An open label, multicenter extension study in patients previously enrolled in a Genentch and/or F. Hoffmann-La Roche Ltd sponsored atezolizumab study (IMBRELLA B)

2023-506184-34-00 Protocol BO40729 Therapeutic confirmatory (Phase III) Ongoing, recruitment ended

Start 9 Aug 2019 · Status Ongoing, recruitment ended · 11 EU/EEA countries · 28 sites · Protocol BO40729

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Ongoing, recruitment ended
Participants planned 1,104
Countries 11
Sites 28

Advanced Malignancies

To provide continued treatment with atezolizumab-based therapy and/or combination/comparator agent(s) for eligible patients still on study treatment at the time of roll-over from the parent study who do not have access to the study treatment locally

Key facts

Sponsor
F. Hoffmann-La Roche AG
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Neoplasms [C04]
Trial duration
9 Aug 2019 → ongoing
Decision date (initial)
2024-07-10
Transition trial
Yes
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes
Funding sources
F. Hoffmann-La Roche Ltd

External identifiers

EU CT number
2023-506184-34-00
EudraCT number
2018-003352-20

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Others

To provide continued treatment with atezolizumab-based therapy and/or combination/comparator agent(s) for eligible patients still on study treatment at the time of roll-over from the parent study who do not have access to the study treatment locally

Secondary objectives 1

  1. To identify any new safety signal related to atezolizumab or atezolizumab administered with combination agent(s) in patients who are currently eligible to receive treatment with atezolizumab and have demonstrated clinical benefit

Conditions and MedDRA coding

Advanced Malignancies

VersionLevelCodeTermSystem organ class
21.1 LLT 10072740 Locally advanced breast cancer 10029104
20.0 PT 10033128 Ovarian cancer 100000004864
27.0 LLT 10027481 Metastatic melanoma 10029104
21.1 PT 10029522 Non-small cell lung cancer stage IV 100000004864
21.1 PT 10067946 Renal cell carcinoma 100000004864
26.1 PT 10060121 Squamous cell carcinoma of head and neck 100000004864
21.1 LLT 10076506 Castration-resistant prostate cancer 10029104
20.0 PT 10075566 Triple negative breast cancer 100000004864
21.0 LLT 10028228 Multiple myeloma 10029104
21.1 LLT 10065252 Solid tumor 10029104
27.0 LLT 10052362 Metastatic colorectal cancer 10029104
20.0 PT 10040808 Skin cancer 100000004864
21.1 PT 10061873 Non-small cell lung cancer 100000004864
20.0 LLT 10064467 Urothelial carcinoma 10029104

Regulatory references

Plan to share IPD
No
EU CT numberTitleSponsor
2024-516481-11-00 A Phase 3, Randomized, Open-Label, Controlled Study of Cabozantinib (XL184) in Combination with Atezolizumab vs Second Novel Hormonal Therapy (NHT) in Subjects with Metastatic Castration-Resistant Prostate Cancer Exelixis Inc.
2023-508010-42-00 A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Niraparib Maintenance Treatment in Patients with Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy Tesaro Inc.
2021-004149-19 A PHASE I-III, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF MULTIPLE THERAPIES IN COHORTS OF PATIENTS SELECTED ACCORDING TO BIOMARKER STATUS, WITH LOCALLY ADVANCED, UNRESECTABLE, STAGE III NON-SMALL CELL LUNG CANCER, ESTUDIO DE FASE I-III MULTICÉNTRICO PARA EVALUAR LA EFICACIA Y SEGURIDAD DE MÚLTIPLES TRATAMIENTOS EN COHORTES DE PACIENTES SELECCIONADOS BASÁNDOSE EN EL ESTADO DE LOS BIOMARCADORES, CON CÁNCER DE PULMÓN NO MICROCÍTICO EN ESTADIO III LOCALMENTE AVANZADO, NO RESECABLE, STUDIO MULTICENTRICO DI FASE I-III VOLTO A VALUTARE L’EFFICACIA E LA SICUREZZA DI DIVERSE TERAPIE, IN COORTI DI PAZIENTI SELEZIONATE IN BASE ALLO STATO DEI BIOMARCATORI, AFFETTI DA TUMORE POLMONARE NON A PICCOLE CELLULE IN STADIO III, LOCALMENTE AVANZATO, NON RESECABILE

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

  1. Signed extension study Informed Consent Form
  2. Eligible for continuing atezolizumab-based therapy at the time of rollover from the parent study, as per the parent study protocol or
  3. Eligible for continuing the comparator agent(s) in a Genentech- or Roche-sponsored study as per the parent study protocol, with no access to commercially available comparator agent
  4. Time between the last dose of treatment received in parent study and first dose in extension study is no longer than the interruption period allowed in the parent study. First dose of study treatment in this extension study will be received within 7 days of the treatment interruption window allowed by the parent study
  5. Continue to benefit from atezolizumab-based study treatment or from the comparator at the time of roll-over from the parent study as assessed by the investigator
  6. Able to comply with this extension study, in the investigator's judgment
  7. Negative blood pregnancy test within 7 days prior to start of study treatment in women of childbearing potential
  8. Will comply with contraception criteria

Exclusion criteria 8

  1. Meet any of the study treatment discontinuation criteria specified in the parent study at the time of enrolment in this extension study
  2. Study treatment or comparator agent is commercially marketed in the patient's country for the patient-specific disease and is accessible to the patient
  3. Treatment with any anti-cancer treatment (other than treatment permitted in the parent study) during the time between last treatment in the parent study and the first dose of study treatment in this extension study
  4. Permanent discontinuation of atezolizumab for any reason during the parent study or during the time between last treatment in the parent study and the first dose of study treatment in this extension study (if applicable) Exception: Patients who permanently discontinued atezolizumab from parent studies that permit patients to continue treatment with the combination agent(s) alone after permanently discontinuing atezolizumab are eligible to enroll in this study.
  5. Ongoing serious adverse event(s) that has not resolved to baseline level or Grade ≤1 from the parent study or during the time between the last treatment in the parent study and the first dose of study treatment in this extension study
  6. Any condition that, in the opinion of the investigator, would interfere with the interpretation of patient safety or place the patient at high risk for treatment-related complications
  7. Concurrent participation in any therapeutic clinical trial (other than the parent study)
  8. Pregnant or lactating, or intending to become pregnant during this extension study and for the period after the last dose of study treatment specified in the designated RSI

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Patients who are deriving clinical benefit from the treatment with atezolizumab-based therapy and/or comparator agent(s) according to investigator assessment.

Investigational products

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

Test 19

Paclitaxel 6 mg/ml Concentrate for Solution for Infusion

PRD2002567 · Product

Active substance
Paclitaxel
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS USE
Max daily dose
261.00 mg milligram(s)
Max total dose
4698.00 mg milligram(s)
Max treatment duration
120 Month(s)
Authorisation status
Authorised
ATC code
L01CD01 — PACLITAXEL
Marketing authorisation
PL 20075/0128
MA holder
ACCORD HEALTHCARE LIMITED
MA country
United Kingdom
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

RO7047650

PRD11197468 · Product

Active substance
Cabozantinib
Other product name
Cabozantinib
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
60 mg milligram(s)
Max total dose
7560.00 mg milligram(s)
Max treatment duration
120 Month(s)
Authorisation status
Not Authorised
MA holder
EXELIXIS
Paediatric formulation
No
Orphan designation
No

Sutent 12.5 mg hard capsules

PRD3432966 · Product

Active substance
Sunitinib
Substance synonyms
SU-011,248, N-(2-(DIETHYLAMINO)ETHYL)-5-((Z)-(5-FLUORO-2-OXO-1,2-DIHYDRO-3H-INDOL-3-YLIDENE)METHYL)-2,4-DIMETHYL-1H-PYRROLE-3-CARBOXAMIDE
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL USE
Max daily dose
50.00 mg milligram(s)
Max total dose
8400.00 mg milligram(s)
Max treatment duration
120 Month(s)
Authorisation status
Authorised
ATC code
L01EX01 — -
Marketing authorisation
EU/1/06/347/001
MA holder
PFIZER EUROPE MA EEIG
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sutent 25 mg hard capsules

PRD3432965 · Product

Active substance
Sunitinib
Substance synonyms
SU-011,248, N-(2-(DIETHYLAMINO)ETHYL)-5-((Z)-(5-FLUORO-2-OXO-1,2-DIHYDRO-3H-INDOL-3-YLIDENE)METHYL)-2,4-DIMETHYL-1H-PYRROLE-3-CARBOXAMIDE
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL USE
Max daily dose
50.00 mg milligram(s)
Max total dose
8400.00 mg milligram(s)
Max treatment duration
120 Month(s)
Authorisation status
Authorised
ATC code
L01EX01 — -
Marketing authorisation
EU/1/06/347/002
MA holder
PFIZER EUROPE MA EEIG
MA country
Liechtenstein
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sutent 50 mg hard capsules

PRD3432975 · Product

Active substance
Sunitinib
Substance synonyms
SU-011,248, N-(2-(DIETHYLAMINO)ETHYL)-5-((Z)-(5-FLUORO-2-OXO-1,2-DIHYDRO-3H-INDOL-3-YLIDENE)METHYL)-2,4-DIMETHYL-1H-PYRROLE-3-CARBOXAMIDE
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL USE
Max daily dose
50.00 mg milligram(s)
Max total dose
8400.00 mg milligram(s)
Max treatment duration
120 Month(s)
Authorisation status
Authorised
ATC code
L01EX01 — -
Marketing authorisation
EU/1/06/347/003
MA holder
PFIZER EUROPE MA EEIG
MA country
Liechtenstein
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sutent 50 mg hard capsules

PRD3432964 · Product

Active substance
Sunitinib
Substance synonyms
SU-011,248, N-(2-(DIETHYLAMINO)ETHYL)-5-((Z)-(5-FLUORO-2-OXO-1,2-DIHYDRO-3H-INDOL-3-YLIDENE)METHYL)-2,4-DIMETHYL-1H-PYRROLE-3-CARBOXAMIDE
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL USE
Max daily dose
50.00 mg milligram(s)
Max total dose
8400.00 mg milligram(s)
Max treatment duration
120 Month(s)
Authorisation status
Authorised
ATC code
L01EX01 — -
Marketing authorisation
EU/1/06/347/006
MA holder
PFIZER EUROPE MA EEIG
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sutent 25 mg hard capsules

PRD3432963 · Product

Active substance
Sunitinib
Substance synonyms
SU-011,248, N-(2-(DIETHYLAMINO)ETHYL)-5-((Z)-(5-FLUORO-2-OXO-1,2-DIHYDRO-3H-INDOL-3-YLIDENE)METHYL)-2,4-DIMETHYL-1H-PYRROLE-3-CARBOXAMIDE
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL USE
Max daily dose
50.00 mg milligram(s)
Max total dose
8400.00 mg milligram(s)
Max treatment duration
120 Month(s)
Authorisation status
Authorised
ATC code
L01EX01 — -
Marketing authorisation
EU/1/06/347/005
MA holder
PFIZER EUROPE MA EEIG
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sutent 12.5 mg hard capsules

PRD3432967 · Product

Active substance
Sunitinib
Substance synonyms
SU-011,248, N-(2-(DIETHYLAMINO)ETHYL)-5-((Z)-(5-FLUORO-2-OXO-1,2-DIHYDRO-3H-INDOL-3-YLIDENE)METHYL)-2,4-DIMETHYL-1H-PYRROLE-3-CARBOXAMIDE
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL USE
Max daily dose
50.00 mg milligram(s)
Max total dose
8400.00 mg milligram(s)
Max treatment duration
120 Month(s)
Authorisation status
Authorised
ATC code
L01EX01 — -
Marketing authorisation
EU/1/06/347/004
MA holder
PFIZER EUROPE MA EEIG
MA country
Liechtenstein
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

RO7250726

PRD11252720 · Product

Active substance
Niraparib
Other product name
Niraparib
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL USE
Max daily dose
200.00 mg milligram(s)
Max total dose
33600.00 mg milligram(s)
Max treatment duration
120 Month(s)
Authorisation status
Not Authorised
MA holder
GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LIMITED
Paediatric formulation
No
Orphan designation
No

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
INTRAVENOUS USE
Max daily dose
1200.00 mg milligram(s)
Max total dose
10080.00 mg milligram(s)
Max treatment duration
120 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
No

Alecensa 150 mg hard capsules

PRD4815707 · Product

Active substance
Alectinib Hydrochloride
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL USE
Max daily dose
1200.00 mg milligram(s)
Max total dose
151200.00 mg milligram(s)
Max treatment duration
120 Month(s)
Authorisation status
Authorised
ATC code
L01ED03 — -
Marketing authorisation
EU/1/16/1169/001
MA holder
ROCHE REGISTRATION GMBH
MA country
Liechtenstein
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Alecensa 150 mg hard capsules

PRD5956677 · Product

Active substance
Alectinib Hydrochloride
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL USE
Max daily dose
1200.00 mg milligram(s)
Max total dose
151200.00 mg milligram(s)
Max treatment duration
120 Month(s)
Authorisation status
Authorised
ATC code
L01ED03 — -
Marketing authorisation
EU/1/16/1169/002
MA holder
ROCHE REGISTRATION GMBH
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

ALIMTA 500 mg powder for concentrate for solution for infusion

PRD2433080 · Product

Active substance
Pemetrexed
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS USE
Max daily dose
1415.00 mg milligram(s)
Max total dose
8490.00 mg milligram(s)
Max treatment duration
120 Month(s)
Authorisation status
Authorised
ATC code
L01BA04 — -
Marketing authorisation
EU/1/04/290/001
MA holder
ELI LILLY NEDERLAND B.V.
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Zelboraf

PRD9910516 · Product

Active substance
Vemurafenib
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
1440.00 mg milligram(s)
Max total dose
241920.00 mg milligram(s)
Max treatment duration
120 Month(s)
Authorisation status
Not Authorised
MA holder
F. HOFFMANN-LA ROCHE LTD
Paediatric formulation
No
Orphan designation
No

Zelboraf

PRD200064 · Product

Active substance
Vemurafenib
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
1440.00 mg milligram(s)
Max total dose
241920.00 mg milligram(s)
Max treatment duration
120 Month(s)
Authorisation status
Not Authorised
MA holder
F. HOFFMANN-LA ROCHE LTD
Paediatric formulation
No
Orphan designation
No

Cotellic

PRD10777048 · Product

Active substance
Cobimetinib
Other product name
RO5514041
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
60.00 mg milligram(s)
Max total dose
7560.00 mg milligram(s)
Max treatment duration
120 Month(s)
Authorisation status
Not Authorised
MA holder
F. HOFFMANN-LA ROCHE LTD
Paediatric formulation
No
Orphan designation
No

Cotellic

PRD10784718 · Product

Active substance
Cobimetinib
Other product name
RO5514041
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
60.00 mg milligram(s)
Max total dose
7560.00 mg milligram(s)
Max treatment duration
120 Month(s)
Authorisation status
Not Authorised
MA holder
F. HOFFMANN-LA ROCHE LTD
Paediatric formulation
No
Orphan designation
No

Venclexta, Venclyxto

PRD9859718 · Product

Active substance
Venetoclax
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
1200.00 mg milligram(s)
Max total dose
134400.00 mg milligram(s)
Max treatment duration
120 Month(s)
Authorisation status
Not Authorised
MA holder
ABBVIE, INC.
Paediatric formulation
No
Orphan designation
Yes
Orphan designation number
EU/3/17/1954

Alectinib (Alecensa)

PRD9859689 · Product

Active substance
Alectinib
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL USE
Max daily dose
1200.00 mg milligram(s)
Max total dose
151200.00 mg milligram(s)
Max treatment duration
120 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

213 Total trials 63 Recruiting 141 Ended
Commercial
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 7

OrganisationCity, countryDuties
Almac Clinical Technologies LLC
ORG-100043036
 Souderton, United States Interactive response technologies (IRT)
Almac Clinical Technologies LLC
ORG-100043036
 Souderton, United States Interactive response technologies (IRT)
Scout Clinical
ORG-100042228
 Dallas, United States Other
Icon Clinical Research Limited
ORG-100008322
 Dublin 18, Ireland On site monitoring, Code 10, Code 12, Code 13, Other, Code 5, Data management, Code 8
Medidata Solutions Inc.
ORG-100016256
 New York, United States Interactive response technologies (IRT)
Novasco
ORG-100046671
 Paris, France Other
Optimapharm d.o.o.
ORG-100042749
 Grad Zagreb, Croatia Other

Locations

11 EU/EEA countries · 28 investigational sites

By country

CountryMS statusPlanned subjectsSites
Belgium Ongoing, recruitment ended 9 2
Czechia Ongoing, recruitment ended 2 1
France Ongoing, recruitment ended 24 2
Germany Ongoing, recruitment ended 16 8
Greece Ongoing, recruitment ended 5 1
Hungary Ended 6 1
Latvia Ongoing, recruitment ended 4 1
Poland Ongoing, recruitment ended 20 7
Romania Ended 8 3
Slovakia Ended 2 1
Spain Ongoing, recruitment ended 8 1
Rest of world
Hong Kong, Brazil, Mexico, Australia, United Kingdom, Canada, Thailand, Russian Federation, Chile, Ukraine, Taiwan, Switzerland, United States, Guatemala, Korea, Republic of, Singapore
 — 1,000 —

Investigational sites

Belgium

2 sites · Ongoing, recruitment ended
UZ Brussel
Department of Medical Oncology, Laarbeeklaan 101, 1090, Jette
UZ Leuven
Department of Medical Oncology, Herestraat 49, 3000, Leuven

Czechia

1 site · Ongoing, recruitment ended
Masarykuv Onkologicky Ustav
Department of Clinical Oncology, Zluty Kopec 543/7, Stare Brno, Brno-Stred

France

2 sites · Ongoing, recruitment ended
Centre Hospitalier Regional De Marseille
CEPCM (Centre d’Essais Précoces en Cancérologie de Marseille), 264 Rue Saint Pierre, 13005, Marseille
Institut Gustave Roussy
Département d’Innovation Thérapeutiqueet Essais Précoces, 39 Rue Camille Desmoulins, 94805, Villejuif Cedex

Germany

8 sites · Ongoing, recruitment ended
Universitaetsklinikum Ulm AöR
Klinik für Urologie, Albert-Einstein-Allee 23, Eselsberg, Ulm
Universitaetsklinikum Schleswig-Holstein AöR
Department of Dermatology, Ratzeburger Allee 160, 23538, Luebeck
Universitaetsklinikum Tuebingen AöR
Department für Frauengesund heit, Calwerstrasse 7, Innenstadt, Tuebingen
Asklepios Klinik Gauting GmbH
Oncology, Robert-Koch-Allee 2, 82131, Gauting
KEM I Evang. Kliniken Essen-Mitte gGmbH
Department of internal Medicine/Oncology, Henricistrasse 92, Huttrop, Essen
Universitaetsklinikum Tuebingen AöR
Klinik für Urologie (Studienzentrale), Hoppe-Seyler-Strasse 3, Nordstadt, Tuebingen
Lungenfachklinik Immenhausen
Pneumologische Onkologie, Robert Koch Strasse 3, 34376, Immenhausen
Medical Center - University Of Freiburg
Klinik für Innere Medizin I, Hematology, Oncology and Stem Cell Transplantatio n, Hugstetter Strasse 55, Stuehlinger, Freiburg Im Breisgau

Greece

1 site · Ongoing, recruitment ended
Metropolitan Hospital
1st Dept of Oncology, Ethnarchi Makariou 11, 185 47, Pireas

Hungary

1 site · Ended
Orszagos Onkologiai Intezet
Bőrgyógyászati Osztály, Rath Gyorgy Utca 7-9, Kerulet, Budapest XII

Latvia

1 site · Ongoing, recruitment ended
Rigas Austrumu kliniska universitates slimnica SIA
Oncology Clinic, Hipokrata Iela 4, 1079, Riga

Poland

7 sites · Ongoing, recruitment ended
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Klinika Nowotworów Tkanek Miękkich, Kości I Czerniaków, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Dolnoslaskie Centrum Onkologii Pulmonologii I Hematologii
Oddział Urologii, Pl. Ludwika Hirszfelda 12, 53-413, Wroclaw
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Ambulatorium Chemioterapii, Ul. Izabeli Romanowskiej 2, 85-796, Bydgoszcz
Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy
Oddział III – Chorób Płuc z Pododdziałem Onkologicznym, Ul. Gabriela Narutowicza 80, 05-400, Otwock
Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
Oddział Dzienny Chemioterapii i Hematologii Onkologicznej, Ul. Ks. Jozefa Bielawskiego 18, 36-200, Brzozow
Uniwersytecki Szpital Kliniczny W Poznaniu
Oddział Chemioterapii, Ul. Augustyna Szamarzewskiego 84, 60-569, Poznan
Europejskie Centrum Zdrowia Otwock Sp. z o.o.
Oddział Onkologii Klinicznej i Chemioterapii, Ul. Borowa 14/18, 05-400, Otwock

Romania

3 sites · Ended
Institutul Regional De Oncologie Iasi
Medical Oncology, Strada Sararie 177b, 700451, Iasi
Centrul De Oncologie SF Nectarie S.R.L.
Medical Oncology, Strada Caracal Nr 109, 200542, Craiova
Oncomed S.R.L.
Oncology, Strada Porumbescu Ciprian 57-59, 300239, Timisoara

Slovakia

1 site · Ended
University Hospital Bratislava
Clinic of Pneumology and phthisiology – Department of Clinical Oncology, Ruzinovska 6, Ruzinov, Bratislava

Spain

1 site · Ongoing, recruitment ended
Hospital Universitario Hm Sanchinarro
Medical oncology, Calle Ona 10, 28050, Madrid

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 2019-08-21 2019-08-21 2023-02-14
Czechia 2021-09-02 2021-09-02 2021-12-09
France 2019-09-30 2019-09-30 2024-08-19
Germany 2019-10-09 2019-10-09 2024-12-19
Greece 2020-10-07 2020-10-07 2021-01-27
Hungary 2020-07-09 2024-10-07 2020-07-09 2020-10-14
Latvia 2020-04-07 2020-04-07 2020-06-30
Poland 2020-02-27 2020-02-27 2025-03-24
Romania 2021-09-02 2025-12-10 2021-09-02 2023-03-01
Slovakia 2020-05-14 2024-10-07 2020-05-14 2022-03-22
Spain 2019-08-09 2019-08-09 2023-07-12

Results and documents

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

Documents 89 files

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

TypeTitleVersion
Protocol (for publication) D1_Protocol_2023-506184-34-00_Greek_redacted 9
Protocol (for publication) D1_Protocol_2023-506184-34-00_redacted 9
Recruitment arrangements (for publication) K_BE_Recruitment Arrangements_Placeholder document 1
Recruitment arrangements (for publication) K_CZ_Recruitment Arrangements_Placeholder document 1
Recruitment arrangements (for publication) K_EL_Recruitment Arrangements_Placeholder document 1
Recruitment arrangements (for publication) K_ES_Recruitment Arrangements_Placeholder document 1
Recruitment arrangements (for publication) K_FR_Recruitment Arrangements_Placeholder document 1
Recruitment arrangements (for publication) K_LV_Recruitment Arrangements_Placeholder document 1
Recruitment arrangements (for publication) K_RO_Recruitment Arrangement_Placeholder document 1
Recruitment arrangements (for publication) K1_DE_Recruitment Procedure 1
Recruitment arrangements (for publication) K1_PL_Recruitment Procedure_Polish 1
Subject information and informed consent form (for publication) L1_BE_SIS-ICF_Addendum Cabozantinib_Dutch 1.0
Subject information and informed consent form (for publication) L1_BE_SIS-ICF_Addendum Cabozantinib_French 1.0
Subject information and informed consent form (for publication) L1_BE_SIS-ICF_Main_Dutch_redacted 8.1
Subject information and informed consent form (for publication) L1_BE_SIS-ICF_Main_French_redacted 8.1
Subject information and informed consent form (for publication) L1_BE_SIS-ICF_Pregnancy_Dutch 1.1
Subject information and informed consent form (for publication) L1_BE_SIS-ICF_Pregnancy_French 1.1
Subject information and informed consent form (for publication) L1_CZ_SIS-ICF_Addendum_Czech 2.0
Subject information and informed consent form (for publication) L1_CZ_SIS-ICF_Crossover_Czech 1.0
Subject information and informed consent form (for publication) L1_CZ_SIS-ICF_Data GDPR_Czech 2.0
Subject information and informed consent form (for publication) L1_CZ_SIS-ICF_Data GDPR_Czech_Highlighted 2.0
Subject information and informed consent form (for publication) L1_CZ_SIS-ICF_Main_Czech_Redacted 8.0
Subject information and informed consent form (for publication) L1_CZ_SIS-ICF_Main_Czech_redacted_Highlighted 8.0
Subject information and informed consent form (for publication) L1_CZ_SIS-ICF_Pregnant Partner_Czech 1.0
Subject information and informed consent form (for publication) L1_CZ_SIS-ICF_Treatment Continuation_Czech 2.0
Subject information and informed consent form (for publication) L1_CZ_SIS-ICF_Treatment Continuation_Czech_Highlighted 2.0
Subject information and informed consent form (for publication) L1_DE_SIS-ICF_Addendum Cabozantinib_German 1.1
Subject information and informed consent form (for publication) L1_DE_SIS-ICF_Addendum Cobimetinib_German 2.1
Subject information and informed consent form (for publication) L1_DE_SIS-ICF_Addendum Paclitaxel_German 2.1
Subject information and informed consent form (for publication) L1_DE_SIS-ICF_Addendum Vemurafenib_German 1.1
Subject information and informed consent form (for publication) L1_DE_SIS-ICF_Main_German_redacted 8.1
Subject information and informed consent form (for publication) L1_DE_SIS-ICF_Pregnant partner_German 1.2
Subject information and informed consent form (for publication) L1_EL_SIS-ICF_Addendum Bevacizumab_Greek 1.0
Subject information and informed consent form (for publication) L1_EL_SIS-ICF_Addendum Cabozantinib_Greek 1.0
Subject information and informed consent form (for publication) L1_EL_SIS-ICF_Addendum Cobimetinib_Greek 2.0
Subject information and informed consent form (for publication) L1_EL_SIS-ICF_Main_Greek_redacted 8.0
Subject information and informed consent form (for publication) L1_EL_SIS-ICF_Pregnant partner_Greek 1.0
Subject information and informed consent form (for publication) L1_EL_SISI-ICF_Scout_Greek 1.1
Subject information and informed consent form (for publication) L1_ES_SIS-ICF_Addendum Alectinib_Spanish 6.0
Subject information and informed consent form (for publication) L1_ES_SIS-ICF_Addendum Cobimetinib_Spanish 2.0
Subject information and informed consent form (for publication) L1_ES_SIS-ICF_Addendum Niraparib_Spanish 1.0
Subject information and informed consent form (for publication) L1_ES_SIS-ICF_Addendum Venetoclax_Spanish 1.0
Subject information and informed consent form (for publication) L1_ES_SIS-ICF_Main_Spanish_redacted 8.1
Subject information and informed consent form (for publication) L1_ES_SIS-ICF_Pregnant partner_Spanish 1.1
Subject information and informed consent form (for publication) L1_ES_SIS-ICF_Scout_Spanish_Redacted 1.1
Subject information and informed consent form (for publication) L1_FR_SIS-ICF_Adults_French_Redacted 6.1
Subject information and informed consent form (for publication) L1_FR_SIS-ICF_Cabozantinib Addendum_French 1.0
Subject information and informed consent form (for publication) L1_FR_SIS-ICF_Main_French_Redacted 8.0
Subject information and informed consent form (for publication) L1_FR_SIS-ICF_Partner_French 1.0
Subject information and informed consent form (for publication) L1_LV_SIS-ICF_Addendum PEMETREXED_Latvian 2.0
Subject information and informed consent form (for publication) L1_LV_SIS-ICF_Addendum PEMETREXED_Russian 2.0
Subject information and informed consent form (for publication) L1_LV_SIS-ICF_Main_Latvian_redacted 8.0
Subject information and informed consent form (for publication) L1_LV_SIS-ICF_Main_Russian_redacted 8.0
Subject information and informed consent form (for publication) L1_LV_SIS-ICF_Pregnant Partner_Latvian 1.1
Subject information and informed consent form (for publication) L1_LV_SIS-ICF_Pregnant Partner_Russian 1.1
Subject information and informed consent form (for publication) L1_PL_SIS-ICF_Addendum Cabozantinib_Polish 1.0
Subject information and informed consent form (for publication) L1_PL_SIS-ICF_Addendum Cobimetinib_Polish 2.0
Subject information and informed consent form (for publication) L1_PL_SIS-ICF_Main_Polish_redacted 8.0
Subject information and informed consent form (for publication) L1_PL_SIS-ICF_Pregnant Partner_Polish 1.0
Subject information and informed consent form (for publication) L1_PL_SIS-ICF_Scout_Polish_redacted 1.2
Subject information and informed consent form (for publication) L1_RO_SIS-ICF_Main_Redacted 8.0
Subject information and informed consent form (for publication) L1_RO_SIS-ICF_Main_Romanian_Redacted 8.0
Subject information and informed consent form (for publication) L1_RO_SIS-ICF_Partner 1.0
Subject information and informed consent form (for publication) L1_RO_SIS-ICF_Partner_Romanian 1.0
Subject information and informed consent form (for publication) L1_RO_SIS-ICF_Scout 1.0
Subject information and informed consent form (for publication) L1_RO_SIS-ICF_Scout_Romanian 1.0
Subject information and informed consent form (for publication) L2_CZ_Other Subject Material_Subject Participation Card_Czech 2
Subject information and informed consent form (for publication) L2_EL_Other Subject Material_Scout ICF Tax Language_Greek 2.0
Subject information and informed consent form (for publication) L2_EL_Other Subject Material_Scout Taxable Payments Letter_Greek 3.0
Subject information and informed consent form (for publication) L2_EL_Other Subject Material_Scout Travel confirmation Email communication_Greek 1.0
Subject information and informed consent form (for publication) L2_RO_Other Subject Material_Scout Email Communication_Romanian 1.0
Subject information and informed consent form (for publication) L2_RO_Other Subject Material_Scout Taxable Payments Letter 3.0
Subject information and informed consent form (for publication) L2_RO_Other Subject Material_Scout Taxable Payments Letter_Romanian 3.0
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Pemetrexed_Placeholder document 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Sunitinib_Placeholder document 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_Paclitaxel_Placeholder document 1
Synopsis of the protocol (for publication) D1_Lay Protocol Summary_2023-506184-34-00 1.0
Synopsis of the protocol (for publication) D1_Lay Protocol Summary_2023-506184-34-00_Czech 1.0
Synopsis of the protocol (for publication) D1_Lay Protocol Summary_2023-506184-34-00_Dutch 1.0
Synopsis of the protocol (for publication) D1_Lay Protocol Summary_2023-506184-34-00_French 1.0
Synopsis of the protocol (for publication) D1_Lay Protocol Summary_2023-506184-34-00_German 1.0
Synopsis of the protocol (for publication) D1_Lay Protocol Summary_2023-506184-34-00_Polish 1.0
Synopsis of the protocol (for publication) D1_Lay Protocol Summary_2023-506184-34-00_Romanian 1.0
Synopsis of the protocol (for publication) D1_Lay Protocol Summary_2023-506184-34-00_Spanish 1.0
Synopsis of the protocol (for publication) D1_Protocol Synopsis_2023-506184-34-00_Czech 9
Synopsis of the protocol (for publication) D1_Protocol Synopsis_2023-506184-34-00_French 9
Synopsis of the protocol (for publication) D1_Protocol Synopsis_2023-506184-34-00_Greek 9
Synopsis of the protocol (for publication) D1_Protocol Synopsis_2023-506184-34-00_Polish 8
Synopsis of the protocol (for publication) D1_Protocol Synopsis_2023-506184-34-00_Romanian 9

Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-05-30 Germany Acceptable
2024-07-08
 2024-07-08
2 SUBSTANTIAL MODIFICATION SM-1 2024-11-04 Germany Acceptable
2025-02-24
 2025-02-24
3 SUBSTANTIAL MODIFICATION SM-2 2025-06-18 Germany Acceptable 2025-07-31
4 NON SUBSTANTIAL MODIFICATION NSM-1 2025-08-04 2025-08-04
5 SUBSTANTIAL MODIFICATION SM-3 2025-08-07 Germany Acceptable 2025-09-17
6 SUBSTANTIAL MODIFICATION SM-4 2025-08-21 Acceptable 2025-11-10
7 SUBSTANTIAL MODIFICATION SM-5 2026-01-30 Germany Acceptable
2026-04-07
 2026-04-07

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