Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruitment ended
Participants planned
906
Countries
8
Sites
37
Solid tumors
To evaluate the efficacy of study treatment in patients with alteration/biomarker-positive advanced or metastatic solid tumors (for tumor types that are assessed by RECIST v1.1) based on IRC-assessed ORR
Key facts
- Sponsor
- F. Hoffmann-La Roche AG
- 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
- 15 Mar 2021 → ongoing
- Decision date (initial)
- 2024-07-16
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- F. Hoffmann-La Roche AG
External identifiers
- EU CT number
- 2023-507418-28-00
- EudraCT number
- 2020-001847-16
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Others, Pharmacokinetic, Efficacy
To evaluate the efficacy of study treatment in patients with alteration/biomarker-positive advanced or metastatic solid tumors (for tumor types that are assessed by RECIST v1.1) based on IRC-assessed ORR
Secondary objectives 4
- To evaluate efficacy of study treatment in patients with alteration/biomarker-positive advanced or metastatic solid tumors, alteration/biomarker-positive primary CNS tumors at baseline and alteration/biomarker-positive advanced or metastatic neuroblastoma
- To evaluate the efficacy of study treatment in subgroup of patients with advanced or metastatic solid tumors that are alteration/biomarker-positive solid tumors with CNS metastases at baseline
- To evaluate the impact of study treatment on patient-reported outcome (PROs) of function and symptoms in patients with alteration/biomarker-positive advanced or metastatic solid tumors
- To evaluate the safety and tolerability of study treatment in patients with alteration/biomarker-positive solid tumors
Conditions and MedDRA coding
Solid tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065252 | Solid tumor | 10029104 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Histologically or cytologically confirmed diagnosis of advanced and unresectable or metastatic solid malignancy
- Measurable disease as defined by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1), Response Assessment in Neuro-Oncology (RANO) criteria, or International Neuroblastoma Response Criteria (INRC)
- Performance status as follows: Participants aged ≥ 18 years: Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2; Participants aged 16 to < 18 years: Karnofsky score ≥ 50%; Participants aged < 16 years: Lansky score ≥ 50%
- For participants aged ≥ 18 and <18 years: adequate hematologic and end-organ function
- Disease progression on prior treatment, or previously untreated disease with no available acceptable treatment
- Adequate recovery from most recent systemic or local treatment for cancer
Exclusion criteria 6
- Current participation or enrollment in another therapeutic clinical trial
- Any anticancer treatment within 2 weeks prior to start of study treatment (Please refer to the cohort-specific eligibility criteria for requirements on enrollment, if applicable)
- Whole brain radiotherapy within 14 days prior to start of study treatment
- Stereotactic radiosurgery within 7 days prior to start of study treatment
- Pregnant or breastfeeding, or intending to become pregnant during the study
- History of or concurrent serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe participation in and completion of the study or confounds the ability to interpret data from the study
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 1 Independent Review Committee (IRC)-assessed objective response rate (ORR) based on confirmed (≥4 weeks after initial documentation of response) objective response (per RECIST v1.1)
Secondary endpoints 14
- 1 IRC-assessed duration of response (DOR), clinical benefit rate (CBR), and progression-free survival (PFS) per RECIST v1.1
- 2 Investigator (INV)-assessed ORR, DOR, CBR, and PFS per RECIST v1.1
- 3 IRC- and INV-assessed time to CNS progression per RECIST v1.1
- 4 Overall survival (OS)
- 5 Cohorts A, B, C, D, I, J, and K: IRC-assessed CNS-ORR, CNS-DOR, CNS-CBR, and CNS-PFS per RANO
- 6 Cohorts A, B, C, D, I, J, and K: INV-assessed CNS-ORR, CNS-DOR, CNS-CBR, and CNS-PFS per RANO
- 7 Cohorts A, B, C, D, E, H, I, J, K, L, M, and N: IRC-assessed ORR, DOR, CBR, and PFS per International Neuroblastoma Response Criteria (INRC)
- 8 Cohorts A, B, C, D, E, H, I, J, K, L, M, and N: INV-assessed ORR, DOR, CBR, and PFS per INRC
- 9 Cohorts A, B, C, D, I, J, and K: IRC-assessed IC-ORR, IC-DOR, IC-CBR, IC-PFS rate per RECIST v1.1
- 10. Cohorts A, B, C, D, I, J, and K: INV-assessed IC-ORR, IC-DOR, IC-CBR, IC-PFS per RECIST v1.1
- 11. Descriptive endpoint of time to confirmed deterioration, change from baseline, proportion of patients with a clinical meaningful change on the Global Health Status, Physical Functioning, and Role Functioning scores from the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30
- 12. Descriptive endpoint of time to confirmed symptom onset or worsening from tumor-related symptom scores from the EORTC QLQ-C30 and EORTC IL71
- 13. Incidence, type, and severity of adverse events (based on the NCI CTCAE v5.0), including serious adverse events
- 14. Cohort K: for pediatric patients - evaluate the acceptability and palatability of pralsetinib with Acceptability Survey scores on Day 1 of Cycle 1
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 16
Tecentriq 1 200 mg concentrate for solution for infusion
PRD5434939 · Product
- Active substance
- Atezolizumab
- Substance synonyms
- RO5541267
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Max daily dose
- 1200 mg milligram(s)
- Max total dose
- 166.8 g gram(s)
- Max treatment duration
- 96 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FF05 — -
- Marketing authorisation
- EU/1/17/1220/001
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for clinical trial use.
PRD10948864 · Product
- Active substance
- Camonsertib
- Substance synonyms
- (1R,3r,5S)-3-(6-((R)-3-methylmorpholino)-1-(1H-pyrazol-3-yl)-1H-pyrazolo[3,,4-b]pyridin-4-yl)-8-oxabicyclo[3.2.1]octan-3-ol, RP-3500
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 0 DF dosage form
- Max total dose
- 0 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
PRD11008928 · Product
- Active substance
- Entrectinib
- Pharmaceutical form
- COATED GRANULES
- Route of administration
- ORAL
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 1752 g gram(s)
- Max treatment duration
- 96 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
Rozlytrek 200 mg hard capsules
PRD8236731 · Product
- Active substance
- Entrectinib
- Substance synonyms
- NMS-1191372, N-[5-(3,5-DIFLUOROBENZYL)-1H-INDAZOL-3-YL]-4-(4 METHYLPIPERAZIN-1-YL)-2-(TETRAHYDRO-2H-PYRAN-4-YLAMINO)BENZAMIDE
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 1752 g gram(s)
- Max treatment duration
- 96 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EX14 — -
- Marketing authorisation
- EU/1/20/1460/002
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for clinical trial use.
Rozlytrek 100 mg hard capsules
PRD8236780 · Product
- Active substance
- Entrectinib
- Substance synonyms
- NMS-1191372, N-[5-(3,5-DIFLUOROBENZYL)-1H-INDAZOL-3-YL]-4-(4 METHYLPIPERAZIN-1-YL)-2-(TETRAHYDRO-2H-PYRAN-4-YLAMINO)BENZAMIDE
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 1752 g gram(s)
- Max treatment duration
- 96 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EX14 — -
- Marketing authorisation
- EU/1/20/1460/001
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for clinical trial use.
PRD11081693 · Product
- Active substance
- Divarasib
- Other product name
- GDC-6036
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 0 DF dosage form
- Max total dose
- 0 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- GENENTECH, INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD11081695 · Product
- Active substance
- Divarasib
- Other product name
- GDC-6036
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 0 DF dosage form
- Max total dose
- 0 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- GENENTECH, INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD4815708 · Product
- Active substance
- Alectinib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 1200 mg milligram(s)
- Max total dose
- 3504 g gram(s)
- Max treatment duration
- 96 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01ED03 — -
- Marketing authorisation
- EU/1/16/1169/001
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for clinical trial use.
PRD10776900 · Product
- Active substance
- Belvarafenib
- Substance synonyms
- 4-AMINO-N-(1-((3-CHLORO-2-FLUOROPHENYL)AMINO)-6-METHYLISOQUINOLIN-5-YL)THIENO(3,2-D)PYRIMIDINE-7-CARBOXAMIDE
- Other product name
- BELVARAFENIB, HM95573, GDC-5573, RG6185
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 800 mg milligram(s)
- Max total dose
- 2336 g gram(s)
- Max treatment duration
- 96 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- GENENTECH, INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD9793130 · Product
- Active substance
- Inavolisib
- Other product name
- GDC-0077
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 9 mg milligram(s)
- Max total dose
- 26.28 g gram(s)
- Max treatment duration
- 96 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
PRD9793811 · Product
- Active substance
- Inavolisib
- Other product name
- GDC-0077
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 9 mg milligram(s)
- Max total dose
- 26.28 g gram(s)
- Max treatment duration
- 96 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
PRD9793809 · Product
- Active substance
- Inavolisib
- Other product name
- GDC-0077
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 9 mg milligram(s)
- Max total dose
- 26.28 g gram(s)
- Max treatment duration
- 96 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
PRD9793132 · Product
- Active substance
- Inavolisib
- Other product name
- GDC-0077
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 9 mg milligram(s)
- Max total dose
- 26.28 g gram(s)
- Max treatment duration
- 96 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
PRD9235050 · Product
- Active substance
- Pralsetinib
- Other product name
- BLU-667, BLU123244, BLU3244, X581238, C683, SEE, 72C683
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 1168 g gram(s)
- Max treatment duration
- 96 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
PRD9859714 · Product
- Active substance
- Ipatasertib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 1168 g gram(s)
- Max treatment duration
- 96 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
PRD9859715 · Product
- Active substance
- Ipatasertib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 1168 g gram(s)
- Max treatment duration
- 96 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
F. Hoffmann-La Roche AG
- Sponsor organisation
- F. Hoffmann-La Roche AG
- Address
- Grenzacherstrasse 124
- City
- Basel
- Postcode
- 4058
- Country
- Switzerland
Scientific contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Trial Information System - TISL
Public contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Trial Information System - TISL
Third parties 13
| Organisation | City, country | Duties |
|---|---|---|
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | On site monitoring |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Laboratory analysis |
| Labcorp Early Development Laboratories Inc. ORG-100012865
|
Madison, United States | Laboratory analysis |
| Signant Health Global LLC ORG-100040604
|
Blue Bell, United States | Interactive response technologies (IRT) |
| Median Technologies ORG-100041462
|
Valbonne, France | Laboratory analysis |
| Caris Mpi Inc. ORG-100045200
|
Phoenix, United States | Other |
| Icon Development Solutions LLC ORG-100012400
|
Whitesboro, United States | Laboratory analysis |
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Laboratory analysis |
| Foundation Medicine Inc. ORG-100040457
|
Boston, United States | Laboratory analysis |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| Foundation Medicine GmbH ORG-100040499
|
Penzberg, Germany | Laboratory analysis |
| Ventana Medical Systems Inc. ORG-100043193
|
Oro Valley, United States | Laboratory analysis |
| CellCarta ORG-100039881
|
Antwerp, Belgium | Laboratory analysis |
Locations
8 EU/EEA countries · 37 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 50 | 5 |
| Denmark | Ongoing, recruitment ended | 8 | 1 |
| France | Ongoing, recruitment ended | 74 | 6 |
| Germany | Ongoing, recruitment ended | 7 | 2 |
| Italy | Ongoing, recruitment ended | 100 | 7 |
| Poland | Ongoing, recruitment ended | 60 | 4 |
| Portugal | Ongoing, recruitment ended | 13 | 1 |
| Spain | Ongoing, recruitment ended | 95 | 11 |
| Rest of world
Canada, Japan, Singapore, Australia, United Kingdom, Hong Kong, Brazil, United States, New Zealand, Switzerland, Israel, South Africa, China, Korea, Republic of, Taiwan
|
— | 499 | — |
Investigational sites
Antwerp University Hospital
Multidisciplinary Oncology Centre, Drie Eikenstraat 655, 2650, Edegem
Uz Gent
Pediatric Hematology - Oncology, Corneel Heymanslaan 10, 9000, Gent
Cliniques Universitaires Saint-Luc
Medical oncology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
UZ Leuven
Oncology, Herestraat 49, 3000, Leuven
Grand Hôpital de Charleroi - Site Les Viviers
Oncology & Hematology, Rue du Campus des Viviers 1, 6060, CHARLEROI
Rigshospitalet
Onkologisk Klinik, Blegdamsvej 9, 2100, Copenhagen Oe
Institut Universitaire Du Cancer Toulouse-Oncopole
Medical Oncology, 1 Avenue Irene Joliot Curie, 31100, Toulouse
Institut Bergonie
Medical Oncology, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
Institut Gustave Roussy
Drug Development Department (DITEP) – U981 INSERM, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Leon Berard
Pediatric oncology, 28 Rue Laennec, 69008, Lyon
Centre Hospitalier Regional De Marseille
Pediatric Immunology, Hematology and Oncology Department, 144 Rue Saint Pierre, 13005, Marseille
Centre Oscar Lambret
Oncology, 3 Rue Frederic Combemale, 59000, Lille
SLK-Kliniken Heilbronn GmbH
Klinik für Innere Medizin III, Am Gesundbrunnen 20-26, Neckargartach, Heilbronn
Universitaetsklinikum Essen AöR
Westdeutsches Tumorzentrum, Hufelandstrasse 55, Holsterhausen, Essen
Fondazione IRCCS Istituto Nazionale Dei Tumori
S.C. Oncologia Pediatrica, Via Giacomo Venezian 1, 20133, Milan
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOS Fase I, Largo Francesco Vito 1, 00168, Rome
Bambino Gesu Childrens Hospital
Dipartimento di Onco-Ematologia Pediatrica, Piazza Sant'Onofrio 4, 00165, Rome
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Osp. Infantile Regina Margherita, Piazza Polonia 94, 10126, Turin
Azienda Ospedaliera Universitaria Senese
U.O.C. Immunoterapia Oncologica, Strada Delle Scotte 14, 53100, Siena
Fondazione IRCCS Istituto Nazionale Dei Tumori
S.C. MEDICINA ONCOLOGICA 1, Via Giacomo Venezian 1, 20133, Milan
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
U.O. Oncologia Medica, Piazzale Spedali Civili 1, 25123, Brescia
Uniwersyteckie Centrum Kliniczne
Klinika Pediatrii, Hematologii i Onkologii, Ul. Debinki 7, 80-211, Gdansk
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Klinika Onkologii i Radioterapii, Ul. Wawelska 15, 02-034, Warsaw
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Klinika Nowotworów Płuca i Klatki Piersiowej, Klinika Gin Onkologicznej, Oddział Badań Wczesnych Faz, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Uniwersyteckie Centrum Kliniczne
Klinika Onkoligii i Radioterapii, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Serviço de Oncologia Médica, Rua Dr. Antonio Bernardino De Almeida, 4200-072, Porto
Hospital Universitario Hm Sanchinarro
Oncología, Calle Ona 10, 28050, Madrid
Hospital Universitari Vall D Hebron
Oncología, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Universitario 12 De Octubre
Oncología, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Universitario Fundacion Jimenez Diaz
Oncología, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Clinica Universidad De Navarra
Oncología, Avenue Pio XII 36, 31008, Pamplona
Sant Joan De Deu Barcelona Hospital
Oncología, Passeig De Sant Joan De Deu 2, 08950, Esplugues De Llobregat
Hospital Universitario La Paz
Oncología, Paseo De La Castellana 261, 28046, Madrid
Hospital Universitario Y Politecnico La Fe
Oncología, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Clinica Universidad De Navarra
Oncología, Calle Marquesado De Santa Marta 1, 28027, Madrid
Hospital Infantil Universitario Nino Jesus
Oncología, Avenida Menendez Pelayo 65, 28009, Madrid
Fir Huvh Fundacio Institut De Recerca Hospital Universitari Vall De Hebron
Oncología, Passeig De La Vall D'hebron 119-129, 08035, 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 | 2021-05-04 | 2021-05-10 | 2025-12-10 | ||
| Denmark | 2021-10-27 | 2021-11-24 | 2025-12-10 | ||
| France | 2021-10-29 | 2021-11-15 | 2025-12-10 | ||
| Germany | 2021-05-26 | 2021-06-30 | 2022-08-19 | ||
| Italy | 2021-03-15 | 2021-03-24 | 2025-12-10 | ||
| Poland | 2021-04-02 | 2021-04-07 | 2025-12-10 | ||
| Portugal | 2021-07-02 | 2021-07-07 | 2025-12-10 | ||
| Spain | 2021-04-28 | 2021-07-12 | 2025-12-10 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Urgent safety measures 1 · Art. 54 CTR
Urgent safety measure US-52561
- Event date
- 2024-10-17
- Submission date
- 2024-10-18
- In response to
- OTHER
- Member states affected
- Belgium, Denmark, France, Germany, Italy, Portugal, Spain, Poland
- Event description
- Gavreto (pralsetinib): “Severe infection”, also including
fatal and opportunistic infections, qualifies as a new
important identified risk. - Measures taken
- Protocol language to incorporate the following changes to
study conduct:
Monitor patients closely for infection and treat
appropriately according.
Withhold pralsetinib in the presence of infection (any
grade), regardless of investigator causality assessment of
the infection to pralsetinib, for a minimum of 7 days.
Resume pralsetinib only upon resolution of infection, i.e. <
Grade 1 and at a dose 100 mg less than the previous dose
prior to dose interruption.
Permanently discontinue pralsetinib for grade 4 infection.
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 393 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | d1_protocol-2023-507418-28-00-redacted | 7 |
| Protocol (for publication) | D4_Patient-facing-documents_Redaction memo | NA |
| Recruitment arrangements (for publication) | K_Recruitment arrangements_filenote | 1 |
| Recruitment arrangements (for publication) | K. Recruitment arrangement | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment and informed consent procedure form | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | NA |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_REDACTED | 1.0 |
| Recruitment arrangements (for publication) | K2_Document_additionnel_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Assent 3-11 Cohort A_FILE NOTE | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF ASSENT 3-11 Cohort B | 3 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Assent_ 12_17 Years_Cohort D TMB_FILE NOTE | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF main_Cohort M_FILE NOTE | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF main_Cohort N_FILE NOTE | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_ASSENT 3-11 Cohort D_FILE NOTE | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Assent_12_17_Years_ Cohort B NTRK1_2_3 | 4 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Assent_12_17_Years_ Cohort J BRAF III_FILE NOTE | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Assent_12_17_Years_ NGS Biomarker Eligibility Testing | 4 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Assent_12_17_Years_Cohort A ROS1_FILE NOTE | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Assent_12_17_Years_Cohort C ALK_FILE NOTE | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Assent_12_17_Years_Cohort E AKT1_2_3_FILE NOTE | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Assent_12_17_Years_Cohort H PIK3CA_FILE NOTE | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Assent_12_17_Years_Cohort K RET_FILE NOTE | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Assent_12-17_Years_Cohort L KRAS G12CL_FILE NOTE | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Assent_12-17_Years_Cohort M_FILE NOTE | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Assent_12-17_Years_Cohort N_FILE NOTE | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_main Cohort L KRAS G12C_FILE NOTE | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_main_ Cohort J BRAF III_FILE NOTE | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_main_ Cohort K RET_FILE NOTE | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_main_Cohort A ROS1_REDACTED | 7 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_main_Cohort B NTRK 123_REDACTED | 7 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_main_Cohort C ALK_FILE NOTE | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_main_Cohort D TMB_REDACTED | 6 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_main_Cohort E AKT1_2_3_FILE NOTE | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_main_Cohort H PIK3CA_REDACTED | 6 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_main_NGS Biomarker Eligibility Testing | 7 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_NGS BM Elig Test_Ages 7-11_Years | 3 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Optional Biopsy | 4 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Pregnant Partner | 4 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_RBR_12-17 years_REDACTED | 3 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_RBR_REDACTED | 3 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Treatment Beyond Progression | 3 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Treatment Beyond Progression 12-17 yo | 3 |
| Subject information and informed consent form (for publication) | L1_BO41932_ICF_Main_12-17y_Coh A | 6 |
| Subject information and informed consent form (for publication) | L1_BO41932_ICF_Main_12-17y_Coh N | 2 |
| Subject information and informed consent form (for publication) | L1_BO41932_ICF_Main_12-17y_KohB | 6 |
| Subject information and informed consent form (for publication) | L1_BO41932_ICF_Main_12-17y_KohC | 2 |
| Subject information and informed consent form (for publication) | L1_BO41932_ICF_Main_12-17y_KohL | 2 |
| Subject information and informed consent form (for publication) | L1_BO41932_ICF_Main_12-17y_KohM | 2 |
| Subject information and informed consent form (for publication) | L1_BO41932_ICF_Main_7-11y_Coh A | 3 |
| Subject information and informed consent form (for publication) | L1_BO41932_ICF_Main_7-11y_Coh B | 3 |
| Subject information and informed consent form (for publication) | L1_BO41932_ICF_Main_Adult_Coh A_redacted | 10 |
| Subject information and informed consent form (for publication) | L1_BO41932_ICF_Main_Adult_Coh L_redacted | 3 |
| Subject information and informed consent form (for publication) | L1_BO41932_ICF_Main_Adult_Koh M_redacted | 3 |
| Subject information and informed consent form (for publication) | L1_BO41932_ICF_Main_Adult_Koh N_redacted | 3 |
| Subject information and informed consent form (for publication) | L1_BO41932_ICF_Main_Adult_KohB_redacted | 11 |
| Subject information and informed consent form (for publication) | L1_BO41932_ICF_Main_Adult_KohC_redacted | 10 |
| Subject information and informed consent form (for publication) | L1_BO41932_ICF_Main_Parent_Coh A_redacted | 6 |
| Subject information and informed consent form (for publication) | L1_BO41932_ICF_Main_Parent_Coh L_redacted | 3 |
| Subject information and informed consent form (for publication) | L1_BO41932_ICF_Main_Parent_Coh N_redacted | 3 |
| Subject information and informed consent form (for publication) | L1_BO41932_ICF_Main_Parent_Koh B_redacted | 6 |
| Subject information and informed consent form (for publication) | L1_BO41932_ICF_Main_Parent_Koh C_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_BO41932_ICF_Main_Parent_Koh M_redacted | 3 |
| Subject information and informed consent form (for publication) | L1_BO41932_ICF_NGS__PArent | 3 |
| Subject information and informed consent form (for publication) | L1_BO41932_ICF_NGS_12-17y | 4 |
| Subject information and informed consent form (for publication) | L1_BO41932_ICF_NGS_7-11y | 2 |
| Subject information and informed consent form (for publication) | L1_BO41932_ICF_NGS_Adult | 7 |
| Subject information and informed consent form (for publication) | L1_BO41932_ICF_optbiopsy_12-17y | 3 |
| Subject information and informed consent form (for publication) | L1_BO41932_ICF_optbiopsy_Adult | 5 |
| Subject information and informed consent form (for publication) | L1_BO41932_ICF_RBR_Adult_redacted | 3 |
| Subject information and informed consent form (for publication) | L1_BO41932_ICF_treatmafterPD_Adult | 3 |
| Subject information and informed consent form (for publication) | L1_Privacy consent form other subjects | 1 |
| Subject information and informed consent form (for publication) | L1_Privacy consent form_Russian | NA |
| Subject information and informed consent form (for publication) | L1_Recruitment arrangement form | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 12-17 yr cohort K | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 12-17 yr cohort L | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 12-17 yr cohort M | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 12-17 yr cohort N | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 12-17 yr cohort A | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 12-17 yr cohort B | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 12-17 yr cohort C | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 12-17 yr cohort D | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 12-17 yr cohort E | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 12-17 yr cohort H | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 12-17 yr cohort I | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 12-17 yr cohort J | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 12-17 yr NGS prescreening | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 12-17 yr NGS remote prescreening | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 12-17 yr NGS remote prescreening_Bosnian | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 3-11 yr cohort A | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 3-11 yr cohort B | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 3-11 yr cohort D | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 7-11 yr NGS prescreening | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 7-11 yr NGS prescreening_Russian | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 7-11 yr NGS remote prescreening | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent 12-15 Cohort A | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent 12-15 Cohort B | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent 12-15 Cohort C | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent 12-15 Cohort D | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent 12-15 Cohort H | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent 12-15 Cohort J | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent 12-15 Cohort K | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent 12-15 Cohort L | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent 12-15 Cohort M | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent 12-15 Cohort N | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent 12-15 NGS | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent 3-11 Cohort A | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent 3-11 Cohort B | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent 3-11 Cohort D | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent 7-11 NGS | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent MAIN Cohort E 12 to 17 Years_FILE NOTE | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Cohort B REDACTED | 10 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Genetic Analysis | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main adult cohort J | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main adult cohort K | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main adult cohort L | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main adult cohort A | 6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main adult cohort B | 6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main adult cohort C | 6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main adult cohort D | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main adult cohort E | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main adult cohort H | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main adult cohort I | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main adult cohort M | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main adult cohort N | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main adult NGS prescreening | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main adult NGS prescreening_Russian | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main adult NGS prescreening_Ukrainian | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Cohort A | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Cohort B_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Cohort C | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Cohort D | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Cohort H | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Cohort J | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Cohort K | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Cohort L | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Cohort M | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Cohort N | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main NGS prescreening_Mandarin Chinese | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main parents cohort K | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main parents cohort L | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main parents cohort A | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main parents cohort B | 6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main parents cohort C | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main parents cohort D | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main parents cohort E | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main parents cohort H | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main parents cohort I | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main parents cohort J | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main parents cohort M | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main parents cohort N | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main parents NGS prescreening | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main parents NGS prescreening_Russian | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main parents remote NGS prescreening | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main parents remote NGS prescreening_Bosnian | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF NGS | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Biopsy | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Partner | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF RBR_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Survival FU | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ A _ 3-11_redacted | 0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ L_12-17_redacted | 0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ L_Adulte_redacted | 0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ L_Parents_redacted | 0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ MAIN COHORT I FILE NOTE | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ MAIN COHORT J FILE NOTE | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ MAIN COHORT K FILE NOTE | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ MAIN Cohort M FILE NOTE | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ RBR_kohorte K | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ RBR_kohorte M | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_15-17 arige_biomarkrtest_redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_15-17 arige_kohorte A_redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_15-17 arige_kohorte B_redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_15-17 arige_kohorte C_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_15-17 arige_kohorte K_redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_15-17 arige_kohorte L_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_15-17 arige_kohorte M_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_15-17 arige_kohorte N_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_A_12-17_redacted | 0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_A_adultes_redacted | 6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_A_Parents_redacted | 0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Asentimi Cohort L FILE NOTE | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Asentimiento Cohort A FILE NOTE | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Asentimiento Cohort B FILE NOTE | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Asentimiento Cohort K FILE NOTE | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Asentimiento Cohort M FILE NOTE | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Asentimiento B Cohort C FILE NOTE | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Asentimiento Cohort N _file note | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Ass MAIN Cohort D TMB_Redline Ages 12 to 17 Years FILE NOTE | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 12-14 NGS FIL.E NOTE | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent Cohort H PIKC3A Ages 12-17 Years FILE NOTE | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent Cohort I BRAF II Ages 12 to 17 YEARS FILE NOTE | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 12-17 Biomarker_EN | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 12-17 Biomarker_FR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 12-17 Biomarker_NL | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 12-17 Cohort A_EN | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 12-17 Cohort A_FR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 12-17 Cohort A_NL | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 12-17 CohortB_EN | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 12-17 CohortB_FR | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 12-17 CohortB_NL | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 12-17 CohortC_EN | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 12-17 CohortC_FR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 12-17 CohortC_NL | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 12-17 CohortD_EN | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 12-17 CohortD_FR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 12-17 CohortD_NL | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 12-17 CohortE_EN | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 12-17 CohortE_FR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 12-17 CohortE_NL | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 12-17 CohortF_EN | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 12-17 CohortF_FR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 12-17 CohortF_NL | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 12-17 CohortH_EN | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 12-17 CohortH_FR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 12-17 CohortH_NL | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 12-17 CohortI_EN | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 12-17 CohortI_FR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 12-17 CohortI_NL | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 12-17 CohortJ_EN | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 12-17 CohortJ_FR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 12-17 CohortJ_NL | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 12-17 CohortK_EN | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 12-17 CohortK_FR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 12-17 CohortK_NL | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 12-17 CohortL_EN | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 12-17 CohortL_FR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 12-17 CohortL_NL | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 12-17 CohortM_EN | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 12-17 CohortM_FR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 12-17 CohortM_NL | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 12-17 CohortN_EN | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 12-17 CohortN_FR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 12-17 CohortN_NL | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 3-11 Cohort A_EN | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 3-11 Cohort A_FR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 3-11 Cohort A_NL | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 3-11 CohortB_EN | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 3-11 CohortB_FR | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 3-11 CohortB_NL | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 7-11 Biomarker_EN | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 7-11 Biomarker_FR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 7-11 Biomarker_NL | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent Cohort J BRAF 12 to 17 Years FILE NOTE | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_B 3-11_redacted | 0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_B_12-17_redacted | 0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_B_adultes_redacted | 6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_B_Parents_redacted | 6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_biomarkr | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Biopsie adultes_redacted | 0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_biopsie parent_redacted | 0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Biopsie_12-17_redacted | 0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_C_12-17_redacted | 0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_C_adultes_redacted | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_C_parents_redacted | 0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Cohort C REDACTED | 11 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_D_adultes_redacted | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Deltagerinformation kohorte A | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Deltagerinformation kohorte B_Redacted | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Deltagerinformation kohorte C | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Deltagerinformation kohorte K | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Deltagerinformation kohorte L | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Deltagerinformation kohorte M | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Deltagerinformation kohorte N | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_E_ adultes_redacted | 0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_elig_12-17_redacted | 0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_elig_Adulte_clean | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_elig_Parent_clean | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_forldre biomarkr_redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_forldre kohorte A_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_forldre kohorte B_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_forldre kohorte C_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_forldre kohorte K_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_forldre kohorte L_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_forldre kohorte M_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_forldre kohorte N_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_forldre til valgfri biopsi | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_forldre ved sygdomsforvrring_ kohorte M | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_forldre ved sygdomsforvrring_kohorte A | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_forldre ved sygdomsforvrring_kohorte B | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_forldre ved sygdomsforvrring_kohorte C | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_forldre ved sygdomsforvrring_kohorte K | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_forldre ved sygdomsforvrring_kohorte L | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_forldre ved sygdomsforvrring_kohorte N | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Gravid partner | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_H_12-17_redacted | 0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_H_adultes_redacted | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_H_parents_redacted | 0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_I_Adulte_redacted | 0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ICF BO41932 BM EM0112 Biopsy_v2_ES_2021_05_31 | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_J_12-17_redacted | 0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_J_Adulte_redacted | 0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_J_Parents_redacted | 0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_K_12-17_redacted | 0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_K_Adulte_redacted | 0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_K_Parents_redacted | 0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_M_12-17_redacted | 0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_M_Adulte_redacted | 0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_M_Parents_redacted | 0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_MAIN Cohort L FILE NOTE | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_MAIN COHORT A REDACTED | 10 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_MAIN COHORT D FILE NOTE | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_MAIN COHORT E FILE NOTE | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Cohort H redacted | 10 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_MAIN Cohort N FILE NOTE | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF Biomarker_EN | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF Biomarker_FR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF Biomarker_NL | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_MAIN ICF Cohort A_EN | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_MAIN ICF Cohort A_FR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_MAIN ICF Cohort A_NL_REDACTED | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF CohortB_EN_REDACTED | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF CohortB_FR_REDACTED | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF CohortB_NL_REDACTED | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF CohortC_EN | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF CohortC_FR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF CohortC_NL_REDACTED | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF CohortD_EN | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF CohortD_FR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF CohortD_NL_REDACTED | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF CohortE_EN | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF CohortE_FR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF CohortE_NL | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF CohortF_EN | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF CohortF_FR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF CohortF_NL | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF CohortH_EN | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF CohortH_FR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF CohortH_NL | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF CohortI_EN | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF CohortI_FR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF CohortI_NL | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF CohortJ_EN | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF CohortJ_FR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF CohortJ_NL | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF CohortK_EN | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF CohortK_FR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF CohortK_NL | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF CohortL_EN | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF CohortL_FR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF CohortL_NL | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF CohortM_EN | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF CohortM_FR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF CohortM_NL | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF CohortN_EN | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF CohortN_FR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF CohortN_NL | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF RBR ICF All Cohorts_EN_REDACTED | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF RBR ICF All Cohorts_FR_REDACTED | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF RBR ICF All Cohorts_NL_REDACTED | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main NGS | 8 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_N_12 17_redacted | 0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_N_Adultes_redacted | 0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_N_parents_redacted | 0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_partenaire_clean | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PPA FILE NOTE | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PPA ICF_EN | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PPA ICF_FR | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PPA ICF_NL | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_RBR REDACTED | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_RBR_forldre_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_RBR_kohorte A | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_RBR_kohorte B_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_RBR_kohorte C | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_RBR_kohorte L | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_RBR_kohorte N | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_S13 Genomdokument | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_valgfri biopsi_ kohorte B | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_valgfri biopsi_kohorte A | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_valgfri biopsi_kohorte C | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_valgfri biopsi_kohorte K | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_valgfri biopsi_kohorte L | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_valgfri biopsi_kohorte M | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_valgfri biopsi_kohorte N | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ved sygdomsforvrring_kohorte A | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ved sygdomsforvrring_kohorte B | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ved sygdomsforvrring_kohorte C | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ved sygdomsforvrring_kohorte K | 1 |
| Subject information and informed consent form (for publication) | L2_SIS and ICF_ICF_Procedure_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L2_SIS and ICF_Sponsor_Statement_On_Use_Of_ICF_Model | 1.0 |
| Subject information and informed consent form (for publication) | L2_Your Rights as a Trial Participant | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol-synopsis_BE-DE 2023-507418-28-00 | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol-synopsis_BE-FR 2023-507418-28-00 | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol-synopsis_BE-NL 2023-507418-28-00 | 4.0 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_ENG-2023-507418-28-00 | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol-synopsis_ES 2023-507418-28-00 | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol-synopsis_FR 2023-507418-28-00 | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol-synopsis_IT 2023-507418-28-00 | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol-synopsis_PL 2023-507418-28-00 | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol-synopsis_PT 2023-507418-28-00 | 4.0 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-10 | Denmark | Acceptable 2024-07-11
|
2024-07-12 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-26 | Denmark | Acceptable 2025-03-13
|
2025-03-14 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-04-30 | Denmark | Acceptable 2025-07-25
|
2025-07-25 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-08-12 | Acceptable 2025-07-25
|
2025-08-12 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-09-19 | Denmark | Acceptable 2025-10-28
|
2025-10-28 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-01-21 | Acceptable | 2026-02-02 |