Rollover study for continued safety and tolerability in subjects treated with spartalizumab alone or in combination with other study treatments

2023-508841-42-00 Protocol CPDR001X2X01B Human pharmacology (Phase I) - Other Ongoing, recruitment ended

Start 30 Oct 2019 · Status Ongoing, recruitment ended · 8 EU/EEA countries · 28 sites · Protocol CPDR001X2X01B

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Other
Status Ongoing, recruitment ended
Participants planned 119
Countries 8
Sites 28

Different types of advanced cancer

To collect safety and tolerability data for spartalizumab as single agent or in combination with other study treatments

Key facts

Sponsor
Novartis Pharma AG
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Neoplasms [C04]
Trial duration
30 Oct 2019 → ongoing
Decision date (initial)
2024-04-02
Transition trial
Yes
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes
Funding sources
Novartis Pharma AG

External identifiers

EU CT number
2023-508841-42-00
EudraCT number
2019-000508-14
ClinicalTrials.gov
NCT04058756

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Others

To collect safety and tolerability data for spartalizumab as single agent or in combination with other study treatments

Secondary objectives 1

  1. To allow subjects enrolled in a spartalizumab Novartis-sponsored study continued access to study treatment

Conditions and MedDRA coding

Different types of advanced cancer

VersionLevelCodeTermSystem organ class
21.1 LLT 10065252 Solid tumor 10029104
21.0 LLT 10048683 Advanced cancer 10029104
21.1 PT 10028997 Neoplasm malignant 100000004864

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

  1. Signed informed consent must be obtained prior to participation in the study.
  2. Subject is currently enrolled in a pre-defined Novartis-sponsored study and is receiving spartalizumab as single agent or in combination with other study treatment.
  3. Subject is currently deriving clinical benefit from the study treatment, as determined by the investigator.
  4. Subject has demonstrated compliance, as assessed by the investigator, with the parent protocol requirements.
  5. Subject is willing and able to comply with the scheduled visits and treatment plans.

Exclusion criteria 2

  1. Subject has been permanently discontinued from spartalizumab in the parent protocol for any reason other than enrollment in the CPDR001X2X01B study.
  2. Subject does not meet the criteria specified in the parent protocol criteria for continued study treatment.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. The primary endpoint is the frequency and nature of adverse events (AEs) and serious adverse events (SAE), as well as subjects with dose interruptions and dose reductions.

Secondary endpoints 1

  1. Number of subjects receiving spartalizumab as single agent or in combination with other study treatments and duration of exposure

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 20

MCS110

PRD10908857 · Product

Active substance
Lacnotuzumab
Substance synonyms
RECOMBINANT HUMAN MONOCLONAL ANTIBODY OF THE IGG1 KAPPA CLASS AGAINST HUMAN MACROPHAGE COLONY-STIMULATING FACTOR, MCS110
Pharmaceutical form
CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS USE
Max daily dose
7.5 mg/kg milligram(s)/kilogram
Max total dose
1330 mg/kg milligram(s)/kilogram
Max treatment duration
533 Week(s)
Authorisation status
Not Authorised
MA holder
NOVARTIS PHARMA AG
Paediatric formulation
No
Orphan designation
No

DKY709

PRD6728822 · Product

Active substance
3-6-1-BENZYLPIPERIDIN-4-YL-3-OXO-1H-ISOINDOL-2-YLPIPERIDINE-26-DIONE
Substance synonyms
DKY709, NVP-DKY709
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL USE
Max daily dose
00 DF dosage form
Max total dose
00 DF dosage form
Max treatment duration
533 Week(s)
Authorisation status
Not Authorised
MA holder
NOVARTIS PHARMA AG
Paediatric formulation
No
Orphan designation
No

NIR178

PRD4797391 · Product

Active substance
Taminadenant
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL USE
Max daily dose
480 mg milligram(s)
Max total dose
1.79 kg kilogram(s)
Max treatment duration
533 Week(s)
Authorisation status
Not Authorised
MA holder
NOVARTIS PHARMA AG
Paediatric formulation
No
Orphan designation
No

NIR178

PRD5414300 · Product

Active substance
Taminadenant
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL USE
Max daily dose
480 mg milligram(s)
Max total dose
1.79 kg kilogram(s)
Max treatment duration
533 Week(s)
Authorisation status
Not Authorised
MA holder
NOVARTIS PHARMA AG
Paediatric formulation
No
Orphan designation
No

NIR178

PRD5065056 · Product

Active substance
Taminadenant
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL USE
Max daily dose
480 mg milligram(s)
Max total dose
1.79 kg kilogram(s)
Max treatment duration
533 Week(s)
Authorisation status
Not Authorised
MA holder
NOVARTIS PHARMA AG
Paediatric formulation
No
Orphan designation
No

TMT212

PRD10732001 · Product

Active substance
Trametinib Dimethyl Sulfoxide
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
2 mg milligram(s)
Max total dose
7.4 g gram(s)
Max treatment duration
533 Week(s)
Authorisation status
Not Authorised
ATC code
L01EE01 — -
MA holder
NOVARTIS PHARMA AG
Paediatric formulation
No
Orphan designation
Yes
Orphan designation number
EU/3/20/2374

TMT212

PRD10732002 · Product

Active substance
Trametinib Dimethyl Sulfoxide
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
2 mg milligram(s)
Max total dose
7.4 g gram(s)
Max treatment duration
533 Week(s)
Authorisation status
Not Authorised
ATC code
L01EE01 — -
MA holder
NOVARTIS PHARMA AG
Paediatric formulation
No
Orphan designation
Yes
Orphan designation number
EU/3/20/2374

INC280

PRD3004215 · Product

Active substance
Capmatinib
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
600 mg milligram(s)
Max total dose
2.23 kg kilogram(s)
Max treatment duration
533 Week(s)
Authorisation status
Not Authorised
MA holder
NOVARTIS PHARMA SERVICES AG
Paediatric formulation
No
Orphan designation
No

Trametinib Dimethyl Sulfoxide

SUB167251 · Substance

Active substance
Trametinib Dimethyl Sulfoxide
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
2 mg milligram(s)
Max total dose
7.4 g gram(s)
Max treatment duration
533 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
Yes
Orphan designation number
EU/3/20/2374
Modified vs. Marketing Authorisation
Yes
Modification description
Differences to commercial product are: - Packaging sites - Bottle fill-count - Storage conditions - Shelf-life - Labelling

Trametinib Dimethyl Sulfoxide

SUB167251 · Substance

Active substance
Trametinib Dimethyl Sulfoxide
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
2 mg milligram(s)
Max total dose
7.4 g gram(s)
Max treatment duration
533 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
Yes
Orphan designation number
EU/3/20/2374
Modified vs. Marketing Authorisation
Yes
Modification description
Differences to commercial product are: - Packaging sites - Bottle fill-count - Storage conditions - Shelf-life - Labelling

NIZ985

PRD7878601 · Product

Active substance
Heterodimeric INTERLEUKIN-15
Pharmaceutical form
CONCENTRATE FOR SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS USE
Max daily dose
12 µg/Kg microgram(s)/kilogram
Max total dose
4.7 mg/kg milligram(s)/kilogram
Max treatment duration
533 Week(s)
Authorisation status
Not Authorised
MA holder
NOVARTIS PHARMA SERVICES AG
Paediatric formulation
No
Orphan designation
No

Canakinumab

SUB30137 · Substance

Active substance
Canakinumab
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS USE
Max daily dose
600 mg milligram(s)
Max total dose
39.6 g gram(s)
Max treatment duration
533 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
Secondary repackaging, relabeling

LAG525

PRD10908856 · Product

Active substance
Ieramilimab
Pharmaceutical form
CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS USE
Max daily dose
800 mg milligram(s)
Max total dose
106.4 g gram(s)
Max treatment duration
533 Week(s)
Authorisation status
Not Authorised
MA holder
NOVARTIS PHARMA AG
Paediatric formulation
No
Orphan designation
No

LXH254

PRD10916782 · Product

Active substance
Naporafenib
Substance synonyms
LXH254, LXH-254, N-{3-[2-(2-HYDROXYETHOXY)-6-(MORPHOLIN-4-YL)PYRIDIN-4-YL]-4-METHYLPHENYL}-2-(TRIFLUOROMETHYL)PYRIDINE-4-CARBOXAMIDE
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
800 mg milligram(s)
Max total dose
2.98 kg kilogram(s)
Max treatment duration
533 Week(s)
Authorisation status
Not Authorised
MA holder
NOVARTIS PHARMA AG
Paediatric formulation
No
Orphan designation
No

LXH254

PRD4473582 · Product

Active substance
Naporafenib
Pharmaceutical form
TABLET
Route of administration
ORAL USE
Max daily dose
800 mg milligram(s)
Max total dose
2.98 kg kilogram(s)
Max treatment duration
533 Week(s)
Authorisation status
Not Authorised
MA holder
NOVARTIS PHARMA AG
Paediatric formulation
No
Orphan designation
No

LXH254

PRD4473583 · Product

Active substance
Naporafenib
Pharmaceutical form
TABLET
Route of administration
ORAL USE
Max daily dose
800 mg milligram(s)
Max total dose
2.98 kg kilogram(s)
Max treatment duration
533 Week(s)
Authorisation status
Not Authorised
MA holder
NOVARTIS PHARMA AG
Paediatric formulation
No
Orphan designation
No

PDR001

PRD6759834 · Product

Active substance
Spartalizumab
Pharmaceutical form
CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS USE
Max daily dose
400 mg milligram(s)
Max total dose
53.2 g gram(s)
Max treatment duration
533 Week(s)
Authorisation status
Not Authorised
MA holder
NOVARTIS PHARMA AG
Paediatric formulation
No
Orphan designation
No

Dabrafenib Mesylate

SUB128623 · Substance

Active substance
Dabrafenib Mesylate
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL USE
Max daily dose
300 mg milligram(s)
Max total dose
1.12 kg kilogram(s)
Max treatment duration
533 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
Yes
Orphan designation number
EU/3/20/2372
Modified vs. Marketing Authorisation
Yes
Modification description
Clinical and commercial formulations differ in: - Bottle size and fill count - Shelf life - QC and packaging sites - Labels

Dabrafenib Mesylate

SUB128623 · Substance

Active substance
Dabrafenib Mesylate
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL USE
Max daily dose
300 mg milligram(s)
Max total dose
1.12 kg kilogram(s)
Max treatment duration
533 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
Yes
Orphan designation number
EU/3/20/2372
Modified vs. Marketing Authorisation
Yes
Modification description
Clinical and commercial formulations differ in: - Bottle size and fill count - Shelf life - QC and packaging sites - Labels

PDR001

PRD4686040 · Product

Active substance
Spartalizumab
Pharmaceutical form
POWDER FOR SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS USE
Max daily dose
400 mg milligram(s)
Max total dose
53.2 g gram(s)
Max treatment duration
533 Week(s)
Authorisation status
Not Authorised
MA holder
NOVARTIS PHARMA AG
Paediatric formulation
No
Orphan designation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Novartis Pharma AG

220 Total trials 69 Recruiting 130 Ended
Commercial
Sponsor organisation
Novartis Pharma AG
Address
Lichtstrasse 35
City
Basel
Postcode
4056
Country
Switzerland

Scientific contact point

Organisation
Novartis Pharma AG
Contact name
Novartis Pharma Arzneimittel GmbH

Public contact point

Organisation
Novartis Pharma AG
Contact name
Novartis Pharma Arzneimittel GmbH

Third parties 14

OrganisationCity, countryDuties
Parexel International (IRL) Limited
ORG-100022780
 Dublin 2, Ireland Code 12
Icon Clinical Research Limited
ORG-100008322
 Dublin 18, Ireland On site monitoring
Rps Research Iberica S.L.
ORG-100030199
 Barcelona, Spain On site monitoring
Eco-Abc Sp. z o. o.
ORG-100046253
 Belchatow, Poland Other
Opis S.r.l.
ORG-100011127
 Desio, Italy Other
Phardis S.r.l.
ORG-100019559
 Calvenzano, Italy Other
Syneos Health Clinical Spain S.L.
ORG-100009277
 Madrid, Spain On site monitoring
Statmed Sp. z o.o.
ORG-100047187
 Golkow, Poland Other
Mipharm S.p.A.
ORG-100000724
 Milan, Italy Other
Opt-X-Pense Kft.
ORG-100047138
 Budaors, Hungary Other
Movianto Ceska republika s.r.o.
ORG-100012787
 Podoli, Czechia Code 14
Creapharm Clinical Supplies
ORG-100020131
 Reims, France Other
ADR Logistics Kft.
ORG-100045267
 Budaors, Hungary Code 14, Other
IQVIA RDS Spain S.L.
ORG-100014508
 Madrid, Spain On site monitoring

Locations

8 EU/EEA countries · 28 investigational sites

By country

CountryMS statusPlanned subjectsSites
Belgium Ongoing, recruitment ended 7 2
Czechia Ongoing, recruitment ended 2 1
France Ongoing, recruitment ended 8 5
Germany Ongoing, recruitment ended 6 4
Hungary Ongoing, recruitment ended 3 3
Italy Ongoing, recruitment ended 26 7
Poland Ongoing, recruitment ended 1 1
Spain Ongoing, recruitment ended 22 5
Rest of world
Thailand, Singapore, Canada, Hong Kong, Switzerland, Korea, Republic of, United States, Taiwan, China
 — 44 —

Investigational sites

Belgium

2 sites · Ongoing, recruitment ended
UZ Leuven
6001: Medical Oncology, Herestraat 49, 3000, Leuven
Centre hospitalier universitaire de Liege
6002: Medical Oncology, Avenue De L'hopital 1, 4000, Liege

Czechia

1 site · Ongoing, recruitment ended
Masarykuv Onkologicky Ustav
6302: Masarykuv Onkologicky Ustav, Zluty Kopec 543/7, Stare Brno, Brno-Stred

France

5 sites · Ongoing, recruitment ended
Hopital Huriez
7006: Medical Oncology, 1 Place De Verdun, 59045, Lille Cedex
Institut Paoli-Calmettes
7002: Medical Oncology, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Centre Leon Berard
7004: Medical Oncology, 28 Rue Laennec, 69008, Lyon
Institut Gustave Roussy
7001: Medical Oncology, 114 Rue Edouard Vaillant, 94800, Villejuif
Assistance Publique Hopitaux De Marseille
7007: Medical Oncology, 264 Rue Saint Pierre, 13005, Marseille

Germany

4 sites · Ongoing, recruitment ended
Universitaetsklinikum Essen AöR
7511: Klinik fuer Endokrinologie und Stoffwechselerkrankungen, Hufelandstrasse 55, Holsterhausen, Essen
Universitaetsklinikum Ulm AöR
7512: Klinik fuer Innere Medizin III, Albert-Einstein-Allee 29, Eselsberg, Ulm
Universitaetsklinikum Jena KöR
7510: Klinik fuer Innere Medizin II, Am Klinikum 1, Lobeda, Jena
Universitaetsklinikum Heidelberg AöR
7514: National center for Tumor Diseases, Im Neuenheimer Feld 410, Neuenheim, Heidelberg

Hungary

3 sites · Ongoing, recruitment ended
Orszagos Onkologiai Intezet
8303: Dermatoonkologiai Osztaly, Rath Gyorgy Utca 7-9, Kerulet, Budapest XII
University Of Debrecen
8302: Borgyogyaszati Klinika, Nagyerdei Korut 98, 4032, Debrecen
University Of Debrecen
8301: Onkologiai Klinika, Nagyerdei Korut 98, 4032, Debrecen

Italy

7 sites · Ongoing, recruitment ended
Centro Di Riferimento Oncologico Di Aviano
#8006: S.C. Oncologia Medica A, Via Franco Gallini 2, 33081, Aviano
Fondazione IRCCS Istituto Nazionale Dei Tumori
#8001: S.C. Oncologia Medica 1, Via Giacomo Venezian 1, 20133, Milan
Azienda Ospedaliera Universitaria Senese
#8009: U.O.C. Immunoterapia Oncologica, Viale Mario Bracci 2, 53100, Siena
Universita' Degli Studi Di Modena E Reggio Emilia
#8010: S.S. Day Hospital Oncologico, Via Del Pozzo 71, 41124, Modena
Ospedale San Raffaele S.r.l.
#8002: U.O. Oncologia Medica, Via Olgettina 60, 20132, Milan
IRCCS Istituto Nazionale Tumori Fondazione Pascale
#8007: U.O.C. Melanoma, Immunoterapia Oncologica e Terapie Innovative, Via Mariano Semmola 52, 80131, Naples
European Institute Of Oncology S.r.l.
#8008: Divisione Sviluppo Nuovi Farmaci per Terapie Innovative – Oncologia Medica, Via Giuseppe Ripamonti 435, 20141, Milan

Poland

1 site · Ongoing, recruitment ended
Med Polonia Sp. z o.o.
8503, Obornicka 262, 60-693, Poznan

Spain

5 sites · Ongoing, recruitment ended
Institut Catala D'oncologia
#9007: Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital General Universitario Gregorio Maranon
#9002: Oncology, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Clinico Universitario De Valencia
#9005: Oncology, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Clinic De Barcelona
#9006: Oncology, Calle Villarroel 170, 08036, Barcelona
Hospital Universitari Vall D Hebron
#9001: Oncology, 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 startTrial end Recruitment startRecruitment end Early termination
Belgium 2019-11-28 2019-11-28 2024-05-06
Czechia 2022-05-17 2022-05-17 2024-05-06
France 2020-01-29 2020-01-29 2024-05-06
Germany 2020-05-13 2020-05-13 2024-05-06
Hungary 2020-07-21 2020-07-21 2024-05-06
Italy 2019-11-11 2019-11-11 2024-05-06
Poland 2020-07-02 2020-07-02 2024-05-06
Spain 2019-10-30 2019-10-30 2024-05-06

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 75 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Protocol - Signature Page_2023-508841-42-00_1_English_Red 07
Protocol (for publication) D1_Protocol_2023-508841-42-00_1_English_Red 07
Protocol (for publication) EU CTR_Replacement_document no longer subject to publication 01
Recruitment arrangements (for publication) K1_6001_Recruitments Arrangements_1_Dutch_Red 1.0
Recruitment arrangements (for publication) K1_6002_Recruitment Arrangements_1_English_NonRed 1.0
Recruitment arrangements (for publication) K1_Recruitment Arrangements - Country_1_DE_English_NonRed v01
Recruitment arrangements (for publication) K1_Recruitment Arrangements - Country_1_HU_English_NonRed v1.0
Recruitment arrangements (for publication) K1_Recruitment Arrangements - Country_1_IT_English_NonRed 1.0
Recruitment arrangements (for publication) K1_Recruitment Arrangements -Country_1_ES_Spanish_NonRed 03/Jun/19
Recruitment arrangements (for publication) Recruitment Arrangements - Country_1_PL_English_NonRed_T 01
Subject information and informed consent form (for publication) ICF - Follow up for pregnant participant_1_ES_Spanish_NonRed 03/04/2020
Subject information and informed consent form (for publication) ICF - Follow up for pregnant participant_1_HU_Hungarian_NonRed v02.01.00
Subject information and informed consent form (for publication) ICF - Follow up for pregnant partner of participant_1_ES_Spanish_NonRed 03/04/2020
Subject information and informed consent form (for publication) ICF - Follow up for pregnant partner of participant_1_HU_Hungarian_NonRed v02.01.00
Subject information and informed consent form (for publication) ICF - Info Sheet Female Partner_1_ES_Spanish_NonRed v06.05.02
Subject information and informed consent form (for publication) ICF - Info Sheet Female Partner_1_HU_Hungarian_NonRed v06.05.00
Subject information and informed consent form (for publication) ICF - Info Sheet Female Partner_1_IT_Italian_NonRed v06.05.03
Subject information and informed consent form (for publication) ICF - Main ICF - Adult_1_ES_Spanish_NonRed v04.01.01
Subject information and informed consent form (for publication) ICF - Main ICF - Adult_1_IT_Italian_Red v03.02.01
Subject information and informed consent form (for publication) ICF - Main ICF - Adult_10_IT_Italian_NonRed v02.00
Subject information and informed consent form (for publication) ICF - Main ICF - Adult_2_DE_German_NonRed v04.00.00
Subject information and informed consent form (for publication) ICF - Main ICF - Adult_2_HU_Hungarian_NonRed v00.03.03
Subject information and informed consent form (for publication) ICF - Main ICF - Adult_4_DE_German_NonRed v00.03.00
Subject information and informed consent form (for publication) ICF - Main ICF - Adult_4_IT_Italian_Red v03.02.02
Subject information and informed consent form (for publication) ICF - Main ICF - Adult_5_DE_German_NonRed v00.03.00
Subject information and informed consent form (for publication) ICF - Main ICF - Adult_5_ES_Spanish_NonRed v00.03.00
Subject information and informed consent form (for publication) ICF - Main ICF - Adult_6_DE_German_NonRed v02.02.00
Subject information and informed consent form (for publication) ICF - Main ICF - Adult_6_ES_Spanish_NonRed v00-04.00
Subject information and informed consent form (for publication) ICF - Main ICF - Adult_7_ES_Spanish_NonRed v02.02.00
Subject information and informed consent form (for publication) ICF - Main ICF - Adult_9_IT_Italian_NonRed v02.00
Subject information and informed consent form (for publication) ICF - Main ICF Exceptional Release - OOS product_1_ES_Spanish_NonRed v04.00.01
Subject information and informed consent form (for publication) ICF - Optional treatment beyond disease progression_1_PL_Polish_NonRed 1
Subject information and informed consent form (for publication) ICF - Separate Data Protection Consent_1_PL_Polish_NonRed 1
Subject information and informed consent form (for publication) L1_ICF - Follow up for pregnant participant_1_DE_German_NonRed 00.00.00
Subject information and informed consent form (for publication) L1_ICF - Follow up for pregnant participant_1_IT_Italian_NonRed 07.01.03
Subject information and informed consent form (for publication) L1_ICF - Follow up for pregnant partner of participant_1_IT_Italian_NonRed 07.01.03
Subject information and informed consent form (for publication) L1_ICF - Info Sheet Female Partner_1_DE_German_NonRed 06.05.02
Subject information and informed consent form (for publication) L1_ICF - Info Sheet Female Partner_1_Dutch_NonRed v05.04.01
Subject information and informed consent form (for publication) L1_ICF - Info Sheet Female Partner_1_English_NonRed v05.04.01
Subject information and informed consent form (for publication) L1_ICF - Info Sheet Female Partner_1_French_NonRed v05.04.01
Subject information and informed consent form (for publication) L1_ICF - Main ICF - Adult_1_Dutch_NonRed 00.04.05
Subject information and informed consent form (for publication) L1_ICF - Main ICF - Adult_1_English_NonRed 00.04.05
Subject information and informed consent form (for publication) L1_ICF - Main ICF - Adult_1_French_NonRed 00.04.05
Subject information and informed consent form (for publication) L1_ICF - Main ICF - Adult_1_HU_Hungarian_Red v00.03.04
Subject information and informed consent form (for publication) L1_ICF - Main ICF - Adult_1_PL_Polish_NonRed v.5
Subject information and informed consent form (for publication) L1_ICF - Main ICF - Adult_2_ES_Spanish_Red v03.04.03
Subject information and informed consent form (for publication) L1_ICF - Main ICF - Adult_2_IT_Italian_Red 07.01.02
Subject information and informed consent form (for publication) L1_ICF - Main ICF - Adult_3_DE_German_NonRed 00.03.03
Subject information and informed consent form (for publication) L1_ICF - Main ICF - Adult_3_ES_Spanish_Red v06.03.04
Subject information and informed consent form (for publication) L1_ICF - Main ICF - Adult_3_HU_Hungarian_Red v06.03.07
Subject information and informed consent form (for publication) L1_ICF - Main ICF - Adult_3_IT_Italian_Red 07.03.03
Subject information and informed consent form (for publication) L1_ICF - Main ICF - Adult_4_ES_Spanish_Red v06.00.01
Subject information and informed consent form (for publication) L1_ICF - Main ICF - Adult_5_IT_Italian_NonRed 07.03.01
Subject information and informed consent form (for publication) L1_ICF - Main ICF - Adult_6_IT_Italian_Red 07.03.01
Subject information and informed consent form (for publication) L1_ICF - Main ICF - Adult_7_DE_German_NonRed 00.03.01
Subject information and informed consent form (for publication) L1_ICF - Main ICF - Adult_7_IT_Italian_Red 07.04.01
Subject information and informed consent form (for publication) L1_ICF - Main ICF - Adult_8_IT_Italian_Red 07.03.02
Subject information and informed consent form (for publication) L1_ICF - Main ICF Exceptional Release - OOS product_1_Dutch_NonRed 00.04.05
Subject information and informed consent form (for publication) L1_ICF - Main ICF Exceptional Release - OOS product_1_English_NonRed 00.04.05
Subject information and informed consent form (for publication) L1_ICF - Main ICF Exceptional Release - OOS product_1_French_NonRed 00.04.05
Subject information and informed consent form (for publication) L1_ICF - Separate Data Protection Consent_1_ES_Spanish_NonRed v03
Subject information and informed consent form (for publication) L1_ICF - Separate Data Protection Consent_2_ES_Spanish_NonRed v03
Subject information and informed consent form (for publication) L1_List of submitted documents_1_HU_NonRed 18Oct2024
Subject information and informed consent form (for publication) L1_Subject Info Sheet or Other Info_1_IT_Italian_NonRed 07.03.01
Subject information and informed consent form (for publication) L2_ICF Procedure_1_DE_English_NonRed v01
Summary of Product Characteristics (SmPC) (for publication) EU CTR_Replacement_document no longer subject to publication 01
Synopsis of the protocol (for publication) D1_Protocol Summary in Lay Language_1_Czech_NonRed 00
Synopsis of the protocol (for publication) D1_Protocol Summary in Lay Language_1_Dutch_NonRed 00
Synopsis of the protocol (for publication) D1_Protocol Summary in Lay Language_1_English_NonRed 00
Synopsis of the protocol (for publication) D1_Protocol Summary in Lay Language_1_French_NonRed 00
Synopsis of the protocol (for publication) D1_Protocol Summary in Lay Language_1_German_NonRed 00
Synopsis of the protocol (for publication) D1_Protocol Summary in Lay Language_1_Hungarian_NonRed 00
Synopsis of the protocol (for publication) D1_Protocol Summary in Lay Language_1_Italian_NonRed 00
Synopsis of the protocol (for publication) D1_Protocol Summary in Lay Language_1_Polish_NonRed 01
Synopsis of the protocol (for publication) D1_Protocol Summary in Lay Language_1_Spanish_NonRed 00

Application history

8 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-02-14 Germany Acceptable
2024-03-22
 2024-03-22
2 SUBSTANTIAL MODIFICATION SM-1 2024-05-09 Germany Acceptable
2024-08-19
 2024-08-19
3 NON SUBSTANTIAL MODIFICATION NSM-1 2024-10-02 Acceptable
2024-08-19
 2024-10-02
4 SUBSTANTIAL MODIFICATION SM-2 2024-11-01 Germany Acceptable
2025-02-24
 2025-02-24
5 SUBSTANTIAL MODIFICATION SM-3 2025-03-21 Germany Acceptable
2025-06-30
 2025-06-30
6 NON SUBSTANTIAL MODIFICATION NSM-2 2025-08-26 Germany Acceptable
2025-06-30
 2025-08-26
7 SUBSTANTIAL MODIFICATION SM-4 2025-09-04 Acceptable 2025-10-28
8 SUBSTANTIAL MODIFICATION SM-5 2026-01-16 Germany Acceptable
2026-04-13
 2026-04-14

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