Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
277
Countries
4
Sites
21
This is an extension study designed to provide continued treatment for eligible patients with cancer who were previously enrolled and treated in a Genentech/Roche study (the parent study), and do not have access to the treatment locally
1. To provide continued treatment with Roche investigational medicinal product (IMP)-based therapy and/or comparator agent(s) for eligible participants with cancer who are still on study treatment at the time of roll-over from the parent study and who do not have access to the study treatment locally
Key facts
- Sponsor
- F. Hoffmann-La Roche AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 25 May 2023 → ongoing
- Decision date (initial)
- 2024-01-08
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- F. Hoffmann-La Roche AG
External identifiers
- EU CT number
- 2023-504263-16-00
- EudraCT number
- 2022-003414-36
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Others
1. To provide continued treatment with Roche investigational medicinal product (IMP)-based therapy and/or comparator agent(s) for eligible participants with cancer who are still on study treatment at the time of roll-over from the parent study and who do not have access to the study treatment locally
Secondary objectives 1
- 1. To evaluate the safety and tolerability of the study treatment on the basis of the following endpoint: incidence, nature, and severity of selected adverse events as described in IMP-specific appendices
Conditions and MedDRA coding
This is an extension study designed to provide continued treatment for eligible patients with cancer who were previously enrolled and treated in a Genentech/Roche study (the parent study), and do not have access to the treatment locally
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Open label, Rollover study AN OPEN LABEL, MULTICENTER EXTENSION STUDY FOR PATIENTS PREVIOSULY ENROLLED IN A GENENTECH AND/OR F. HOFFMAN-LA ROCHE SPONSORED STUDY
|
Not Applicable | None |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- 1. Eligible for continuing Roche IMP-based therapy at the time of roll-over from the parent study, as per the parent study protocol or Eligible for continuing the comparator agent(s) in a Genentech- or Rochesponsored study as per the parent study protocol, with no access to commercially available comparator agent
- 2. First dose of study treatment in this extension study will be received within 7days of the treatment interruption window allowed by the parent study
- 3. Continue to benefit from the Roche IMP-based therapy or comparator at the time of roll-over from the parent study as assessed by the investigator, in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression after an integrated assessment of radiographic data, biopsy results (if available) and clinical status.
- 4. Negative urine pregnancy test within 24 hours prior to first dose administered on BX44273 study treatment in female participants of childbearing potential
- 5. Ability to comply with the extension study protocol, per Investigator's judgement
Exclusion criteria 6
- 1. Meet any of the study treatment discontinuation criteria specified in the parent study at the time of enrollment in this extension study
- 2. Study treatment or comparator agent is commercially marketed in the participant’s country for the participant-specific disease and is accessible to the participant
- 3. Treatment with any anti-cancer treatment (other than treatment permitted in the parent study) during the time between last treatment in the parent study and the first dose of study treatment in this extension study
- 4. Permanent discontinuation of all study treatment(s) or comparator agent(s) for any reason during the parent study or during the time between last treatment in the parent study and the first dose of study treatment in this extension study (if applicable)
- 5. Ongoing serious adverse event(s) that has not resolved to baseline level or Grade ≤ 1 from the parent study or during the time between the last treatment in the parent study and the first dose of study treatment in this extension study
- 6. Any condition that, in the opinion of the investigator, would interfere with the interpretation of participant safety or place the participant at high risk for treatmentrelated complications
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 1. Number of Participants with Continued Access to Roche IMP(s)-Based Therapy and/or Comparator Agent(s)
Secondary endpoints 1
- 1. The incidence, nature, and severity of selected adverse events as described in IMP-specific appendices
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 15
PRD9859715 · Product
- Active substance
- Ipatasertib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 1460 g gram(s)
- Max treatment duration
- 120 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
PRD9859714 · Product
- Active substance
- Ipatasertib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 1460 g gram(s)
- Max treatment duration
- 120 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
Tecentriq 1 200 mg concentrate for solution for infusion
PRD5434939 · Product
- Active substance
- Atezolizumab
- Substance synonyms
- RO5541267
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 1875 mg milligram(s)
- Max total dose
- 326.25 g gram(s)
- Max treatment duration
- 120 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FF05 — -
- Marketing authorisation
- EU/1/17/1220/001
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD9600625 · Product
- Active substance
- Atezolizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 g gram(s)
- Max treatment duration
- 1 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- ROCHE REGISTRATION GMBH (RRG)
- Paediatric formulation
- No
- Orphan designation
- No
Rozlytrek 200 mg hard capsules
PRD8236731 · Product
- Active substance
- Entrectinib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 2190 g gram(s)
- Max treatment duration
- 120 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EX14 — -
- Marketing authorisation
- EU/1/20/1460/002
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD11008928 · Product
- Active substance
- Entrectinib
- Pharmaceutical form
- COATED GRANULES
- Route of administration
- ORAL
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 2190 g gram(s)
- Max treatment duration
- 120 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
PRD10998736 · Product
- Active substance
- Entrectinib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 2190 g gram(s)
- Max treatment duration
- 120 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
PRD10998735 · Product
- Active substance
- Entrectinib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 2190 g gram(s)
- Max treatment duration
- 120 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
Rozlytrek 100 mg hard capsules
PRD8236780 · Product
- Active substance
- Entrectinib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 2190 g gram(s)
- Max treatment duration
- 120 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EX14 — -
- Marketing authorisation
- EU/1/20/1460/001
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD11081693 · Product
- Active substance
- Divarasib
- Other product name
- GDC-6036
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 0 DF dosage form
- Max total dose
- 0 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- GENENTECH, INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD11081694 · Product
- Active substance
- Divarasib
- Other product name
- GDC-6036
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 0 DF dosage form
- Max total dose
- 0 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- GENENTECH, INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD9793132 · Product
- Active substance
- Inavolisib
- Other product name
- GDC-0077
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 9 mg milligram(s)
- Max total dose
- 32.85 g gram(s)
- Max treatment duration
- 120 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
PRD9793811 · Product
- Active substance
- Inavolisib
- Other product name
- GDC-0077
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 9 mg milligram(s)
- Max total dose
- 32.85 g gram(s)
- Max treatment duration
- 120 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
Avastin 25 mg/ml concentrate for solution for infusion.
PRD2153902 · Product
- Active substance
- Bevacizumab
- Substance synonyms
- BI 695502, BS-503A, PF-06439535, BP01, HLX04, RHUMAB-VEGF, BEVACIZUMABUM, RHUMAB VEGF
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 15 mg/Kg milligram(s)/kilogram
- Max total dose
- 2595 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 120 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FG01 — -
- Marketing authorisation
- EU/1/04/300/002
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD7846761 · Product
- Active substance
- Tiragolumab
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 104.4 g gram(s)
- Max treatment duration
- 120 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
Auxiliary 1
SUB07361MIG · Substance
- Active substance
- Abiraterone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 1000 mg milligram(s)
- Max total dose
- 3650 g gram(s)
- Max treatment duration
- 120 Month(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
F. Hoffmann-La Roche AG
- Sponsor organisation
- F. Hoffmann-La Roche AG
- Address
- Grenzacherstrasse 124
- City
- Basel
- Postcode
- 4058
- Country
- Switzerland
Scientific contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Trial Information System - TISL
Public contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Trial Information System - TISL
Third parties 2
| Organisation | City, country | Duties |
|---|---|---|
| Almac Clinical Technologies LLC ORG-100043036
|
Souderton, United States | Interactive response technologies (IRT) |
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | Other |
Locations
4 EU/EEA countries · 21 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 5 | 3 |
| France | Ongoing, recruiting | 14 | 12 |
| Greece | Ongoing, recruiting | 3 | 2 |
| Poland | Ongoing, recruiting | 1 | 4 |
| Rest of world
Costa Rica, Korea, Republic of, United Kingdom, Japan, Mexico, Thailand, Taiwan, Russian Federation, Canada
|
— | 254 | — |
Investigational sites
UZ Leuven
Oncology, Herestraat 49, 3000, Leuven
Grand Hopital De Charleroi
Oncology, Rue Marguerite Depasse 6, 6060, Charleroi
Algemeen Ziekenhuis Groeninge
Urology, President Kennedylaan 4, 8500, Kortrijk
Centre Hospitalier Saint Joseph Saint Luc
Oncology, 20 Quai Claude Bernard, 69007, Lyon
Institut Gustave Roussy
Oncology, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Francois Baclesse
Oncology, 3 Avenue Du General Harris, Cs 45026, Caen Cedex 5
Centre Hospitalier Regional De Marseille
Oncology, 264 Rue Saint Pierre, 13005, Marseille
Institut Regional Du Cancer De Montpellier
Medical Oncology, 208 Avenue Des Apothicaires, 34298, Montpellier Cedex 5
Oncopole Claudius Regaud
Oncology, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Institut Curie
Oncology, 26 Rue D Ulm, 75005, Paris
Centre Hospitalier Universitaire De Nimes
Medical Oncology, 4 Place Du Professeur Robert Debre, Bp 40026, Nimes Cedex 9
Institut De Cancerologie De L Ouest
Oncologie médicale, Boulevard Jacques Monod, 44805, Saint-Herblain Cedex
Institut De Cancerologie De Bourgogne
Oncology, 18 Cours General De Gaulle, 21000, Dijon
Assistance Publique Hopitaux De Paris
Oncology, 4 Rue De La Chine, 75020, Paris
Institut Bergonie
Oncology, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
Metropolitan General Hospital Healthcare Facilities Operation And Management Single Member S.A.
Oncology Clinical Trials & Research Clinic, Leoforos Mesogeion 264, 155 62, Cholargos
Geniko Nosokomeio Thessalonikis George Papanikolaou
Pulmonary Clinic, Exochi, 570 10, Thessaloniki
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Klinika Nowotworów Tkanek Miękkich, Kości i Czerniaków, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Pratia S.A.
Centrum Medyczne Pratia Poznań, Ul. Gryfinska 1, 60-192, Poznan
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
Oddział Dzienny Chemioterapii, Ul. Tytusa Chalubinskiego 7, 75-581, Koszalin
Uniwersyteckie Centrum Kliniczne
Ośrodek Badań Klinicznych Wczesnych Faz, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
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 | 2023-05-25 | 2023-06-01 | |||
| France | 2023-12-19 | 2024-01-25 | |||
| Greece | 2025-07-01 | 2025-07-28 | |||
| Poland | 2026-01-23 | 2026-02-04 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 68 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-504263-16-00 Redacted | 6 |
| Protocol (for publication) | d1_protocol-2023-504263-16-00-redacted_gr | 6 |
| Recruitment arrangements (for publication) | K Recruitment arragement | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 6.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2 |
| Recruitment arrangements (for publication) | K3_Document additionnel | 1 |
| Subject information and informed consent form (for publication) | L Subject information and informed consent form IAF | 3 |
| Subject information and informed consent form (for publication) | L Subject information and informed consent form Main_FILE NOTE | NA |
| Subject information and informed consent form (for publication) | L Subject information and informed consent form PPA | 3 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Main Atezolizumab_REDACTED | 5 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Main Ipatasertib_REDACTED | 6 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Main Tiragolumab_Atezolizumab_REDACTED | 5 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Main_Entrectinib | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Add BX44273 - BO39610 AB Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Add BX44273 - CO39303_FR | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Add BX44273 - MO39874 A Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Add BX44273 - WO39613 AT Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Add BX44273 - WO42017 AT Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Add BX44273 - WO42178 ABC Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Add BX44273 - WO42178 IB | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF IAF | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Infant Authorization Form_EN | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Infant Authorization Form_FR | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Infant Authorization Form_NL | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Infant_FR | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main BX44273 - BO29554 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main BX44273 - BO39610 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main BX44273 - BO39633 A Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main BX44273 - BO41932 E Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main BX44273 - CO39303_FR | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main BX44273 - GO40782 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main BX44273 - MO39193_FR | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main BX44273 - MO39874_FR | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main BX44273 - WO39613 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main BX44273 - WO42017_FR | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main BX44273 - WO42178 ABC | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main BX44273 - WO42178 IB | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Divarasib_REDACTED | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main ICF Atezolizumab_EN_REDACTED | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main ICF Atezolizumab_FR_REDACTED | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main ICF Atezolizumab_NL_REDACTED | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main ICF_EN_REDACTED | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main ICF_FR_REDACTED | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main ICF_NL_REDACTED | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Atezo_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Tira_Atezo_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PPA | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner Authorization_EN | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner Authorization_FR | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner Authorization_NL | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_FR | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Entrectinib_13-18 years | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Entrectinib_3-7 years | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Entrectinib_7-13 years | 1 |
| Subject information and informed consent form (for publication) | L2_Informed Consent Form Procedure | 3.0 |
| Subject information and informed consent form (for publication) | L2_Sponsor Statement On Use Of ICF Model | 1 |
| Subject information and informed consent form (for publication) | L3_Recruitment and Informed consent procedure | 1 |
| Subject information and informed consent form (for publication) | L4_Carte participant | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | g2_smpc-bevacizumab | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | g2_smpc-entrectinib | N/A |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BE-DE 2023-504263-16-00 | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BE-FR 2023-504263-16-00 | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BE-NL 2023-504263-16-00 | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ENG 2023-504263-16-00 | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR-FR 2023-504263-16-00 | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_PL-PL 2023-504263-16-00 | 1.0 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_gr_2023-504263-16-00 | 1.0 |
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-16 | Belgium | Acceptable 2024-01-08
|
2024-01-08 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-07 | Belgium | Acceptable with conditions 2024-08-23
|
2024-08-23 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-09-24 | Belgium | Acceptable 2024-11-18
|
2024-11-18 |
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2025-02-03 | 2025-04-29 | ||
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-05-23 | Belgium | Acceptable 2025-08-04
|
2025-08-04 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-09-24 | Belgium | Acceptable 2025-10-31
|
2025-10-31 |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-12-15 | Belgium | Acceptable 2026-03-24
|
2026-03-24 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-04-17 | Acceptable 2026-03-24
|
2026-04-17 | |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-04-17 | Acceptable 2026-03-24
|
2026-04-17 |