Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ended
Participants planned
67
Countries
4
Sites
13
Advanced or Metastatic Breast Cancer
Phase 1b: To assess safety and tolerability of ARV-471 in combination with samuraciclib in participants with ER+/HER2- A/MBC to select up to 2 RDEs for the combination. Phase 2: To assess the clinical antitumor activity of ARV-471 in combination with samuraciclib. DDI Assessment Cohort(s): To evaluate the effect of sam…
Key facts
- Sponsor
- Pfizer Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 25 Mar 2024 → 26 Nov 2025
- Decision date (initial)
- 2024-02-28
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Pfizer Inc
External identifiers
- EU CT number
- 2023-507125-41-00
- ClinicalTrials.gov
- NCT06125522
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic, Others, Efficacy, Safety
Phase 1b: To assess safety and tolerability of ARV-471 in combination with samuraciclib in participants with ER+/HER2- A/MBC to select up to 2 RDEs for the combination.
Phase 2: To assess the clinical antitumor activity of ARV-471 in combination with samuraciclib.
DDI Assessment Cohort(s): To evaluate the effect of samuraciclib on PK of ARV-471, To evaluate the effect of ARV-471 on PK of samuraciclib.
Secondary objectives 9
- Phase 1b: To evaluate the overall safety profile.
- Phase 1b: To evaluate antitumor activity of ARV-471 in combination with samuraciclib.
- Phase 1b: To evaluate the plasma exposure of ARV-471, ARV-473, and samuraciclib when ARV-471 and samuraciclib are given in combination.
- Phase 2: To determine additional antitumor activity outcomes of ARV-471 in combination with samuraciclib.
- Phase 2: To further characterize the overall safety profile and tolerability of ARV-471 in combination with samuraciclib.
- Phase 2: To evaluate the plasma exposure of ARV-471, ARV-473 and samuraciclib when ARV-471 and samuraciclib are given in combination.
- Phase 2: To assess changes from baseline levels in plasma ctDNA with treatment.
- Phase 2: To evaluate the correlation between TP53 mutation status and antitumor activity.
- DDI Assessment Cohort(s): To evaluate the overall safety profile
Conditions and MedDRA coding
Advanced or Metastatic Breast Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10072737 | Advanced breast cancer | 10029104 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Participants must be patients with ER+/HER2- A/MBC, who have been previously treated with up to 2 lines of prior therapies for advanced/metastatic disease including 1 line of any prior CDK4/6 inhibitor-based regimen. The current A/MBC disease must have at least 1 measurable lesion as per RECIST v1.1.
Exclusion criteria 5
- Participants in visceral crisis at risk of life-threatening complications in the short term
- Participants with active bleeding, history of hemolytic anemia or marrow aplasia.
- Participants with newly diagnosed brain metastases
- Refractory nausea and vomiting and other gastrointestinal (GI) conditions precluding adequate absorption of study interventions
- History of any other malignancies within the past three years, except for (1) adequately treated basal or squamous cell carcinoma of the skin and (2) curatively treated in situ carcinoma of the cervix.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 3
- Phase 1b: DLTs during DLT observation period (Cycle 1).
- Phase 2: Confirmed OR (CR or PR) determined by investigator assessment.
- DDI Assessment Cohort(s): Steady-state AUCtau and Cmax of ARV-471 with and without coadministration of samuraciclib, Single dose AUC0-72 and Cmax of samuraciclib with and without coadministration of ARV-471.
Secondary endpoints 9
- Phase 1b: • Incidence of AEs and SAEs. • Incidence of laboratory abnormalities. • Incidence of ECG abnormalities
- Phase 1b: • Confirmed OR (CR or PR) by investigator assessment. • DoR by investigator assessment. • CBR (confirmed CR or PR at any time, or SD ≥24 weeks) by investigator assessment. • PFS by investigator assessment.
- Phase 1b: Plasma concentrations of ARV-471, ARV-473, and samuraciclib.
- Phase 2: • DoR by investigator assessment. • CBR (confirmed CR or PR at any time or SD ≥24 weeks) by investigator assessment. • PFS by investigator assessment. • OS.
- Phase 2: • Incidence of AEs and SAEs. • Incidence of laboratory abnormalities. • Incidence of ECG abnormalities.
- Phase 2: Plasma concentrations of ARV-471, ARV-473 and samuraciclib.
- Phase 2: ctDNA plasma quantitative changes from pre-treatment to evaluate potential predictability of their associations with clinical outcomes.
- Phase 2: TP53 status defined from analysis of baseline ctDNA.
- DDI Assessment Cohort(s): Incidence of AEs and SAEs, Incidence of laboratory abnormalities, Incidence of ECG abnormalities.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD5244680 · Product
- Active substance
- Samuraciclib
- Substance synonyms
- CT7001, (3R,4R)-4-(((3-(1-METHYLETHYL)-7-((PHENYLMETHYL)AMINO)PYRAZOLO(1,5-A)PYRIMIDIN-5-YL)AMINO)METHYL)-3-PIPERIDINOL, CT-7001, ICEC0942, (3R,4R)-4-(((7-(BENZYLAMINO)-3-(PROPAN-2-YL)PYRAZOLO(1,5-A)PYRIMIDIN-5-YL)AMINO)METHYL)PIPERIDIN-3-OL
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Authorisation status
- Not Authorised
- MA holder
- CARRICK THERAPEUTICS LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD9906032 · Product
- Active substance
- (3S-3-6-4-1-4-1R2S-6-HYDROXY-2-PHENYL-1234-TETRAHYDRONAPHTHALEN-1-YLPHENYLPIPERIDIN-4-YLMETHYLPIPERAZIN-1-YL-3-OXO-1H-ISOINDOL-2-YLPIPERIDINE-26-DIONE
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Authorisation status
- Not Authorised
- MA holder
- PFIZER INC.
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Pfizer Inc.
- Sponsor organisation
- Pfizer Inc.
- Address
- 66 Hudson Boulevard East
- City
- New York
- Postcode
- 10001-2189
- Country
- United States
Scientific contact point
- Organisation
- Pfizer Inc.
- Contact name
- Clinical Medical Lead
Public contact point
- Organisation
- Pfizer Inc.
- Contact name
- Clinical Medical Lead
Third parties 3
| Organisation | City, country | Duties |
|---|---|---|
| PPD Global Limited ORG-100007533
|
Cambridge, United Kingdom | On site monitoring |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| Pharmaceutical Product Development LLC ORG-100016999
|
Highland Heights, United States | Other |
Locations
4 EU/EEA countries · 13 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 8 | 2 |
| France | Ended | 12 | 4 |
| Italy | Ended | 12 | 3 |
| Spain | Ended | 16 | 4 |
| Rest of world
Canada, Puerto Rico, United States
|
— | 19 | — |
Investigational sites
Institut Jules Bordet
N/A, Mijlenmeersstraat 90, 1070, Anderlecht
Antwerp University Hospital
Oncology, Drie Eikenstraat 655, 2650, Edegem
Institut Gustave Roussy
DITEP, 114 Rue Edouard Vaillant, 94800, Villejuif
Centr Georges Francois Leclerc
Oncologie Médicale, 1 Rue Professeur Marion, 21000, Dijon
Institut De Cancerologie De L Ouest
Oncologie Médicale, Bd Du Professeur Jacques Monod, 44800, St Herblain
Institut Regional Du Cancer De Montpellier
Oncologie Médicale, 208 Avenue Des Apothicaires, 34298, Montpellier Cedex 5
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Unità di Fase 1: Unità di Farmacologia Clinica, Largo Francesco Vito 1, 00168, Rome
Fondazione IRCCS San Gerardo Dei Tintori
Centro di Ricerca di Fase 1, Via Giovanni Battista Pergolesi 33, 20900, Monza
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Oncologia medica, Via Piero Maroncelli 40, 47014, Meldola
Hospital Universitario 12 De Octubre
N/A, Bloque D, Avenida De Cordoba Sn, Madrid
University Hospital Virgen Del Rocio S.L.
N/A, Avenida De Manuel Siurot S/n, 41013, Sevilla
Universidad De Navarra
N/A, Pio XII Etorbidea 55, 31008, Pamplona
Hospital Universitari Vall D Hebron
Departamento de Oncologia- VHIO, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
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 | 2024-03-25 | 2024-05-08 | |||
| France | 2024-07-10 | 2024-09-04 | |||
| Italy | 2024-04-30 | 2025-11-26 | 2024-05-30 | 2025-02-21 | |
| Spain | 2024-05-22 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 122 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1 Protocol 2023-507125-41-00_C4891024_redline | PA2 |
| Protocol (for publication) | D1_PACL_ECC Med Escalation Process Change_2023-507125-41_C4891024_Public | 1 |
| Protocol (for publication) | D1_Protocol_2023-507125-41-00_C4891024_Public | PA2 |
| Protocol (for publication) | D6 Patient-facing material _ePRO_EQ-5D-5L Paper Self- Complete_BE_EN_C4891024_public | 1.1 |
| Protocol (for publication) | D6_Patient-facing material _ePRO_EQ-5D-5L Paper Self-Complete_BE_DUT_C4891024_public | 1.2 |
| Protocol (for publication) | D6_Patient-facing material _ePRO_EQ-5D-5L Paper Self-Complete_BE_FR_C4891024_public | 1.1 |
| Protocol (for publication) | D6_Patient-facing material _ePRO_EQ-5D-5L Paper Self-Complete_ES_C4891024_public | 1 |
| Protocol (for publication) | D6_Patient-facing material _ePRO_EQ-5D-5L Paper Self-Complete_FR_C4891024_public | 1.2 |
| Protocol (for publication) | D6_Patient-facing material _ePRO_EQ-5D-5L Paper Self-Complete_IT_C4891024_public | 1.1 |
| Protocol (for publication) | D7_Patient-facing material _ePRO_QLQ-C30_BE_DUT_C4891024_public | 3 |
| Protocol (for publication) | D7_Patient-facing material _ePRO_QLQ-C30_BE_EN_C4891024 _public | 3 |
| Protocol (for publication) | D7_Patient-facing material _ePRO_QLQ-C30_BE_FR_C4891024_public | 3 |
| Protocol (for publication) | D7_Patient-facing material _ePRO_QLQ-C30_ES_C4891024_public | 3 |
| Protocol (for publication) | D7_Patient-facing material _ePRO_QLQ-C30_FR_C4891024_public | 3 |
| Protocol (for publication) | D7_Patient-facing material _ePRO_QLQ-C30_IT_C4891024_public | 3 |
| Protocol (for publication) | D8_Patient-facing material_Dosing diary_C1 and 2_BE_EN_C4891024_public | 1 |
| Protocol (for publication) | D8_Patient-facing material_Dosing Diary_C1 and 2_Multiple_Public | 2.0 |
| Protocol (for publication) | D8_Patient-facing material_Dosing diary_C1+2_BE_DUT_C4891024_public | 1 |
| Protocol (for publication) | D8_Patient-facing material_Dosing diary_C1+2_BE_FR_C4891024_public | 1 |
| Protocol (for publication) | D8_Patient-facing material_Dosing diary_C1+2_ES_C4891024_public | 1 |
| Protocol (for publication) | D8_Patient-facing material_Dosing diary_C1+2_FR_C4891024_public | 1 |
| Protocol (for publication) | D8_Patient-facing material_Dosing diary_C1+2_IT_C4891024_public | 1 |
| Protocol (for publication) | D8_Patient-facing material_Dosing diary_C3_BE_DUT_C4891024_public | 1 |
| Protocol (for publication) | D8_Patient-facing material_Dosing diary_C3_BE_EN_C4891024_public | 1 |
| Protocol (for publication) | D8_Patient-facing material_Dosing diary_C3_BE_FR_C4891024_public | 1 |
| Protocol (for publication) | D8_Patient-facing material_Dosing diary_C3_ES_C4891024_public | 1 |
| Protocol (for publication) | D8_Patient-facing material_Dosing diary_C3_FR_C4891024_public | 1 |
| Protocol (for publication) | D8_Patient-facing material_Dosing diary_C3_IT_C4891024_public | 1 |
| Protocol (for publication) | D8_Patient-facing material_Dosing Diary_C3_Multiple_Public | 2.0 |
| Protocol (for publication) | D8_Patient-facing material_Dosing diary_Lead-in_Phase_BE_DUT_C4891024_public | 1 |
| Protocol (for publication) | D8_Patient-facing material_Dosing diary_Lead-in_Phase_BE_EN_C4891024_public | 1 |
| Protocol (for publication) | D8_Patient-facing material_Dosing diary_Lead-in_Phase_BE_FR_C4891024_public | 1 |
| Protocol (for publication) | D8_Patient-facing material_Dosing diary_Lead-in_Phase_ES_C4891024_public | 1 |
| Protocol (for publication) | D8_Patient-facing material_Dosing diary_Lead-in_Phase_FR_C4891024_public | 1 |
| Protocol (for publication) | D8_Patient-facing material_Dosing diary_Lead-in_Phase_IT_C4891024_public | 1 |
| Protocol (for publication) | D8_Patient-facing material_Dosing Diary_Lead-in_Phase_Multiple_Public | 2.0 |
| Recruitment arrangements (for publication) | K0a C4891024_Recruitment Consent Procedure_IT_EN_Public | 2 |
| Recruitment arrangements (for publication) | K1 C4891024_Recruitment and Informed Consent Procedure_EN_31Jan2024_TC_Public | 2 |
| Recruitment arrangements (for publication) | K1 C4891024_Recruitment and Informed Consent Procedure_EN_Public | 2 |
| Recruitment arrangements (for publication) | K1 C4891024_Recruitment and Informed Consent Procedure_Public | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment Material_C4891024_Pfizer Breast Cancer_ClinicalTrial_IT IT | 1 |
| Recruitment arrangements (for publication) | K1a C4891024_Recruitment and Informed Consent Procedure_EN_TC_Public | 2 |
| Recruitment arrangements (for publication) | K1a C4891024_Recruitment consent Procedure_FR_Public | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_C4891024_Breast Cancer_Homepage_FR FR_Public | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_C4891024_Pfizer Breast Cancer_GeneralFAQs_IT IT | 1 |
| Recruitment arrangements (for publication) | K3_Recruitment Material_C4891024_Breast Cancer_StepsToJoin_FR FR_Public | 1 |
| Recruitment arrangements (for publication) | K3_Recruitment Material_C4891024_Pfizer Breast Cancer_Homepage_IT IT | 1 |
| Recruitment arrangements (for publication) | K4_Recruitment Material_C4891024_Breast Cancer_GeneralFAQs_FR FR_Public | 1 |
| Recruitment arrangements (for publication) | K4_Recruitment Material_C4891024_Pfizer Breast Cancer_Landing Page_IT IT | 1 |
| Recruitment arrangements (for publication) | K5_Recruitment Material_C4891024_ Breast Cancer_Landing Page_FR FR_Public | 1 |
| Recruitment arrangements (for publication) | K5_Recruitment Material_C4891024_Pfizer Breast Cancer_Privacy_IT IT | 1 |
| Recruitment arrangements (for publication) | K6_Recruitment Material_C4891024_Breast Cancer_Privacy_FR FR_Public | 1.1 |
| Recruitment arrangements (for publication) | K6_Recruitment Material_C4891024_Pfizer Breast Cancer_StepsToJoin_IT IT | 1 |
| Recruitment arrangements (for publication) | K7_Recruitment Material_C4891024_Breast Cancer_Privacy_FR FR_Public | 1 |
| Recruitment arrangements (for publication) | K7_Recruitment Materials_C4891024_Pfizer Breast Cancer_ProgStudyPag_IT_IT | 1.0 |
| Recruitment arrangements (for publication) | K8_Recruitment Material_C4891024_Breast Cancer_ClinicalTrials_FR FR_Public | 1 |
| Recruitment arrangements (for publication) | K9_Recruitment Material_C4891024_Breast_Cancer_ProgStudyPag_FR_FR_Public | 1 |
| Subject information and informed consent form (for publication) | L1 C4891024_Addendum for Treatment Beyond Progression ICD_EN_Public | 2 |
| Subject information and informed consent form (for publication) | L1 C4891024_Addendum for Treatment Beyond Progression ICD_EN_TC_Public | 2 |
| Subject information and informed consent form (for publication) | L1 C4891024_Main Country ICD_ES_TC | 3 |
| Subject information and informed consent form (for publication) | L10 C4891024_Main Country ICD DDI_EN_Public | 3 |
| Subject information and informed consent form (for publication) | L11 C4891024_Main Country ICD DDI _BE_NL_TC | 1 |
| Subject information and informed consent form (for publication) | L11 C4891024_Main Country ICD_BE_NL_Public | 3 |
| Subject information and informed consent form (for publication) | L12 C4891024_Main Country ICD DDI_BE_FR_TC | 2 |
| Subject information and informed consent form (for publication) | L12 C4891024_Main Country ICD_BE_FR_Public | 3 |
| Subject information and informed consent form (for publication) | L13 C4891024_Scout ICD_EN_Public | 2 |
| Subject information and informed consent form (for publication) | L13 C4891024_Scout ICD_EN_V2_TC_Public | 2 |
| Subject information and informed consent form (for publication) | L14 C4891024_Scout ICD_BE_NL_Public | 2 |
| Subject information and informed consent form (for publication) | L14 C4891024_Scout ICD_BE_NL_TC_Public | 2 |
| Subject information and informed consent form (for publication) | L15 C4891024_Scout ICD_BE_FR_Public | 2 |
| Subject information and informed consent form (for publication) | L15 C4891024_Scout ICD_BE_FR_TC_Public | 2 |
| Subject information and informed consent form (for publication) | L16 C4891024_Main ICD_Phase Ib_EN_Public | 2 |
| Subject information and informed consent form (for publication) | L16 C4891024_Main ICD_Phase Ib_EN_TC | 1 |
| Subject information and informed consent form (for publication) | L17 C4891024_Main ICD_Phase Ib_BE_NL_Public | 2 |
| Subject information and informed consent form (for publication) | L17 C4891024_Main ICD_Phase Ib_BE_NL_TC | 1 |
| Subject information and informed consent form (for publication) | L18 C4891024_Main ICD_Phase Ib_BE_FR_Public | 2 |
| Subject information and informed consent form (for publication) | L18 C4891024_Main ICD_Phase Ib_BE_FR_TC | 1 |
| Subject information and informed consent form (for publication) | L19 C4891024_Main ICD_Phase II_EN_Public | 2 |
| Subject information and informed consent form (for publication) | L19 C4891024_Main ICD_Phase II_EN_TC | 1 |
| Subject information and informed consent form (for publication) | L1a C4891024_Main Country ICD_ES_Public | 4 |
| Subject information and informed consent form (for publication) | L1a C4891024_MAIN ICD_FR_Public | 3 |
| Subject information and informed consent form (for publication) | L1a C4891024_MAIN ICD_IT_Public | N/A |
| Subject information and informed consent form (for publication) | L2 C4891024_Addendum for Treatment Beyond Progression ICD_BE_FR_Public | 2 |
| Subject information and informed consent form (for publication) | L2 C4891024_Addendum for Treatment Beyond Progression ICD_BE_FR_TC_Public | 2 |
| Subject information and informed consent form (for publication) | L2 C4891024_Addendum for Treatment Beyond Progression_Country level ICD_ES_Public | 2 |
| Subject information and informed consent form (for publication) | L2 C4891024_ICD ADDENDUM BEYOND PROGRESSION_FR_Public | 1 |
| Subject information and informed consent form (for publication) | L2 C4891024_ICD ADDENDUM BEYOND PROGRESSION_IT_Public | 1 |
| Subject information and informed consent form (for publication) | L20 C4891024_Main ICD_Phase II_BE_NL_Public | 2 |
| Subject information and informed consent form (for publication) | L20 C4891024_Main ICD_Phase II_BE_NL_TC | 1 |
| Subject information and informed consent form (for publication) | L21 C4891024_Main ICD_Phase II_BE_FR _Public | 2 |
| Subject information and informed consent form (for publication) | L2a C4891024_Addendum for Treatment Beyond Progression_Country level ICD_ES_TC_Public | 2 |
| Subject information and informed consent form (for publication) | L3 C4891024_Addendum for Treatment Beyond Progression ICD_BE_NL_Public | 2 |
| Subject information and informed consent form (for publication) | L3 C4891024_Addendum for Treatment Beyond Progression ICD_BE_NL_TC_Public | 2 |
| Subject information and informed consent form (for publication) | L3 C4891024_ICD OPTIONAL TUMOR BIOPSY_FR_Public | 1 |
| Subject information and informed consent form (for publication) | L3 C4891024_Optional biopsy_Country Level ICD_ES_Public | 2 |
| Subject information and informed consent form (for publication) | L3a C4891024_ICD OPTIONAL TUMOR BIOPSY_IT_Public | 2 |
| Subject information and informed consent form (for publication) | L3a C4891024_Optional biopsy_Country Level ICD_ES_TC_Public | 2 |
| Subject information and informed consent form (for publication) | L4 C4891024_ICD EOT Biopsy_EN_Public | 2 |
| Subject information and informed consent form (for publication) | L4 C4891024_ICD EOT Biopsy_EN_TC_Public | 2 |
| Subject information and informed consent form (for publication) | L4 C4891024_PPRI ICD_FR_Public | 1-1-0 |
| Subject information and informed consent form (for publication) | L4 C4891024_PPRI ICD_IT_Public | 1 |
| Subject information and informed consent form (for publication) | L4 C4891024_Pregnant Partner Model ICF_ES_Public | 1 |
| Subject information and informed consent form (for publication) | L5 C4891024_ICD EOT Biopsy_BE_FR_Public | 2 |
| Subject information and informed consent form (for publication) | L5 C4891024_ICD EOT Biopsy_BE_FR_TC_Public | 2 |
| Subject information and informed consent form (for publication) | L5 C4891024_Retained Research Samples ICD_ES_Public | 1 |
| Subject information and informed consent form (for publication) | L6 C4891024_ICD EOT Biopsy_BE_NL_Public | 2 |
| Subject information and informed consent form (for publication) | L6 C4891024_ICD EOT Biopsy_BE_NL_TC_Public | 2 |
| Subject information and informed consent form (for publication) | L6a C4891024_Privacy Consent_IT_Public | 2 |
| Subject information and informed consent form (for publication) | L7 C4891024_GP Letter_IT_Public | 1.0 |
| Subject information and informed consent form (for publication) | L7 C4891024_PPRIF_EN_Public | 2 |
| Subject information and informed consent form (for publication) | L7 C4891024_PPRIF_EN_TC_Public | 2 |
| Subject information and informed consent form (for publication) | L8 C4891024_PPRIF_BE_FR_Public | 2 |
| Subject information and informed consent form (for publication) | L8 C4891024_PPRIF_BE_FR_TC_Public | 2 |
| Subject information and informed consent form (for publication) | L9 C4891024_PPRIF_BE_NL_Public | 2 |
| Subject information and informed consent form (for publication) | L9 C4891024_PPRIF_BE-NL_TC_Public | 2 |
| Synopsis of the protocol (for publication) | D2_C4891024_Protocol Synopsis_Public | PA1 |
| Synopsis of the protocol (for publication) | D2_Protocol Synopsis_IT_2023-507125-41-00_C4891024_IT_public | PA2 |
| Synopsis of the protocol (for publication) | D3 Protocol Synopsis_BE_GER_C4891024_public | PA1 |
| Synopsis of the protocol (for publication) | D3_C4891024_Protocol Synopsis_BE-dut_public | PA1 |
| Synopsis of the protocol (for publication) | D3_C4891024_Protocol Synopsis_BE-fre_public | PA1 |
| Synopsis of the protocol (for publication) | D3_C4891024_Protocol Synopsis_FR-fre_public | PA1 |
| Synopsis of the protocol (for publication) | D3_C4891024_Protocol Synopsis_spa_public | PA1 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-31 | Spain | Acceptable with conditions 2024-02-26
|
2024-02-26 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-03-12 | Acceptable with conditions | 2024-04-23 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-03-15 | Spain | Acceptable with conditions | 2024-04-19 |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-08-09 | Acceptable with conditions | 2024-08-29 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-08-14 | Acceptable with conditions | 2024-09-25 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-01-15 | Spain | Acceptable 2025-03-25
|
2025-03-25 |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-08-29 | Acceptable 2025-10-14
|
2025-11-18 | |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-11-28 | Spain | Acceptable 2025-10-14
|
2025-11-28 |