Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
273
Countries
9
Sites
38
RET-Mutant Medullary Thyroid Cancer
To compare PFS of patients with progressive, advanced, kinase inhibitor naïve, RET-mutant MTC treated with selpercatinib versus cabozantinib or vandetanib
Key facts
- Sponsor
- Eli Lilly & Co.
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years, 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 10 Mar 2020 → ongoing
- Decision date (initial)
- 2024-05-16
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-506782-56-00
- EudraCT number
- 2019-001978-28
- WHO UTN
- U1111-1301-5617
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic, Therapy, Safety, Efficacy
To compare PFS of patients with progressive, advanced, kinase inhibitor naïve, RET-mutant MTC treated with selpercatinib versus cabozantinib or vandetanib
Conditions and MedDRA coding
RET-Mutant Medullary Thyroid Cancer
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- Yes
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Participants must have medullary thyroid cancer that is not able to be removed by surgery or has spread to other places in the body, has not been treated with certain medications previously, and has evidence on imaging studies that the cancer has gotten bigger in the previous 14 months
- Participants must have evidence that their cancer is caused by a mutation in the RET gene
- Participants must be in fair to good general health and not have another serious medical condition
- Participants must be willing to use highly effective contraception during the study
Exclusion criteria 2
- Participants must not have cancer that has spread to the brain or spinal cord that is causing symptoms
- Participants must not have a heart condition that puts you at risk for abnormal heart rhythms
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- PFS by BICR
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
SUB193120 · Substance
- Active substance
- Selpercatinib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Drug substance (DS) for clinical trials (CTs) and for commercial use (CU) have been produced utilizing the same sequence of synthetic steps, starting materials, and intermediates. Same manufacturing process and unit formula are utilized for CTs and CU DP. Materials, may be manufactured, packaged, and labeled at different facilities. Commitments relative to materials, specifications, and shelf-life for CT and CU materials may be different but of comparable quality and ensure product safety.
SUB193120 · Substance
- Active substance
- Selpercatinib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Drug substance (DS) for clinical trials (CTs) and for commercial use (CU) have been produced utilizing the same sequence of synthetic steps, starting materials, and intermediates. Same manufacturing process and unit formula are utilized for CTs and CU DP. Materials, may be manufactured, packaged, and labelled at different facilities. Commitments relative to materials, specifications, and shelf-life for CT and CU materials may be different but of comparable quality and ensure product safety.
Comparator 4
SCP266711 · ATC
- Active substance
- Vandetanib
- Route of administration
- ORAL USE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XE12 — VANDETANIB
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Packaging and labelling
PRD11254263 · Product
- Active substance
- Cabozantinib
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/08/610
SCP14977795 · ATC
- Active substance
- Cabozantinib
- Substance synonyms
- XL-184, Cyclopropane-1,1-dicarboxylic acid [4-(6,7-dimethoxy-quinolin-4-yloxy)-phenyl]-amide (4-fluoro-phenyl)-amide, BMS-907351
- Route of administration
- ORAL USE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XE26 — CABOZANTINIB
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/08/610
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Packaging and labelling
PRD11254262 · Product
- Active substance
- Cabozantinib
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/08/610
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 16
| Organisation | City, country | Duties |
|---|---|---|
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Data management |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| Rebar Interactive LLC ORG-100045545
|
Austin, United States | Other |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Laboratory analysis |
| Praxis Communications LLC ORG-100045170
|
Buffalo, United States | Other |
| Signant Health Global LLC ORG-100040604
|
Blue Bell, United States | Data management |
| Modus Outcomes ORL-000004956
|
Cary, NC, United States | Other |
| Colpitts Clinical ORL-000004954
|
Scotland, United Kingdom | Other |
| Life Technologies ORL-000005152
|
Carlsbad, CA,, United States | Laboratory analysis |
| Bioclinica Inc. ORG-100033079
|
Princeton, United States | Other, Laboratory analysis |
| Iqvia Rds Inc. ORG-100043858
|
Durham, United States | On site monitoring, Code 5 |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Data management |
| Pharmaceutical Product Development LLC ORG-100016999
|
Wilmington, United States | Code 10 |
| Brightech International, LLC ORL-000001391
|
Somerset, NJ, United States | Code 10 |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Data management |
| Alturas Analytics Inc. ORG-100045347
|
Moscow, United States | Laboratory analysis |
Locations
9 EU/EEA countries · 38 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 1 | 1 |
| Czechia | Ended | 6 | 1 |
| France | Ongoing, recruitment ended | 36 | 12 |
| Germany | Ongoing, recruitment ended | 11 | 7 |
| Greece | Ended | 4 | 1 |
| Italy | Ongoing, recruitment ended | 19 | 6 |
| Netherlands | Ongoing, recruitment ended | 8 | 4 |
| Poland | Ongoing, recruitment ended | 20 | 2 |
| Spain | Ongoing, recruitment ended | 9 | 4 |
| Rest of world
Korea, Republic of, Russian Federation, Brazil, China, India, Australia, Israel, Taiwan, Japan, Canada
|
— | 159 | — |
Investigational sites
Univerzita Karlova 2 Lekarska Fakulta
Onkologicka klinika 2. LF UK a FN Motol, V Uvalu 84/1, 150 06, Prague 5
Centre Hospitalier Universitaire D'Angers
Oncologie, 4 Rue Larrey, 49100, Angers
Centre Leon Berard
Oncologie, 28 Rue Laennec, 69008, Lyon
Institut Gustave Roussy
Oncologie, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Francois Baclesse
Oncologie, 3 Avenue Du General Harris, Cs 45026, Caen Cedex 5
Centre Paul Strauss
Oncologie, 17 Rue Albert Calmette BP23025, STRASBOURG, STRASBOURG, Alsace
Centre Jean Perrin
Oncologie, 58 Rue Montalembert, 63011, Clermont Ferrand Cedex1
Institut Bergonie
Oncologie, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
Assistance Publique Hôpitaux de Marseille - Hôpital Nord
Oncologie, Chemin de Bourrely, Marseille,, Bouches-du-Rhône
Hôpital Claude Huriez - CHU de Lille
Oncologie, 1 Place de Verdun, Rue Michel Polonowski, Lille
Institut Universitaire Du Cancer Toulouse-Oncopole
Oncologie, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
University Hospitals Pitie Salpetriere Charles Foix
Oncologie, 47 To 83 Boulevard De L Hopital, 75013, Paris
Centr Georges Francois Leclerc
Oncologie, 1 Rue Professeur Marion, 21000, Dijon
Universitaetsklinikum Wuerzburg AöR
Medizinische Klinik Und Poliklinik 1, Oberduerrbacher Strasse 6, Grombuehl, Wuerzburg
Medizinische Hochschule Hannover
Department of Hematology, Hemostasis, Oncology and Stem Cell Transplantation, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
Charite Universitaetsmedizin Berlin KöR
Department of Endocrinology and Metabolism, Chariteplatz 1, Mitte, Berlin
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Endokrinologie und Stoffwechselerkrankungen, Langenbeckstrasse 1, Oberstadt, Mainz
München Campus Großhadern - Medizinische Klinik und Poliklinik IV
Medizinische Klinik und Poliklinik IV, Marchioninistr. 15, 81377, München
Universitaetsklinikum Magdeburg AöR
N/A, Leipziger Strasse 44, 39120, Magdeburg
Universitaetsklinikum Essen
Klinik für Endokrinologie, Diabetologie und Stoffwechsel, Hufelandstrasse 55, Medizinisches Zentrum, Essen
Alexandra Hospital
University Clinic of Therapeutics, Vassilissas Sofias Avenue 80, 115 28, Athens
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Dipartimento di Medicina Traslazionale e di Precisione, Viale Del Policlinico 155, 00161, Rome
Fondazione IRCCS Istituto Nazionale Dei Tumori
SC Oncologia Medica 3 - Tumori Testa-collo, Via Giacomo Venezian 1, 20133, Milan
I.F.O. Istituti Fisioterapici Ospitalieri
Endocrinologia Oncologica, Via Elio Chianesi N 53, 00144, Rome
Istituto Auxologico Italiano
Division of Endocrine and Metabolic Diseases, Via Mercalli 32, 20122, Milano
Azienda Ospedaliera Universitaria Federico II Di Napoli
Public Health, Via Sergio Pansini 5, 80131, Naples
Azienda Ospedaliero Universitaria Pisana
Department of Clinical and Experimental Medicine - Endocrine Unit, Via Paradisa 2, Building 8, Pisa
Universitair Medisch Centrum Groningen
Oncology, Hanzeplein 1, 9713 GZ, Groningen
Netherlands Cancer Institute
Oncology, Plesmanlaan 121, 1066 CX, Amsterdam
University Hospital Maastricht
Oncology, P Debyelaan 25, 6229 HX, Maastricht
Leids Universitair Medisch Centrum (LUMC)
Oncology, Albinusdreef 2, 2333 ZA, Leiden
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
NA, Ul. Wybrzeze Armii Krajowej 15, 44-102, Gliwice
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach
NA, Ul. Prezydenta Stefana Artwinskiego 3, 25-734, Kielce
Hospital Universitario La Paz
Medical Oncology, Paseo Castellana 261, 28046, Madrid
Hospital Universitari Vall D Hebron
Medical Oncology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital General Universitario Gregorio Marañón
Oncology, C/MAIQUEZ 7, 28009, Madrid
Hospital Universitario Ramon Y Cajal
Medical Oncology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2021-02-03 | 2021-08-25 | 2022-08-08 | ||
| Czechia | 2020-06-10 | 2026-02-25 | 2021-12-01 | 2022-12-02 | |
| France | 2020-05-26 | 2020-07-01 | 2023-03-16 | ||
| Germany | 2020-07-16 | 2020-07-16 | 2022-08-23 | ||
| Greece | 2021-02-03 | 2026-04-21 | 2021-03-11 | 2022-12-15 | |
| Italy | 2020-06-08 | 2020-10-05 | 2023-02-15 | ||
| Netherlands | 2021-03-25 | 2021-06-08 | 2022-12-20 | ||
| Poland | 2020-08-14 | 2020-08-28 | 2023-02-15 | ||
| Spain | 2020-03-10 | 2020-05-07 | 2023-02-16 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 173 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_ Protocol 2023-506782-56-00_Redacted | l |
| Protocol (for publication) | D1_Protocol_2023-506782-56-00_GR_Redacted | k |
| Protocol (for publication) | D4_JZJB_Patient Documents Copyright | 1.0 |
| Recruitment arrangements (for publication) | K1_JZJB_Blank document for Recruitment Arrangement_Recruitment closed | 1 |
| Recruitment arrangements (for publication) | K1_JZJB_Blank document for Recruitment Arrangement_Recruitment closed | 1 |
| Recruitment arrangements (for publication) | K1_JZJB_Blank document for Recruitment Arrangement_Recruitment closed | 1.0 |
| Recruitment arrangements (for publication) | K1_JZJB_Blank document for Recruitment Arrangement_Recruitment closed | 1 |
| Recruitment arrangements (for publication) | K1_JZJB_Blank document for Recruitment Arrangement_Recruitment closed | 1.0 |
| Recruitment arrangements (for publication) | K1_JZJB_Blank document for Recruitment Arrangement_Recruitment closed | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_JZJB | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Dear Doctor letter_JZJB | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Flyer_JZJB | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Guide visites_JZJB | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Investigator Letter_JZJB | 1.0 |
| Recruitment arrangements (for publication) | K3_List of planned sites_Belgium_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Addendum Crossover_adult_CZ | 7.0 |
| Subject information and informed consent form (for publication) | L1_ICF Addendum Crossover_child 12-14y_CZ | 6.0 |
| Subject information and informed consent form (for publication) | L1_ICF Addendum Crossover_child 15-17y_CZ | 7.0 |
| Subject information and informed consent form (for publication) | L1_ICF Addendum Crossover_parents_CZ | 7.0 |
| Subject information and informed consent form (for publication) | L1_ICF Addendum Switch child 15-17y_CZ | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Addendum Switch_adult_CZ | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Addendum Switch_child 12-14y_CZ | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Addendum Switch_parents_CZ | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Addendum_Data Privacy_adult_CZ | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF Addendum_Data Privacy_parents_CZ | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF Addendum_Prescreening_adult_CZ | 5.0 |
| Subject information and informed consent form (for publication) | L1_ICF Addendum_Prescreening_child 12-14y_CZ | 5.0 |
| Subject information and informed consent form (for publication) | L1_ICF Addendum_Prescreening_child 15-17y_CZ | 5.0 |
| Subject information and informed consent form (for publication) | L1_ICF Addendum_Prescreening_parents_CZ | 5.0 |
| Subject information and informed consent form (for publication) | L1_ICF Assent Main_child 12-14y_CZ | 10.0 |
| Subject information and informed consent form (for publication) | L1_ICF Assent Main_child 15-17y_CZ_Redacted | 11 |
| Subject information and informed consent form (for publication) | L1_ICF Main adult_CZ_Redacted | 11 |
| Subject information and informed consent form (for publication) | L1_ICF Main parents_CZ_Redacted | 11 |
| Subject information and informed consent form (for publication) | L1_ICF SoC_CZ_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_Crossover_GR_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_Main_GR_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_Prescreening_GR_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_SoC_Main and Crossover_GR_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_SoC_Main and Crossover_GR_Redacted_ | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_SoC1_Main_redacted_PL | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Switch Treatment_Addendum_GR | 1 |
| Subject information and informed consent form (for publication) | L1_Main ICF SoC_clean_CZ_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF _assent_Redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF _crossover assent_Redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF _crossover_Redacted | 11 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF _Redacted | 12 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent Form_BEDU_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent Form_BEFR_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent Form_EN_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Crossover Assent_BEDU_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Crossover Assent_BEFR_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Crossover Assent_EN_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Crossover_BEDU_Redacted | 7.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Crossover_BEFR_Redacted | 7.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Crossover_EN_Redacted | 7.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Global_Addendum | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_BEDU_Redacted | 9.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_BEFR_Redacted | 9.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_EN_Redacted | 9.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_BEDU | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_BEFR | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_EN | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Patient | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Roll-over_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Summary of Changes ICF Main and Crossover_BEDU_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Summary of Changes ICF Main and Crossover_BEFR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Summary of Changes ICF Main and Crossover_ENG_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addenddum 12_2 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum 12.2 | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum Adult_ IT_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum for Exceptional Switch | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum ICF_Switch | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adenda 12_2_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adenda cambio de tratamiento_Adultos_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adenda cambio de tratamiento_Padres_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adenda preseleccion_Adultos_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adenda preseleccion_Asentimiento ninos 12-18 | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adenda preseleccion_Padres_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adult_crossover_JZJB_Redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adult_Main_JZJB_Redacted | 9.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent_12-14yo_crossover_JZJB_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent_12-14yo_Main_JZJB_Redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent_15-17yo_crossover_JZJB_Redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent_15-17yo_Main_JZJB_Redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Colpitts | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Country Reimbursement and Reminder Addendum ICF_Adultos_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Country Reimbursement and Reminder Addendum ICF_Padres_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Crossover Adult_ IT_Redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Crossover_Adultos_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Crossover_Asentimiento ninos 12-18_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Crossover_Padres_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Crossover_Redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ICF Summary of changes_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Legal Rep_crossover_JZJB_Redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Legal Rep_Main_JZJB_Redacted | 9.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Adult_ IT_Redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_mineurs majeurs_cross-over_JZJB_Redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_mineurs majeurs_Main_JZJB_Redacted | 9.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Prescreening Addendum | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Prescreening Assent Addendum | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Principal_Adultos_Redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Principal_Asentimiento ninos 12-18_Redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Principal_Padres_Redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_SoC_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes 1_FRA_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of changes 1_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes 2_FRA_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of changes 2_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes_BEDU_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes_BEDU_Redacted_ | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes_BEFR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes_BEFR_Redacted_ | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes_ENG_Redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes_ITA_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of changes_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Switch Treatment Addendum_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS_Crossover Informed Consent Form_Redacted | 10 |
| Subject information and informed consent form (for publication) | L1_SIS_Main Informed Consent Form_Redacted | 12 |
| Subject information and informed consent form (for publication) | L1_SIS_Prescreening Addendum Informed Consent Form_Redacted | 3 |
| Subject information and informed consent form (for publication) | L2_Gp Letter_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information Insurance Conditions for Patient | N/A |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Consent procedure | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Emergency Card | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study Participant Contact Card | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Thank You Card_BEDU | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Thank You Card_BEFR | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Thank You Card_EN | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Visit Guide_BEDU | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Visit Guide_BEFR | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Visit Guide_EN | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information materials_ApptReminderCard_GR | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information materials_Patient Card_GR | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information materials_ThankYouCard_GR | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information materials_VisitGuide_GR | 3 |
| Subject information and informed consent form (for publication) | L2_Patient Card_ITA | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient Card_JZJB | 1.0 |
| Subject information and informed consent form (for publication) | L2_Thank you card_ITA | 1.0 |
| Subject information and informed consent form (for publication) | L3_Other subject information Contact Card for Study Participants | N/A |
| Subject information and informed consent form (for publication) | L3_Patient Contact Card | 3 |
| Subject information and informed consent form (for publication) | L3_Patient Information Card_CZ | 1.0 |
| Subject information and informed consent form (for publication) | L3_Thank You Card_CZ | 1.0 |
| Subject information and informed consent form (for publication) | L4_Other subject information ApptReminderCard | N/A |
| Subject information and informed consent form (for publication) | L5_Other subject information Fundoscopic ExamVisitGuide | 3 |
| Subject information and informed consent form (for publication) | L6_Other subject information Patient Brochure | N/A |
| Subject information and informed consent form (for publication) | L7_Other subject information Medullary Thyroid Cancer Flyer | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | Blanket Statement - Document not published anymore | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | Blanket Statement - Document not published anymore | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Cabometyx_tracked changes | 2 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_2023-506782-56-00_ENG | k |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_2023-506782-56-00_ENG_Track changes | k |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-506782-56-00_GR | k |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-506782-56-00_GR | i |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-506782-56-00_Track Changes_GR | k |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_CZ_2023-506782-56-00 | k |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_CZ_2023-506782-56-00_tracked | k |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES_2023-506782-56-00 | k |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES_2023-506782-56-00_TC | k |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_FR_2023-506782-56-00 | j |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR_2023-506782-56-00_TC | j |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_NL 2023-506782-56-00 | k |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_NL_TC 2023-506782-56-00 | k |
| Synopsis of the protocol (for publication) | D1_Protocol_Synopsis_2023-506782-56-00_PL | k |
| Synopsis of the protocol (for publication) | D1_Protocol_Synopsis_2023-506782-56-00_PL_TC | k |
| Synopsis of the protocol (for publication) | D1_Protocol_synopsis_BEDU | k |
| Synopsis of the protocol (for publication) | D1_Protocol_synopsis_BEFR | k |
| Synopsis of the protocol (for publication) | D1_Protocol_synopsis_BEGE | k |
| Synopsis of the protocol (for publication) | D1_Protocol_synopsis_DEBE | j |
| Synopsis of the protocol (for publication) | D1_Protocol_synopsis_IT_2023-506782-56-00 | j |
| Synopsis of the protocol (for publication) | D1_Protocol_synopsis_IT_2023-506782-56-00_TC | j |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-28 | Italy | Acceptable 2024-05-15
|
2024-05-16 |
| 2 | SUBSEQUENT ADDITION OF MSC | APP-2 | 2024-07-29 | 2024-10-18 | ||
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-10-17 | Acceptable | 2024-11-25 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-10-29 | Acceptable | 2025-01-23 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-02-06 | Italy | Acceptable 2025-05-19
|
2025-05-20 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-06-19 | Acceptable 2025-05-19
|
2025-06-19 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-07-11 | Acceptable | 2025-09-05 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-11-13 | Italy | Acceptable 2026-03-09
|
2026-03-09 |