Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Authorised, recruiting
Participants planned
389
Countries
9
Sites
57
Non-small cell lung cancer
To evaluate the efficacy of two dosing regimens of adagrasib (600 mg BID without regard to food versus 400 mg BID with food) in patients with NSCLC with KRAS G12C mutation and who have received prior treatment with a platinum-based regimen and immune checkpoint inhibitor therapy.
Key facts
- Sponsor
- Mirati Therapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 29 Feb 2024 → ongoing
- Decision date (initial)
- 2024-02-02
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-503523-25-00
- WHO UTN
- U1111-1292-0568
- ClinicalTrials.gov
- NCT05853575
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Dose response, Safety, Therapy, Pharmacokinetic
To evaluate the efficacy of two dosing regimens of adagrasib (600 mg BID without regard to food versus 400 mg BID with food) in patients with NSCLC with KRAS G12C mutation and who have received prior treatment with a platinum-based regimen and immune checkpoint inhibitor therapy.
Secondary objectives 4
- To evaluate the safety and tolerability in the study population.
- To evaluate secondary efficacy endpoints in the study population.
- To evaluate the PK of the two dosing regiments of adagrasib administered in the study population.
- To evaluate patient-reported symptoms toxicity during adagrasib administration.
Conditions and MedDRA coding
Non-small cell lung cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10059515 | Non-small cell lung cancer metastatic | 100000004864 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Are at least 18 years old (or old enough to legally make their own treatment decisions, according to local laws).
- Have advanced NSCLC or metastatic NSCLC (NSCLC that started in the lungs and then spread to other parts of the body) with the KRAS G12C mutation.
- Have had previous treatment with 1) chemotherapy that included a drug called cisplatin or a drug called carboplatin and 2) a type of drug called an immune checkpoint inhibitor.
- Have recovered from their prior treatment and blood tests are within a safe range.
Exclusion criteria 3
- Have had previous treatment with a drug that targets KRAS G12C.
- Have cancer that can potentially be removed with surgery.
- Have certain medical conditions or need to take certain medications that, in the opinion of a trial doctor, could make it unsafe for them to participate or difficult to complete the trial assessments, or are pregnant.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Objective Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) per BICR.
Secondary endpoints 4
- Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of AEs, laboratory abnormalities, and number of patients modifying or discontinuing study treatment due to an AE.
- Secondary efficacy endpoints: Overall Survival (OS), Progression-Free Survival (PFS) per BICR, Duration of Response (DOR) per BICR.
- Summary statistics of adagrasib plasma concentrations.
- Patient-Reported Outcome (PRO) scores using PRO-CTCAE and 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 USE
- Max daily dose
- 1200 mg milligram(s)
- Max total dose
- 9999999 mg milligram(s)
- Max treatment duration
- 9999999 Day(s)
- Authorisation status
- Not Authorised
- ATC code
- NOTASSIGN — -
- MA holder
- MIRATI THERAPEUTICS INC
- Paediatric formulation
- No
- Orphan designation
- 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
- GSM-CT
Public contact point
- Organisation
- Mirati Therapeutics Inc.
- Contact name
- GSM-CT
Third parties 12
| Organisation | City, country | Duties |
|---|---|---|
| Resolution Bioscience Inc. ORG-100048922
|
Kirkland, United States | Laboratory analysis |
| Labcorp Early Development Laboratories Inc. ORG-100012865
|
Madison, United States | Laboratory analysis |
| Labconnect LLC ORG-100042800
|
Johnson City, United States | Other |
| PPD Development LP ORG-100011560
|
Wilmington, United States | Code 8 |
| Azenta Germany GmbH ORG-100039257
|
Griesheim, Germany | Other |
| Parexel International (IRL) Limited ORG-100022780
|
Dublin 2, Ireland | On site monitoring, Code 10, Code 12, Code 2, Code 5, Data management, Code 8 |
| Bioclinica Inc. ORG-100033079
|
Princeton, United States | Other |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Code 8 |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | Other, Interactive response technologies (IRT), E-data capture |
| Excelya Greece CRO Single Member S.A. ORG-100009224
|
Vrilissia, Greece | On site monitoring, Code 12, Code 2, Code 5, Code 8 |
| JMAC Partners, LLC ORL-000002617
|
Missouri, United States | Other |
| Resolution Bioscience Inc. ORG-100048922
|
Kirkland, United States | Other |
Locations
9 EU/EEA countries · 57 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Croatia | Ended | 10 | 3 |
| France | Ongoing, recruitment ended | 100 | 13 |
| Greece | Ongoing, recruitment ended | 45 | 6 |
| Hungary | Ended | 8 | 2 |
| Italy | Ongoing, recruitment ended | 18 | 6 |
| Netherlands | Ongoing, recruitment ended | 18 | 2 |
| Poland | Ended | 9 | 4 |
| Romania | Ongoing, recruitment ended | 24 | 8 |
| Spain | Ongoing, recruitment ended | 35 | 13 |
| Rest of world
Serbia, Thailand, Brazil, South Africa, Mexico, Taiwan, Israel, Peru, Turkey, United States, Korea, Republic of
|
— | 122 | — |
Investigational sites
University Hospital Center Zagreb
Pulmonary, Jordanovac 104, 10 000, Zagreb
Klinicki bolnicki centar Sestre milosrdnice
Oncology, Vinogradska Cesta 29, Zagreb, Grad Zagreb
Specijalna Bolnica Medico
Oncology, Agaticeva 8, 51000, Rijeka
Groupe Hospitalier Bretagne Sud
Service d'Oncologie Medicale, 5 Avenue Etienne Francois De Choiseul, 56100, Lorient
GIE Groupe hospitalier Paris Saint-Joseph/Vinci
Pneumo-oncology and Allergology department, 185 Rue Raymond Losserand, 75014, Paris
Centre Hospitalier Universitaire Grenoble Alpes
Unité d'Oncologie thoracique, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9
Institut De Cancerologie De L Ouest
Service d'Oncologie Medicale, Bd Du Professeur Jacques Monod, 44800, St Herblain
Assistance Publique Hopitaux De Marseille
Service d'Oncologie Multidisciplinaire et Innovations Thérapeutiques, 265 Chemin Des Bourrely, 13015, Marseille
Direction Centrale Du Service De Sante Des Armees
Service d'Oncologie, 69 Avenue De Paris, 94160, Saint-Mande
Centre Hospitalier Universitaire De Poitiers
Service d’oncologie Médicale Oncologie Medicale - Cancerolo, 2 Rue De La Miletrie, 86000, Poitiers
Centre Hospitalier Universitaire De Bordeaux
Maladies respiratoires, Avenue De Magellan, 33600, Pessac
Centre Hospitalier Universitaire De Nantes
Service dOncologie medicale – Unite dOncologie thoracique, Boulevard Du Professeur Jacques Monod, 44800, Saint Herblain
Centre Hospitalier Intercommunal De Cornouaille
Oncologie thoracique, 14 Avenue Yves Thepot, Bp 31757, Quimper Cedex
Les Hopitaux Nord-Ouest
Oncologie Medicale - Cancerolo, Plateau D Ouilly, Cs 80436 Gleize, Villefranche Sur Saone Cedex
Centre Hospitalier Universitaire D'Angers
Département de PNEUMOLOGIE, 4 Rue Larrey, 49100, Angers
Centre Hospitalier Universitaire De Nice
Pneumologie, Oncologie thoracique, Soins intensifs respiratoires, 30 Voie Romaine, 06000, Nice
Theageneio Cancer Hospital
Pulmonary Oncology Department, Simeonidi Alex 2, 546 39, Thessaloniki
University General Hospital Attikon
Oncology Unit, Rimini Street 1, 124 62, Athens
St. Luke's Hospital S.A.
Oncology Department, Harilaou Trikoupi Str. 3, 552 36, Thessaloniki
General University Hospital Of Patras
Department of Medicine, Division of Oncology, Rio, 265 04, Patras
General Hospital Of Thessaloniki Papageorgiou
2nd Department of Medical Oncology, Ring Road Of Thessaloniki, Ministry Of Pavlos Melas, Efkarpia
Alexandra Hospital
Oncology Department of Therapeutic Clinic, Vassilissas Sofias Avenue 80, 115 28, Athens
Koranyi National Institute For Pulmonology
Tüdőbelosztály és Bronchológia, Koranyi Frigyes Ut 1, 1121, Budapest XII
University Of Debrecen
Tüdőgyógyászati Klinika, Nagyerdei Korut 98, 4032, Debrecen
Istituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia IRCCS
Oncologia, Strada Provinciale 142 Orba Km 3,95, 10060, Candiolo
I.F.O. Istituti Fisioterapici Ospitalieri
Unità di Oncologia Medica 2, Via Elio Chianesi N 53, 00144, Rome
Istituto Europeo Di Oncologia S.r.l.
Divisione di Oncologia Toracica, Via Giuseppe Ripamonti 435, 20141, Milan
Azienda Sanitaria Territoriale Pesaro Urbino (AST PU)
UOC Oncologia, stabilimento di Pesaro (Ospedale San Salvatore), Via Cesare Lombroso 1, Pesaro
University Hospital Of Perugia
S. C. Oncologia Medica, Via Gerardo Dottori 1, 06132, Perugia
Azienda Ospedaliero-Universitaria Maggiore Della Carita
SCDU OncologiaDipartimento Specialistico ed Oncologico, Corso Giuseppe Mazzini 18, 28100, Novara
Netherlands Cancer Institute
800: Pulmonology, Plesmanlaan 121, 1066 CX, Amsterdam
St. Antonius Ziekenhuis
801: Pulmonology - Oncology, Koekoekslaan 1, 3435 CM, Nieuwegein
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
652: Oddz. Chemioterapii Nowotworow z Pododdzialem Chemioterapii Jednego Dnia, Ul. Pabianicka 62, 93-513, Lodz
Ms Pneumed Janusz Milanowski Katarzyna Szmygin-Milanowska Spolka Jawna
653: Oncology, Polnocna 18 Lok U1, 20-064, Lublin
Szpitale Pomorskie Sp. z o.o.
651:Szpital Morski im.PCKOddzial Onkologii i Radioterapii-Onkologia Kliniczna Leczenie Jednego dnia, Ul. Powstania Styczniowego 1, 81-519, Gdynia
Pratia S.A.
650: Oncology, Ul. Pana Tadeusza 2, 30-727, Cracow
Sigmedical Services S.R.L.
728: Oncology, Bis The Building Corp A, Strada Zamca Nr 21 Et 3, Suceava
Oncocenter Oncologie Clinica S.R.L.
730: Oncology, Strada Garii 1a, 300166, Timisoara
Centrul De Oncologie-Euroclinic S.R.L.
733: Oncology, Strada Conta Vasile 2, 700106, Iasi
Medisprof S.R.L.
732: Oncology, Bulevardul Muncii 96, 400641, Cluj-Napoca
Ovidius Clinical Hospital S.R.L.
731: Oncology, Dn 2a Km 202 880, 905900, Ovidiu
Oncolab S.R.L.
729: Medical oncology, Strada Bujorului 7, 200385, Craiova
Spitalul Clinic Judetean De Urgenta Sibiu
725: Medical Oncology, Bulevardul Coposu Corneliu 2-4, 550245, Sibiu
Centrul De Oncologie SF Nectarie S.R.L.
734: Oncology, Strada Caracal Nr 109, 200542, Craiova
Hospital Universitari Dexeus Grupo Quironsalud
Oncología Médica, Calle De Sabino Arana 5-19, 08028, Barcelona
Complexo Hospitalario Universitario De Santiago
Oncología Médica, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Clinico San Carlos
Oncología Médica, Calle Del Profesor Martín Lagos S/n, 28040, Madrid
Hospital Universitari Vall D Hebron
Oncología Médica, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital De La Santa Creu I Sant Pau
Oncología Médica, Calle De San Antonio Maria Claret 167, 08025, Barcelona
Hospital General Universitario Gregorio Maranon
Oncología Médica, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Clinic De Barcelona
Oncología Médica, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario Virgen De La Macarena
Oncología Médica, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital Universitario Regional De Malaga
Oncología, Avenida De Carlos De Haya Sn, 29010, Malaga
Hospital Universitario Central De Asturias
Oncología Médica, Avenida De Roma S/n, 33011, Oviedo
Hospital Clinico Universitario De Valencia
Oncologia Médica y Hematologia, Avenida Blasco Ibanez 17, 46010, Valencia
University Hospital Son Espases
Oncología, Carretera Valldemossa 79, 07120, Palma
MD Anderson Cancer Center
Oncología, Calle De Arturo Soria Nº 270, 28033, Madrid
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 |
|---|---|---|---|---|---|
| Croatia | 2024-06-06 | 2026-03-26 | 2024-10-01 | 2025-07-21 | |
| France | 2024-02-29 | 2024-03-21 | 2025-07-21 | ||
| Greece | 2024-10-03 | 2024-10-03 | 2025-07-21 | ||
| Italy | 2024-09-04 | 2024-09-20 | 2025-07-21 | ||
| Netherlands | 2025-01-07 | 2025-02-19 | 2025-07-21 | ||
| Poland | 2024-08-08 | 2026-03-05 | 2025-07-20 | 2025-07-21 | |
| Romania | 2024-07-18 | 2025-01-13 | 2025-07-21 | ||
| Spain | 2024-04-11 | 2024-05-28 | 2025-07-21 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Corrective measures 1 · Art. 77 CTR
Corrective measure CM-FR-0001
- Member state
- France
- Publication date
- 2024-03-06
- Type
- 3
- Reason
- 5
- Immediate action required
- Yes
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 103 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol Admin letter_ 2023-503523-25 redacted | 3 |
| Protocol (for publication) | D1_Protocol Main Greek 849-021 Public | 3.0 |
| Protocol (for publication) | D1_Protocol_ 2023-503523-25 redacted | 3 |
| Protocol (for publication) | ESP Subject Diary 400 mg BID Spanish 849-021 Public | 1.0 |
| Protocol (for publication) | ESP Subject Diary 600 mg BID Spanish 849-021 Public | 1.0 |
| Protocol (for publication) | ESP Subject Questionnaire EQ-5D-5L Spanish 849-021 Public | 1.0 |
| Protocol (for publication) | ESP Subject Questionnaire NCI-PRO-CTCAE Spanish 849-021 Public | 1.0 |
| Protocol (for publication) | FRA Subject Diary 400 mg BID French 849-021 Public | 1.0 |
| Protocol (for publication) | FRA Subject Diary 600 mg BID French 849-021 Public | 1.0 |
| Protocol (for publication) | FRA Subject Questionnaire EQ-5D-5L French 849-021 Public | 1.0 |
| Protocol (for publication) | FRA Subject Questionnaire NCI-PRO-CTCAE French 849-021 Public | 1.0 |
| Protocol (for publication) | GRC Subject Diary 400 mg BID Greek 849-021 Public | 1.0 |
| Protocol (for publication) | GRC Subject Diary 600 mg BID Greek 849-021 Public | 1.0 |
| Protocol (for publication) | GRC Subject Questionnaire EQ-5D-5L Greek 849-021 Public | 1.0 |
| Protocol (for publication) | GRC Subject Questionnaire NCI-PRO-CTCAE Greek 849-021 Public | 1.0 |
| Protocol (for publication) | HRV Subject Diary 400 mg BID Croatian 849-021 Public | 1.0 |
| Protocol (for publication) | HRV Subject Diary 600 mg BID Croatian 849-021 Public | 1.0 |
| Protocol (for publication) | HRV Subject Questionnaire EQ-5D-5L Croatian 849-021 Public | 1.0 |
| Protocol (for publication) | HRV Subject Questionnaire NCI-PRO-CTCAE Croatian 849-021 Public | 1.0 |
| Protocol (for publication) | HUN Subject Diary 400 mg BID Hungarian 849-021 Public | 1.0 |
| Protocol (for publication) | HUN Subject Diary 600 mg BID Hungarian 849-021 Public | 1.0 |
| Protocol (for publication) | HUN Subject Questionnaire EQ-5D-5L Hungarian 849-021 Public | 1.1 |
| Protocol (for publication) | HUN Subject Questionnaire NCI-PRO-CTCAE Hungarian 849-021 Public | 1.0 |
| Protocol (for publication) | NLD Subject Diary 400 mg BID Dutch 849-021 Public | 1.0 |
| Protocol (for publication) | NLD Subject Diary 600 mg BID Dutch 849-021 Public | 1.0 |
| Protocol (for publication) | NLD Subject Questionnaire EQ-5D-5L English Transparency Placeholder 849-021 | NA |
| Protocol (for publication) | NLD Subject Questionnaire NCI-PRO-CTCAE Dutch 849-021 Public | 1.0 |
| Protocol (for publication) | POL Subject Diary 400 mg BID AM Bilingual 849-021 Public | 1.0 |
| Protocol (for publication) | POL Subject Diary 600 mg BID AM Bilingual 849-021 Public | 1.0 |
| Protocol (for publication) | POL Subject Questionnaire NCI-PRO-CTCAE AM Polish 849-021 Public | 1.0 |
| Protocol (for publication) | Protocol clarification letter English 849-021 Public | N/A |
| Protocol (for publication) | ROU Subject Diary 400 mg BID Bilingual 849-021 Public | 1 |
| Protocol (for publication) | ROU Subject Diary 600 mg BID Bilingual 849-021 Public | 1 |
| Protocol (for publication) | ROU Subject Questionnaire EQ-5D-5L English Transparency Placeholder 849-021 | N/A |
| Protocol (for publication) | ROU Subject Questionnaire NCI-PRO-CTCAE Romanian 849-021 Public | 1 |
| Protocol (for publication) | Subject Diary 400 mg BID English 849-021 Public | 1.0 |
| Protocol (for publication) | Subject Diary 600 mg BID English 849-021 Public | 1.0 |
| Recruitment arrangements (for publication) | ESP Recruitment Procedure Description English 849-021 Public | 1.0 |
| Recruitment arrangements (for publication) | FRA Recruitment Procedure Description French 849-021 | 1.0 |
| Recruitment arrangements (for publication) | GRC Recruitment Procedure Description English 849-021 Public | 1.0 |
| Recruitment arrangements (for publication) | HRV Country ICF Procedure English 849-021 Public | 1.0 |
| Recruitment arrangements (for publication) | HRV Recruitment Procedure Description English 849-021 Public | 1.0 |
| Recruitment arrangements (for publication) | ITA Country Recruitment Procedure English 849-021 Public | 2.0 |
| Recruitment arrangements (for publication) | NLD Recruitment Procedure Description English 849-021 Public | 1.0 |
| Recruitment arrangements (for publication) | POL Recruitment Procedure Description AM bilingual 849-021 Public | 1.0 |
| Recruitment arrangements (for publication) | ROU Country Recruitment Procedure English 849-021 | 1.0 |
| Subject information and informed consent form (for publication) | GRC Country ICF Procedure English 849-021 Public | 1.0 |
| Subject information and informed consent form (for publication) | ITA Country ICF Genetic Research Italian 849-021 Public | 1.0 |
| Subject information and informed consent form (for publication) | ITA Country ICF Procedure English 849-021 Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_ESP Country ICF Genetic Research Spanish 849-021 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_ESP Country ICF Main Spanish 849-021 Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_ESP Country ICF Pregnancy Partner Spanish 849-021 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_ESP Country ICF Pregnant Participant Spanish 849-021 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_ESP Country ICF Screening Spanish 849-021 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_FRA Country ICF Main French 849-021 Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_FRA Country ICF Pregnant Participant French 849-021 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_FRA Country ICF Pregnant Partner French 849-021 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_FRA Country ICF Screening French 849-021 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_GRC Country ICF Adult Pregnant Participant English 849-021 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_GRC Country ICF Adult Pregnant Participant Greek 849-021 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_GRC Country ICF Adult Pregnant Partner English 849-021 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_GRC Country ICF Adult Pregnant Partner Greek 849-021 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_GRC Country ICF Main Adult English 849-021 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_GRC Country ICF Main Adult Greek 849-021 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_GRC Country ICF Screening Adult English 849-021 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_GRC Country ICF Screening Adult Greek 849-021 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_HRV Country ICF Main Croatian 849-021 Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_HRV Country ICF Pregnant Participant Croatian 849-021 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_HRV Country ICF Pregnant Partner Croatian 849-021 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_HRV Country ICF Research Croatian 849-021 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_HRV Country ICF Screening Croatian 849-021 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_ITA Country ICF Data Protection Italian 849-021 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_ITA Country ICF Genetic Research Italian 849-021 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_ITA Country ICF Main Italian 849-021 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_ITA Country ICF Pregnancy FU Partner Italian 849-021 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_ITA Country ICF Pregnant Participant FU Italian 849-021 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_ITA Country ICF Screening Italian 849-021 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_NLD Country ICF Main Dutch 849-021 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_NLD Country ICF Screening Dutch 849-021 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_NLD Country Pregnant Partner ICF Dutch 849-021 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_NLD Country Pregnant subject ICF Dutch 849-021 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_POL Country ICF Main Polish 849-021 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_POL Country ICF Other Pregnant Partner Polish 849-021 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_POL Country ICF Other Pregnant Patient Polish 849-021 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_POL Country ICF Screening Polish 849-021 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_ROU Country ICF Main Romanian 849-021 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_ROU Country ICF Pregnant Participant Romanian 849-021 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_ROU Country ICF Pregnant Partner Romanian 849-021 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_ROU Country ICF Screening Adult Romanian 849-021 Public | 3.0 |
| Subject information and informed consent form (for publication) | L2_ FRA_Travel Confirmation email to participant_French 849-021 Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_FRA_Brochure for participant_ French 849-021 Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_FRA_Patient expenses reimbursement request form_French 849-021 Public | 6.0 |
| Subject information and informed consent form (for publication) | ROU Country ICF Procedure English 849-021 Public | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ 2023-503523-25 | 3 |
| Synopsis of the protocol (for publication) | Lay Protocol Synopsis Main AM Polish 849-021 Public | 3.0 |
| Synopsis of the protocol (for publication) | Lay Protocol Synopsis Main Croatian 849-021 Public | 3.0 |
| Synopsis of the protocol (for publication) | Lay Protocol Synopsis Main Dutch 849-021 Public | 3.0 |
| Synopsis of the protocol (for publication) | Lay Protocol Synopsis Main French 849-021 Public | 3.0 |
| Synopsis of the protocol (for publication) | Lay Protocol Synopsis Main Greek 849-021 Public | 2.0 |
| Synopsis of the protocol (for publication) | Lay Protocol Synopsis Main Hungarian 849-021 Public | 2.0 |
| Synopsis of the protocol (for publication) | Lay Protocol Synopsis Main Italian 849-021 Public | 3.0 |
| Synopsis of the protocol (for publication) | Lay Protocol Synopsis Main Romanian 849-021 Public | 3.0 |
| Synopsis of the protocol (for publication) | Lay Protocol Synopsis Main Spanish 849-021 Public | 3.0 |
Application history
14 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-05-25 | France | Acceptable 2023-09-15
|
2023-12-15 |
| 2 | SUBSEQUENT ADDITION OF MSC | APP-2 | 2024-02-09 | 2024-05-08 | ||
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-03-14 | France | Acceptable | 2024-04-05 |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-03-15 | Acceptable | 2024-04-24 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-03-15 | Acceptable | 2024-04-26 | |
| 6 | SUBSEQUENT ADDITION OF MSC | APP-6 | 2024-03-18 | Acceptable 2023-09-15
|
2024-06-14 | |
| 7 | SUBSEQUENT ADDITION OF MSC | APP-7 | 2024-03-21 | Acceptable 2023-09-15
|
2024-06-17 | |
| 8 | SUBSEQUENT ADDITION OF MSC | APP-8 | 2024-03-22 | Acceptable 2023-09-15
|
2024-06-17 | |
| 9 | SUBSEQUENT ADDITION OF MSC | APP-9 | 2024-03-26 | Acceptable 2023-09-15
|
2024-06-21 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-08-13 | France | Acceptable 2024-10-09
|
2024-10-09 |
| 11 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-11-04 | France | Acceptable 2024-10-09
|
2024-11-04 |
| 12 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-02-14 | France | Acceptable 2025-05-21
|
2025-05-21 |
| 13 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-07-03 | France | Acceptable 2025-05-21
|
2025-07-03 |
| 14 | SUBSTANTIAL MODIFICATION | SM-8 | 2026-03-03 | France | Acceptable | 2026-03-20 |