Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruitment ended
Participants planned
52
Countries
7
Sites
32
Glioma
The purpose of this study is to measure the benefit of adding abemaciclib to the chemotherapy, temozolomide, for newly diagnosed high-grade glioma following radiotherapy.
Key facts
- Sponsor
- Eli Lilly & Co.
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years, 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 24 Sep 2024 → ongoing
- Decision date (initial)
- 2024-08-06
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-502269-13-00
- WHO UTN
- U1111-1289-0405
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy, Pharmacokinetic, Safety
The purpose of this study is to measure the benefit of adding abemaciclib to the chemotherapy, temozolomide, for newly diagnosed high-grade glioma following radiotherapy.
Conditions and MedDRA coding
Glioma
Regulatory references
- EMA paediatric investigation plan (PIP)
- EMEA-002342-PIP02-18
- Plan to share IPD
- Yes
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-506778-11-00 | I3Y-MC-JPCS: A Phase 1b/2 Study of Abemaciclib in Combination with Irinotecan and Temozolomide (Part A) and Abemaciclib in Combination with Temozolomide (Part B) in Pediatric and Young Adult Patients with Relapsed/Refractory Solid Tumors and Abemaciclib in Combination with Dinutuximab, GM-CSF, Irinotecan, and Temozolomide in Pediatric and Young Adult Patients with Relapsed/Refractory Neuroblastoma (Part C). | Eli Lilly & Co. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Participants must:
- Have high-grade glioma
- Have had prior radiotherapy with or without temozolomide (patients less than 3 years old without prior radiotherapy may be eligible)
- Have recovered from major side effects of previous therapy and have adequate organ function and blood counts, as measured by lab tests
- Be able to swallow or have a feeding tube
- Be willing and able to follow study procedures, including frequent lab tests and tumor imaging
Exclusion criteria 6
- Participants must not:
- Have glioma that came back or started growing again after receiving treatment
- Have received other therapy for this cancer, except surgery and radiotherapy (with or without temozolomide)
- Have certain alterations in their tumor that can be treated with a different therapy
- Have acute infections or any serious medical conditions (other than this cancer)
- Be pregnant or breastfeeding
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Event Free Survival as Determined by Blinded Independent Review Committee
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
PRD10495613 · Product
- Active substance
- Abemaciclib
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD10495615 · Product
- Active substance
- Abemaciclib
- Pharmaceutical form
- GRANULES
- Route of administration
- ORAL USE
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- Yes
- Orphan designation
- No
Verzenios 50 mg film-coated tablets
PRD6701098 · Product
- Active substance
- Abemaciclib
- Substance synonyms
- LY2835219
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EF03 — -
- Marketing authorisation
- EU/1/18/1307/001
- MA holder
- ELI LILLY NEDERLAND B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Different primary packaging (bottles) than in marketing authorisation and clinical trial specific packaging and labeling.
Comparator 1
SCP131007 · ATC
- Active substance
- Temozolomide
- Route of administration
- ORAL USE
- Max daily dose
- 200 mg/m2 milligram(s)/sq. meter
- Max total dose
- 28600 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01AX03 — TEMOZOLOMIDE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Eli Lilly & Co.
- Sponsor organisation
- Eli Lilly & Co.
- Address
- 1 Lilly Corporate Center
- City
- Indianapolis
- Postcode
- 46285-0001
- Country
- United States
Scientific contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Lilly Clinical Trials information desk
Public contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Lilly Clinical Trials information desk
Third parties 8
| Organisation | City, country | Duties |
|---|---|---|
| Jumo Health USA Inc. ORG-100044054
|
New Haven, United States | Other |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| Altasciences Compagnie Inc. ORG-100037610
|
Laval, Canada | Laboratory analysis |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | On site monitoring, Code 10, Code 11, Code 12, Code 13, Other, Other, Code 2, Laboratory analysis, Code 5, Data management, E-data capture |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Other |
| PPD Development L.P. ORG-100011560
|
Wilmington, United States | Code 10 |
| Labcorp Early Development Laboratories Inc. ORG-100012865
|
Indianapolis, United States | Laboratory analysis |
| Q2 Solutions LLC ORG-100017000
|
Ithaca, United States | Laboratory analysis |
Locations
7 EU/EEA countries · 32 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 3 | 4 |
| Denmark | Ongoing, recruitment ended | 2 | 1 |
| France | Ongoing, recruitment ended | 6 | 8 |
| Italy | Ongoing, recruitment ended | 8 | 7 |
| Netherlands | Ongoing, recruitment ended | 2 | 1 |
| Romania | Ongoing, recruitment ended | 2 | 2 |
| Spain | Ongoing, recruitment ended | 7 | 9 |
| Rest of world
Japan, United States, Australia
|
— | 22 | — |
Investigational sites
Centre Hospitalier Regional De La Citadelle
Pediatric hemato-oncology department, Boulevard Du Douzieme De Ligne 1, 4000, Liege
UZ Leuven
Pediatric hemato-oncology department, Herestraat 49, 3000, Leuven
Universitair Ziekenhuis Gent
Pediatric hemato- oncology department, Corneel Heymanslaan 10, 9000, Gent
Cliniques Universitaires Saint-Luc
Pediatric hemato-oncology department, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Rigshospitalet
Department of Paediatrics and Adolescent Medicine, Blegdamsvej 9, 2100, Copenhagen Oe
Institut Curie
SIREDO(Soins, Innovation, Recherche, en oncologie de l’Enfant, de l’aDOlescent et de l’adulte jeune), 26 Rue D Ulm, 75005, Paris
Centre Leon Berard
IHOPe (Institute of Hematology and Pediatric Oncology), 28 Rue Laennec, 69008, Lyon
Centre Oscar Lambret
Pediatric unit, oncology department, 3 Rue Frederic Combemale, 59000, Lille
CHRU De Nancy
Paediatric onco-haematology unit, Rue Du Morvan, 54500, Vandoeuvre Les Nancy
Institut Gustave Roussy
Children and adolescent oncology, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Hospitalier Universitaire De Bordeaux
Paediatric onco-haematology unit, Place Amelie Raba Leon, 33000, Bordeaux
Centre Hospitalier Regional De Marseille
Service d’immunologie, hématologie et oncologie pédiatrique, 264 Rue Saint Pierre, 13005, Marseille
Centre Hospitalier Universitaire D'Angers
Pediatric Oncology, 4 Rue Larrey, 49100, Angers
Istituto Oncologico Veneto
Medical Oncology 1 Unit, Via Gattamelata 64, 35128, Padova
Bambino Gesu Childrens Hospital
Neuro-Oncology Unit, Piazza Sant'Onofrio 4, 00165, Rome
Fondazione IRCCS Istituto Nazionale Dei Tumori
Pediatric Oncology Unit, Via Giacomo Venezian 1, 20133, Milan
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
SC Pediatric Oncoematology, Piazza Polonia 94, 10126, Turin
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UO Oncologia Pediatrica, Largo Francesco Vito 1, 00168, Rome
L’Azienda Ospedaliera Di Rilievo Nazionale Santobono-Pausilipon
UOSD Neuroncology, Via Posillipo 226, 80123, Naples
IRCCS Istituto Giannina Gaslini
Department of Hemato-Oncology, Via Gerolamo Gaslini 5, 16147, Genoa
Prinses Maxima Centrum voor Kinderoncologie B.V.
Neuro-oncology, Heidelberglaan 25, 3584 CS, Utrecht
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Sectia Oncopediatrie, Strada Republicii 34-36, 400015, Cluj-Napoca
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
Sectia Oncologie Pediatrica, Soseaua Fundeni 252, 022328, Bucharest
Hospital Universitari Vall D Hebron
Servei d’Oncologia i Hematologia Pediatrica, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Y Politecnico La Fe
Unidad Oncohematología Pediátrica, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario Reina Sofia
Servicio de Pediatría, Avenida Menendez Pidal S/n, 14004, Cordoba
Hospital Universitario Hm Monteprincipe
Pediatric Oncology Unit, Avenida De Monteprincipe 25, 28660, Boadilla Del Monte
Hospital Infantil Universitario Nino Jesus
Servicio de Onco-Hematología Pediátrica, Avenida Menendez Pelayo 65, 28009, Madrid
Hospital Universitario La Paz
Hemato-Oncología Pediátrica y TPH, Paseo De La Castellana 261, 28046, Madrid
University Clinical Hospital Virgen De La Arrixaca
Oncología pediatrica, Carretera Madrid-Cartagena S/N, El Palmar, Murcia
Sant Joan De Deu Barcelona Hospital
Unidad de Neuro-Oncología, Passeig De Sant Joan De Deu 2, 08950, Esplugues De Llobregat
University Hospital Virgen Del Rocio S.L.
Oncología pediatrica, Avenida De Manuel Siurot S/n, 41013, Sevilla
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 | 2025-01-28 | 2025-09-04 | 2026-01-14 | ||
| Denmark | 2025-03-24 | 2025-06-13 | 2026-01-14 | ||
| France | 2024-10-03 | 2025-02-24 | 2026-01-14 | ||
| Italy | 2024-10-02 | 2025-04-03 | 2026-01-14 | ||
| Netherlands | 2025-05-27 | 2025-06-20 | 2026-01-14 | ||
| Romania | 2025-04-23 | 2025-08-05 | 2026-01-14 | ||
| Spain | 2024-09-24 | 2024-10-25 | 2026-01-14 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 111 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2022-502269-13-00_FP | a |
| Protocol (for publication) | D4_Patient Facing Documentation Statement_FP | 1.0 |
| Recruitment arrangements (for publication) | K1_ICF and Patient Recruitment Procedure_FP | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruit-ICF process_FP | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruit-ICF process_FP | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruit-ICF process_FP | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruit-ICF process_FP | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruit-ICF process_Placeholder_FP | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_FP | 1.1 |
| Recruitment arrangements (for publication) | K2_Appointment Reminder Card_en_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Appointment Reminder Card_ro_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Brochure_en_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Brochure_en_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Brochure_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Brochure_FP | 1.1 |
| Recruitment arrangements (for publication) | K2_Brochure_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Brochure_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Brochure_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Brochure_fr_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Brochure_nl_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Brochure_ro_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_HCP Letter_en_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_HCP Letter_ro_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_HCP_FS_en_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_HCP_FS_ro_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Lay synopsis for website_PMC_FP | N/A |
| Recruitment arrangements (for publication) | K2_Patient Letter_en_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Patient letter_en_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Patient Letter_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Patient Letter_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Patient Letter_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Patient Letter_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Patient letter_fr_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Patient letter_nl_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Patient Letter_ro_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Poster_en_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Poster_en_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Poster_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Poster_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Poster_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Poster_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Poster_fr_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Poster_nl_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Poster_ro_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Study Visit Guide_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_SVG_en_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_SVG_ro_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Parental-Adult Main_sponsor statement_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Adult and Parent Privacy_FP | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Adult_FP | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Assent 12-14y_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Assent 12-17 years_FP | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Assent 15-17y_FP | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Assent 2-6 years_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Assent 6-11_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Assent 7-11 years_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Assent older 12-AoM_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Assent Older Age_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Assent older_en_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Assent older_en_FP | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Assent older_fr_FP | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Assent older_nl_FP | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Assent older_ro_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Assent younger age_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Assent Younger Age_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Assent younger_en_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Assent younger_en_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Assent younger_fr_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Assent younger_nl_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Assent younger_ro_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Consent 12-16_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Greenphire Notice_en_FP | 10.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Greenphire Notice_fr_FP | 10.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Greenphire Notice_nl_FP | 10.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Greenphire_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main 16plus_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main_FP | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Optional Biopsy_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Parent_FP | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Parent_FP | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Parental Guardian_FP | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Parental Optional Biopsy_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Parental-Adult Main_en_FP | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Parental-Adult Main_en_FP | 10.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Parental-Adult Main_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Parental-Adult Main_FP | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Parental-Adult Main_FP | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Parental-Adult Main_fr_FP | 10.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Parental-Adult Main_nl_FP | 10.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Parental-Adult Main_ro_FP | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_PP_en_FP | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_PP_FP | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_PP_fr_FP | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_PP_nl_FP | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Preg Partner_en_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Preg Partner_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Preg Partner_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Preg Partner_ro_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Pregnant Partner and Participant_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Pregnant Partner_FP | 3.0 |
| Subject information and informed consent form (for publication) | L2_Parent PoA_FP | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_temozolomide_FP | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BE_de_2022-502269-13-00_FP | a |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BE_fr_2022-502269-13-00_FP | a |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BE_nl_2022-502269-13-00_FP | a |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_EN_2022-502269-13-00_FP | a |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ES_es_2022-502269-13-00_FP | a |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_FR_fr_2022-502269-13-00_FP | a |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_IT_it_2022-502269-13-00_FP | a |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_NL_nl_2022-502269-13-00_FP | a |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_RO_ro_2022-502269-13-00_FP | a |
Application history
14 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-29 | Spain | Acceptable 2024-08-05
|
2024-08-05 |
| 2 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-09-05 | Spain | Acceptable 2024-11-11
|
2024-11-13 |
| 3 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-12-05 | Spain | Acceptable | 2025-01-16 |
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2024-12-06 | Acceptable 2024-11-11
|
2025-02-21 | |
| 5 | SUBSEQUENT ADDITION OF MSC | APP-5 | 2024-12-06 | Acceptable 2024-11-11
|
2025-03-17 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-12-10 | Acceptable | 2025-03-14 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-8 | 2024-12-11 | Acceptable | 2024-12-20 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-9 | 2024-12-13 | Acceptable | 2025-02-03 | |
| 9 | SUBSEQUENT ADDITION OF MSC | APP-9 | 2025-01-30 | Acceptable 2024-11-11
|
2025-04-24 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-10 | 2025-05-15 | Spain | Acceptable 2025-06-23
|
2025-06-26 |
| 11 | SUBSTANTIAL MODIFICATION | SM-11 | 2025-11-26 | Acceptable | 2026-02-25 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-12 | 2025-11-26 | Acceptable | 2026-01-16 | |
| 13 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-03-25 | Spain | Acceptable | 2026-03-25 |
| 14 | SUBSTANTIAL MODIFICATION | SM-13 | 2026-04-15 | Spain | Acceptable | 2026-05-15 |