Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
188
Countries
12
Sites
51
BRCA Mutated Ovarian Cancer Patients, Epithelian ovarian cancer, Metastatic Breast Cancer, Platinum Sensitive Relapsed Ovarian Cancer, Patients with gBRCA mutated metastatic pancreatic cancer, prostate cancer, endometrium cancer
To provide continuous study treatment to patients who continue to benefit at the end of a clinical trial, while monitoring safety and tolerability
Key facts
- Sponsor
- AstraZeneca AB
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 28 Jun 2021 → ongoing
- Decision date (initial)
- 2024-08-14
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- AstraZeneca AB
External identifiers
- EU CT number
- 2024-512982-15-00
- EudraCT number
- 2019-003777-26
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
To provide continuous study treatment to patients who continue to benefit at the end of a clinical trial, while monitoring safety and tolerability
Conditions and MedDRA coding
BRCA Mutated Ovarian Cancer Patients, Epithelian ovarian cancer, Metastatic Breast Cancer, Platinum Sensitive Relapsed Ovarian Cancer, Patients with gBRCA mutated metastatic pancreatic cancer, prostate cancer, endometrium cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10016180 | Fallopian tube cancer | 100000004864 |
| 20.0 | PT | 10006187 | Breast cancer | 100000004864 |
| 20.0 | PT | 10060862 | Prostate cancer | 100000004864 |
| 27.0 | LLT | 10033605 | Pancreatic cancer metastatic | 10029104 |
| 20.0 | PT | 10033128 | Ovarian cancer | 100000004864 |
| 21.0 | PT | 10014733 | Endometrial cancer | 100000004864 |
Study design 2 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Treatment period Olaparib tablets (300 mg twice daily, continuously, or per dose reduction scheme) should be taken at the same time each day, approximately 12 hours apart, with 1 glass of water. The tablets should be swallowed whole and not chewed, crushed, dissolved, or divided. Olaparib can be taken with or without food. There is no maximum duration for taking olaparib. Patients should continue to receive olaparib until they meet any of the study discontinuation criterion.
|
2 | None | Treatment arm: Olaparib tablets (300 mg twice daily, continuously, or per dose reduction scheme) should be taken at the same time each day, approximately 12 hours apart, with 1 glass of water. | |
| 2 | Follow-up period A safety follow-up visit will be conducted approximately 30 days after last dose of study drug
|
2 | None |
Regulatory references
- Plan to share IPD
- Yes
- IPD plan description
- Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-507337-22-00 | Roll Over Study for Patients Who Have Completed a Previous Oncology Study with Durvalumab and Are Judged by the Investigator to Clinically Benefit From Continued Treatment | Astrazeneca AB |
| 2022-501528-58-00 | ROSY-T: Roll Over StudY for Patients Who Have Completed a Previous Oncology Study with Osimertinib (TAGRISSO) and are Judged by the Investigator to Clinically Benefit From Continued Treatment | Astrazeneca AB |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- 1 Provision of signed and dated, written ICF.
- 2 Patient is currently deriving clinical benefit, as judged by the Investigator, from continued treatment in an AZ parent study using an AstraZeneca (AZ) compound that has met its endpoints or has otherwise stopped.
- 3 Patient participating in a prior oncology study with an AZ compound in which they received olaparib and are continuing to receive clinical benefit from treatment; the prior study can be an open-label or blinded study, with unblinding at study close.
Exclusion criteria 5
- 1 Ongoing, unresolved, Grade 3 or above toxicity requiring interruption of treatment at the time of the termination of the parent study.
- 2 Currently receiving treatment with any prohibited medication(s).
- 3 Concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
- 4 Permanent discontinuation from the parent study due to toxicity or disease progression (increase in the severity of the disease under study and/or increases in the symptoms of a patient's condition attributable to the disease, as assessed and documented by the Investigator. Physician-defined progression can be radiological [eg, RECIST] progression or clinical progression).
- 5 Local access to commercially-available drug at no cost to the patient, as permitted by local/country regulation.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- SAEs and AESIs reported until 30 days after the last dose of study drug.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Lynparza 150 mg film-coated tablets
PRD6152224 · Product
- Active substance
- Olaparib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 123 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XX46 — -
- Marketing authorisation
- EU/1/14/959/004
- MA holder
- ASTRAZENECA AB
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Lynparza Tablet is identical to the IMP except that it has a commercial deboss/marking. The IMP is unmarked and provided in an HDPE bottle rather than the commercial blister pack to facilitate blinding in placebo-controlled studies
Lynparza 100 mg film-coated tablets
PRD6163466 · Product
- Active substance
- Olaparib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 123 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XX46 — -
- Marketing authorisation
- EU/1/14/959/003
- MA holder
- ASTRAZENECA AB
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Lynparza Tablet is identical to the IMP except that it has a commercial deboss/marking. The IMP is unmarked and provided in an HDPE bottle rather than the commercial blister pack to facilitate blinding in placebo-controlled studies
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
AstraZeneca AB
- Sponsor organisation
- AstraZeneca AB
- Address
- -
- City
- Sodertalje
- Postcode
- 151 85
- Country
- Sweden
Scientific contact point
- Organisation
- AstraZeneca AB
- Contact name
- Clinical Study Information Center
Public contact point
- Organisation
- AstraZeneca AB
- Contact name
- Clinical Study Information Center
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Parexel International (IRL) Limited ORG-100022780
|
Dublin 2, Ireland | On site monitoring, Code 10, Code 11, Code 12, Other, Data management |
Locations
12 EU/EEA countries · 51 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 2 | 2 |
| Bulgaria | Ongoing, recruiting | 7 | 2 |
| Czechia | Ongoing, recruiting | 14 | 5 |
| France | Ongoing, recruiting | 4 | 4 |
| Germany | Ongoing, recruiting | 1 | 1 |
| Hungary | Ongoing, recruiting | 2 | 2 |
| Italy | Ongoing, recruiting | 19 | 14 |
| Poland | Ongoing, recruiting | 13 | 6 |
| Portugal | Ongoing, recruiting | 2 | 2 |
| Slovenia | Ongoing, recruiting | 2 | 1 |
| Spain | Ongoing, recruiting | 25 | 11 |
| Sweden | Ongoing, recruiting | 3 | 1 |
| Rest of world
United Kingdom, Korea, Republic of, Taiwan, Russian Federation, United States, Brazil, Israel, Canada, China, Turkey
|
— | 94 | — |
Investigational sites
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
0502: Oncology, Place Louise Godin 15, 5000, Namur
UZ Leuven
0501: Gynaecologische Oncologie, Herestraat 49, 3000, Leuven
Medical Centre Nadezhda Clinical EOOD
0902, Blaga Vest Str 3, 1303, Sofia
Complex Oncological Center Plovdiv EOOD
0907, Bulevard Aleksandir Stamboliyski 2a, 4004, Plovdiv
Fakultni Nemocnice Ostrava
1902: Onkologicka klinika, 17. Listopadu 1790/5, Poruba, Ostrava
University Hospital Olomouc
1906: Onkologicka klinika, Zdravotniku 248/7, 779 00, Olomouc
Masarykuv Onkologicky Ustav
1905: Odd. gynekologicke onkologie, Zluty Kopec 543/7, Stare Brno, Brno-Stred
Vseobecna Fakultni Nemocnice V Praze
1901: Gynekolog-porodnicka klinika, Apolinarska 441/18 Nove Mesto, 128 00, Prague
Fakultni Nemocnice Brno
1907: Klinika gynekologie, porodnictvi a neonatologie FN Brno, Jihlavska 340/20, Bohunice, Brno
Hopital Prive Des Cotes D'armor
2307: Service Oncologie, 10 Rue Francois Jacob, 22190, Plerin
Centre Oscar Lambret
2314: Centre Oscar Lambret, 3 Rue Frederic Combemale, 59000, Lille
Centre Leon Berard
2310: Département d'Oncologie Médicale, 28 Rue Laennec, 69008, Lyon
Hopital Paul Brousse
2313: Oncology, 12 Avenue Paul Vaillant Couturier, 94804, Villejuif Cedex
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
2601: Frauenheilkunde, Geburtshilfe, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Szent Margit Korhaz
3302:Onkológia, Becsi Ut 132, 1032, Budapest III
Orszagos Onkologiai Intezet
3301:Nőgyógyászati Onkológia, Rath Gyorgy Utca 7-9, Kerulet, Budapest XII
IRCCS Istituto Nazionale Tumori Fondazione Pascale
4101:Dipartimento Uro-Ginecologico, Via Mariano Semmola 52, 80131, Naples
Istituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia IRCCS
4104:Day Hospital Oncologico, Strada Provinciale 142 Orba Km 3,95, 10060, Candiolo
Azienda Ospedaliera Universitaria Integrata Verona
4117:Oncologia, Piazzale Ludovico Antonio Scuro 10, 37134, Verona
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
4106:Divisione di Ostetricia e Ginecologia, Piazzale Spedali Civili 1, 25123, Brescia
Azienda Ospedaliera Ordine Mauriziano Di Torino
4114:Unità di Oncologia Ginecologica, Via Ferdinando Magellano 1, 10128, Turin
Ospedale Vito Fazzi Lecce
4111:U.O.C. di Oncologia Medica, Piazza Filippo Muratore 1, 73100, Lecce
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
4108:SSD Oncol.Med. Addarii-Zamagni, Via Pietro Albertoni 15, 40138, Bologna
Azienda Ospedaliera Per L'Emergenza Cannizzaro
4110:Ginecologia oncologica, Via Messina 829, 95126, Catania
Azienda Ospedaliero Universitaria Delle Marche
4112:Clinica Oncologica, Via Conca 71, 60126, Ancona
Universita Cattolica Del Sacro Cuore
4105:Ginecologia oncologica, Largo Agostino Gemelli 8, 00168, Rome
Ospedale San Raffaele S.r.l.
4109:Unità Operativa di Ginecologia e Ostetricia I, Via Olgettina 60, 20132, Milan
Istituto Oncologico Veneto
4103:Oncologia Medica 2, Via Gattamelata 64, 35128, Padova
Istituto Europeo Di Oncologia S.r.l.
4113:Unità di Ginecologia OncologicUnità Operativa di Ginecologia e Ostetricia I, Via Giuseppe Ripamonti 435, 20141, Milan
Alessandro Manzoni Hospital
4118:Oncologia, Via Dell' Eremo 9, 23900, Lecco
Uniwersytecki Szpital Kliniczny W Poznaniu
5701: Klinika Ginekologii Onkologicznej, Ul. Augustyna Szamarzewskiego 84, 60-569, Poznan
Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku
5702: Oddzial Onkologii Ginekologicznej, Ul. Ogrodowa 12, 15-027, Bialystok
Wojewodzki Szpital Specjalistyczny W Olsztynie
5706: Oddzial Kliniczny Ginekologii Onkologicznej, Ul. Zolnierska 18, 10-561, Olsztyn
Wielkopolskie Centrum Onkologii Im. Marii Sklodowskiej-Curie
5708:Oddzial Radioterapii i Onkologii Ginekologicznej, Ul. Garbary 15, 61-866, Poznan
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli
5707: I Oddzial Ginekologii Onkologicznej z Pododdzialem Brachyterapii, Ul. Dra Kazimierza Jaczewskiego 7, 20-090, Lublin
Read-Gene S.A.
5705: NZOZ Innowacyjna Medycyna, Ul. Alabastrowa 8, Dobra (Szczecinska), Grzepnica
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
5801:Anesthesiology/Reanimation, Rua Dr. Antonio Bernardino De Almeida, 4200-072, Porto
Unidade Local De Saude De Santa Maria E.P.E.
5802: Oncologia, Avenida Professor Egas Moniz, 1649-035, Lisbon
Hospital Universitario Miguel Servet
7003: Oncología, Paseo De Isabel La Catolica 1-3, 50009, Zaragoza
Hospital Universitario Virgen De Las Nieves
7012: Oncología Medica, Avenida De Las Fuerzas Armadas 2, 18014, Granada
Clinica Universidad De Navarra
7011: Oncología Medica, Pio XII Etorbidea 36, 31008, Pamplona
Clinica Universidad De Navarra
7017: Oncología, Calle Marquesado De Santa Marta 1, 28027, Madrid
Hospital Universitario Y Politecnico La Fe
7001: Oncología, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Institut Catala D'oncologia
7007: Oncología Médica, Carretera Canyet S/n, 08916, Badalona
Complexo Hospitalario Universitario De Vigo
7009: Oncología Médica, Estrada Clara Campoamor N 341, 36312, Vigo
Hospital Universitario Donostia
7021: Oncologia, Pasealeku Doct. Begiristain 109, 20014, Donostia
Institut Catala D'oncologia
7006: Oncologia, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitari Vall D Hebron
7010: Oncología Médica, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Reina Sofia
7020: Oncología Medica, Avenida Menendez Pidal S/n, 14004, Cordoba
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 |
|---|---|---|---|---|---|
| Belgium | 2021-12-10 | 2021-12-10 | |||
| Bulgaria | 2021-06-28 | 2021-06-28 | |||
| Czechia | 2021-07-22 | 2021-07-22 | |||
| France | 2021-11-18 | 2021-11-18 | |||
| Germany | 2021-09-21 | 2021-09-21 | |||
| Hungary | 2021-07-07 | 2021-07-07 | |||
| Italy | 2021-07-23 | 2021-07-23 | |||
| Poland | 2021-08-18 | 2021-08-18 | |||
| Portugal | 2022-02-22 | 2022-02-22 | |||
| Slovenia | 2022-02-28 | 2022-02-28 | |||
| Spain | 2021-09-06 | 2021-09-06 | |||
| Sweden | 2021-11-18 | 2021-11-18 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 63 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol Main English D0817C00098 Public | 4.0 |
| Protocol (for publication) | D1_Protocol Substudy English D0817C00098 Public | 7.0 |
| Recruitment arrangements (for publication) | K1_BEL Recruitment Procedure Description English D0817C00098 Public | 1.0 |
| Recruitment arrangements (for publication) | K1_BGR Recruitment Procedure Description Bulgarian D0817C00098 Public | 2.0 |
| Recruitment arrangements (for publication) | K1_CZE Recruitment Procedure Description D0817C00098 Public | 1.0 |
| Recruitment arrangements (for publication) | K1_DEU Recruitment Procedure Description combined with ICF English D0817C00098 Public | 1.0 |
| Recruitment arrangements (for publication) | K1_ESP Recruitment Procedure Description English D0817C00098 Public | 1.0 |
| Recruitment arrangements (for publication) | K1_FRA Recruitment Procedure Description EN-FR D0817C00098 Public | 1.0 |
| Recruitment arrangements (for publication) | K1_FRA Trial Budget Description French D0817C00098 Public | 1.0 |
| Recruitment arrangements (for publication) | K1_POL Recruitment and Informed Consent Procedure Description PL-EN D0817C00098 Pubic | 1.0 |
| Recruitment arrangements (for publication) | K1_PRT Regulatory Filenote D0817C00098 | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements Transition placeholder D0817C00098 | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements Transition Placeholder D0817C00098 | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements Transition Placeholder D0817C00098 | NA |
| Recruitment arrangements (for publication) | K1_SVN Recruitment Procedure Description English D0817C00098 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_BEL Country ICF Main Dutch D0817C00098 Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_BEL Country ICF Main English D0817C00098 Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_BEL Country ICF Main French D0817C00098 Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_BGR Country ICF Main Bulgarian D0817C00098 Public | 7.0 |
| Subject information and informed consent form (for publication) | L1_BGR Country ICF Main English D0817C00098 Public | 7.0 |
| Subject information and informed consent form (for publication) | L1_BGR Country ICF Other Pregnant Partner ICF Bulgarian D0817C00098 Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_BGR Country ICF Other Pregnant Partner ICF English D0817C00098 Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_CZE Country ICF - Data Protection Adult GDPR Already Enrolled Pts Czech D0817C00098 Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_CZE Country ICF Main Adult Already enrolled patients Czech D0817C00098 Public | 7.0 |
| Subject information and informed consent form (for publication) | L1_CZE Country ICF Main Adult Czech D0817C00098 Public | 7.0 |
| Subject information and informed consent form (for publication) | L1_CZE Country ICF Other Adult Pregnant Participant Czech D0817C00098 Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_CZE Country ICF Other Adult Pregnant Partner Czech D0817C00098 Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_CZE Country ICF Privacy Adult Czech D0817C00098 Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_CZE Subject Participation Card Czech D0817C00098 Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_DEU ICF Main German D0817C00098 Public | 6.0 |
| Subject information and informed consent form (for publication) | L1_FRA Country ICF Main French D0817C00098 Public | 5.1 |
| Subject information and informed consent form (for publication) | L1_HUN Country ICF Main Adult Hungarian D0817C00098 Public | 7.0 |
| Subject information and informed consent form (for publication) | L1_HUN Country ICF Main Adult Patient Information Sheet Hungarian D0817C00098 Public | 6.0 |
| Subject information and informed consent form (for publication) | L1_HUN Country ICF Other Adult Pregnant Partn Patient Information Sheet Hungarian D0817C00098 Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_HUN Country ICF Other Adult Pregnant Partner Informed Consent Form Hungarian D0817C00098 Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_HUN Subject Participation Card Subject ID Card Hungarian D0817C00098 Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_HUN Subject Participation Card Subject ID Justification Letter English D0817C00098 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_ITA Country ICF Main Italian D0817C00098 Public | 7.0 |
| Subject information and informed consent form (for publication) | L1_ITA Country ICF Other Pregnant Form Italian D0817C00098 Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_ITA Country IRB-IEC Additional-Amendment Approval PP Italian D0817C00098 Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_ITA Country IRB-IEC Additional-Amendment Approval PT Material-Main ICF Italian D0817C00098 Public | 6.0 |
| Subject information and informed consent form (for publication) | L1_POL Country ICF Main Polish D0817C00098 Public | 7.0 |
| Subject information and informed consent form (for publication) | L1_POL Country ICF Other Pregnant Partner Polish D0817C00098 Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_PRT Country ICF Procedure English D0817C00098 | 1.0 |
| Subject information and informed consent form (for publication) | L1_Regulatory Filenote D0817C00098 Public | NA |
| Subject information and informed consent form (for publication) | L1_Study ICF Main Portuguese D0817C00098 Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_SVN ICF Country Main Slovenian D0817C00098 Public | 6.0 |
| Subject information and informed consent form (for publication) | L1_SWE Country ICF Main Appendix 1 Swedish D0817C00098 Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_SWE Country ICF Main Swedish D0817C00098 Public | 5.0 |
| Synopsis of the protocol (for publication) | D1_BEL Lay Protocol Synopsis Main Dutch D0817C00098 Public | 2.0 |
| Synopsis of the protocol (for publication) | D1_BEL Lay Protocol Synopsis Main French D0817C00098 Public | 2.0 |
| Synopsis of the protocol (for publication) | D1_BEL Lay Protocol Synopsis Main German D0817C00098 Public | 2.0 |
| Synopsis of the protocol (for publication) | D1_BGR Lay Protocol Synopsis Main Bulgarian D0817C00098 Public | 2.0 |
| Synopsis of the protocol (for publication) | D1_CZE Lay Protocol Synopsis Main Czech D0817C00098 Public | 2.0 |
| Synopsis of the protocol (for publication) | D1_ESP Lay Protocol Synopsis Main Spanish D0817C00098 Public | 2.0 |
| Synopsis of the protocol (for publication) | D1_FRA Lay Protocol Synopsis Main French D0817C00098 Public | 2.0 |
| Synopsis of the protocol (for publication) | D1_HUN Lay Protocol Synopsis Main Hungarian D0817C00098 Public | 2.0 |
| Synopsis of the protocol (for publication) | D1_ITA Lay Protocol Synopsis Main Italian D0817C00098 Public | 2.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Synopsis Main English D0817C00098 Public | 2.0 |
| Synopsis of the protocol (for publication) | D1_POL Lay Protocol Synopsis Main Polish D0817C00098 Public | 2.0 |
| Synopsis of the protocol (for publication) | D1_PRT Lay Protocol Synopsis Main Portuguese D0817C00098 Public | 2.0 |
| Synopsis of the protocol (for publication) | D1_SVN Lay Protocol Synopsis Main Slovenian D0817C00098 Public | 2.0 |
| Synopsis of the protocol (for publication) | D1_SWE Lay Protocol Synopsis Main Swedish D0817C00098 Public | 2.0 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-16 | Czechia | Acceptable with conditions 2024-08-13
|
2024-08-13 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-10-09 | Acceptable with conditions | 2024-11-19 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-01-09 | Acceptable with conditions | 2025-01-09 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-02-20 | Czechia | Acceptable with conditions | 2025-03-28 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-05-06 | Acceptable with conditions | 2025-05-28 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-03-11 | Czechia | Acceptable 2026-06-15
|
2026-06-15 |