_redacted | 10.0 |
| Subject information and informed consent form (for publication) | L1_NL_SIS-ICF_Continuation Post-disease_Dutch_redacted | 9.1 |
| Subject information and informed consent form (for publication) | L1_NL_SIS-ICF_Crossover_Dutch_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_NL_SIS-ICF_Main_Dutch_redacted | 11.1 |
| Subject information and informed consent form (for publication) | L1_NL_SIS-ICF_Pre-Screening_Dutch_redacted | 9.0 |
| Subject information and informed consent form (for publication) | L1_NL_SIS-ICF_Pregnancy FU_Dutch_redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_NL_SIS-ICF_Pregnant Partner_Dutch_redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_PL_SIS-ICF_Continuation - Post Disease Progression_Polish | 8.0 |
| Subject information and informed consent form (for publication) | L1_PL_SIS-ICF_Crossover_Polish | 4.0 |
| Subject information and informed consent form (for publication) | L1_PL_SIS-ICF_Main_Addendum_Polish | 1.0 |
| Subject information and informed consent form (for publication) | L1_PL_SIS-ICF_Main_Polish_redacted | 10.0 |
| Subject information and informed consent form (for publication) | L1_PL_SIS-ICF_Pregnancy_Polish | 6.0 |
| Subject information and informed consent form (for publication) | L1_PL_SIS-ICF_Pregnant Partner_Polish_redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_PL_SIS-ICF_Prescreening_Polish_redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_PT_SIS-ICF_Continuation-Post Disease Progression_Portuguese | 9.0 |
| Subject information and informed consent form (for publication) | L1_PT_SIS-ICF_Crossover_Portuguese | 4.0 |
| Subject information and informed consent form (for publication) | L1_PT_SIS-ICF_Main Addendum ICF_Portuguese | 1.0 |
| Subject information and informed consent form (for publication) | L1_PT_SIS-ICF_Main_Portuguese_redacted | 11.0 |
| Subject information and informed consent form (for publication) | L1_PT_SIS-ICF_Participant Pregnancy_Portuguese | 8.0 |
| Subject information and informed consent form (for publication) | L1_PT_SIS-ICF_Pregnant Partner_Portuguese_redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_PT_SIS-ICF_Prescreening_Portuguese_redacted | 9.0 |
| Subject information and informed consent form (for publication) | L1-EL_SIS-ICF_Pregnant Partner_Greek_redacted | 7.1 |
| Subject information and informed consent form (for publication) | L2_BE_Other subject material_Scout ICF_Dutch_redacted | 1.3 |
| Subject information and informed consent form (for publication) | L2_BE_Other subject material_Scout ICF_French_redacted | 1.3 |
| Subject information and informed consent form (for publication) | L2_HU_Other subject material_Patient Emergency Card_Hungarian | 2.1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Taxotere | 52 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2023-507263-19-00_Dutch | 01 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2023-507263-19-00_French | 01 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2023-507263-19-00_German | 01 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol summary_2023-507263-19-00_Greek | 01 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2023-507263-19-00_Hungarian | 01 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2023-507263-19-00_Italian | 01 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2023-507263-19-00_Polish | 01 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2023-507263-19-00_Portuguese | 01 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2023-507263-19-00_Spanish | 01 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-05 | Spain | Acceptable 2024-07-11
|
2024-07-11 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-11-04 | Spain | Acceptable 2024-07-11
|
2024-11-04 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-02-20 | Spain | Acceptable 2025-05-30
|
2025-05-30 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-07-18 | Acceptable | 2025-08-25 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-09-18 | Spain | Acceptable | 2025-09-26 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-11-14 | Acceptable | 2025-12-22 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-12-12 | Acceptable | 2025-12-17 |