Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
577
Countries
15
Sites
76
Advanced Colorectal Cancer with KRAS G12C Mutation
To compare the efficacy of adagrasib in combination with cetuximab versus chemotherapy (FOLFIRI or mFOLFOX6) administered in the second-line treatment setting to patients with CRC with KRAS G12C mutation.
Key facts
- Sponsor
- Mirati Therapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 30 Nov 2021 → ongoing
- Decision date (initial)
- 2023-12-15
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Mirati Therapeutics, Inc.
External identifiers
- EU CT number
- 2023-506241-30-00
- EudraCT number
- 2020-004048-27
- ClinicalTrials.gov
- NCT04793958
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Therapy, Pharmacokinetic, Efficacy
To compare the efficacy of adagrasib in combination with cetuximab versus chemotherapy (FOLFIRI or mFOLFOX6) administered in the second-line treatment setting to patients with CRC with KRAS G12C mutation.
Secondary objectives 4
- To evaluate secondary efficacy endpoints in the study population.
- To evaluate the safety and tolerability in the study population.
- To evaluate the pharmacokinetics (PK) of adagrasib administered in combination with cetuximab.
- To evaluate health-related quality of life (HRQOL) and cancer-related symptoms in the study population.
Conditions and MedDRA coding
Advanced Colorectal Cancer with KRAS G12C Mutation
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | PT | 10052358 | Colorectal cancer metastatic | 100000004864 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Phase 3 of MRTX849 With Cetuximab vs Chemotherapy with Colorectal Cancer With KRAS G12C Mutation In all cohorts, adagrasib will be administered orally BID on a continuous basis.
Eligible patients will be randomized 1:1 to the experimental arm (adagrasib with cetuximab) or the control arm (FOLFIRI or mFOLFOX6 chemotherapy). Randomization will be stratified by:
1. Region (USA/Canada vs. other),
2. Time to disease progression after beginning first-line treatment (<6 months vs. ≥ 6 months).
The requirements for tumor KRAS G12C for determining eligibility are presented in Table 1 and Figure 1. The Schedule of Assessments is presented in Table 2.
Study treatment will be expressed in 4-week (28 day) cycles. Patients randomized to the experimental arm will receive adagrasib 600 mg BID and cetuximab 500 mg/m2 by intravenous (IV) infusion every 2 weeks (ie, Days 1 and 15 of each treatment cycle).
Patients randomized to the chemotherapy control arm will receive FOLFIRI or mFOLFOX6 depending on their first-line treatment regimen. Patients who received prior irinotecan will receive mFOLFOX6; patients who received prior oxaliplatin will receive FOLFIRI. In the chemotherapy control arm, patients will receive appropriate pre-medications followed by either:
FOLFIRI administered on Days 1 and 15 of each cycle:
irinotecan 180 mg/m² IV,
folinic acid 400 mg/m² IV, and
fluorouracil 400 mg/m² given as an IV bolus, then 2400 mg/m² given as a continuous infusion over 46 48 hours.
OR
mFOLFOX6 administered on days 1 and 15 of each cycle:
oxaliplatin 85 mg/m² IV,
folinic acid 400 mg/m² IV, and
fluorouracil 400 mg/m² given as an IV bolus, then 2400 mg/m² given as a continuous infusion over 46 48 hours.
AND, OPTIONALLY
A VEGF/VEGFR inhibitor (bevacizumab or locally approved bevacizumab biosimilar, ramucirumab, or ziv-aflibercept, at the discretion of the Investigator) used as local standard-of-care may be given as a concomitant therapy with control arm chemotherapy in accordance to package labeling at the discretion of the Investigator.
|
Randomised Controlled | None | Experimental arm: Study treatment will be expressed in 4-week (28 day) cycles. Patients randomized to the experimental arm will receive MRTX849 600 mg BID and cetuximab 500 mg/m2 by intravenous (IV) infusion every 2 weeks, i.e., Days 1 and 15 of each treatment cycle. Chemotherapy arm: Patients randomized to the chemotherapy control arm will receive FOLFIRI or mFOLFOX6 depending on their first-line treatment regimen. Patients who received prior irinotecan will receive mFOLFOX6; patients who received prior oxaliplatin will receive FOLFIRI. In the chemotherapy control arm, patients will receive appropriate pre-medications followed by either FLOFIRI or mFOLFOX5 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Histologically confirmed diagnosis of colorectal carcinoma G12C mutation in tumor tissue.
- Prior receipt of 1st line treatment in advanced CRC with a fluoropyrimidine-based chemotherapy regimen containing either oxaliplatin or irinotecan, and radiographically documented progression of disease on or after treatment.
Exclusion criteria 3
- Prior treatment with both an oxaliplatin-and irinotecan-based regimen for CRC, concurrently or successively, in any setting (neoadjuvant, adjuvant or advanced).
- Prior treatment with a therapy targeting KRAS G12C mutation (e.g., sotorasib).
- Prior treatment with an anti-EGFR antibody (e.g., cetuximab or panitumumab).
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Overall Survival (OS)
- Progression-free Survival (PFS)
Secondary endpoints 5
- Adverse Events
- Objective Response Rate (ORR)
- Duration of Response (DOR)
- Patient Reported Outcomes (PROs)
- Quality of Life Assessment
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 6
PRD8665001 · Product
- Active substance
- Adagrasib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 1200 mg milligram(s)
- Max total dose
- 1710000 mg milligram(s)
- Max treatment duration
- 48 Month(s)
- Authorisation status
- Not Authorised
- ATC code
- NOTASSIGN — -
- MA holder
- MIRATI THERAPEUTICS INC
- Paediatric formulation
- No
- Orphan designation
- No
Erbitux 5 mg/mL solution for infusion
PRD327543 · Product
- Active substance
- Cetuximab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 500 mg/m2 milligram(s)/sq. meter
- Max total dose
- 48000 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 48 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FE01 — -
- Marketing authorisation
- EU/1/04/281/005
- MA holder
- MERCK EUROPE B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Erbitux 5 mg/mL solution for infusion
PRD327539 · Product
- Active substance
- Cetuximab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 500 mg/m2 milligram(s)/sq. meter
- Max total dose
- 48000 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 48 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FE01 — -
- Marketing authorisation
- EU/1/04/281/003
- MA holder
- MERCK EUROPE B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB16402MIG · Substance
- Active substance
- Bevacizumab
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 5 mg/kg milligram(s)/kilogram
- Max total dose
- 480 mg/kg milligram(s)/kilogram
- Max treatment duration
- 48 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB26987 · Substance
- Active substance
- Aflibercept
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 4 mg/ml milligram(s)/millilitre
- Max total dose
- 384 mg/ml milligram(s)/millilitre
- Max treatment duration
- 48 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB32795 · Substance
- Active substance
- Ramucirumab
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 8 mg/ml milligram(s)/millilitre
- Max total dose
- 769 mg/ml milligram(s)/millilitre
- Max treatment duration
- 48 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 4
SUB07721MIG · Substance
- Active substance
- Fluorouracil
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 2800 mg/m2 milligram(s)/sq. meter
- Max total dose
- 268800 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 48 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB09490MIG · Substance
- Active substance
- Oxaliplatin
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 85 mg/ml milligram(s)/millilitre
- Max total dose
- 8160 mg/ml milligram(s)/millilitre
- Max treatment duration
- 48 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB08295MIG · Substance
- Active substance
- Irinotecan
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 180 mg/m2 milligram(s)/sq. meter
- Max total dose
- 17280 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 48 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06052MIG · Substance
- Active substance
- Calcium Folinate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 400 mg/m2 milligram(s)/sq. meter
- Max total dose
- 38400 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 48 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Mirati Therapeutics Inc.
- Sponsor organisation
- Mirati Therapeutics Inc.
- Address
- Route 206, Province Line Road Province Line Road
- City
- Princeton
- Postcode
- 08543
- Country
- United States
Scientific contact point
- Organisation
- Mirati Therapeutics Inc.
- Contact name
- Mirati Study Locator
Public contact point
- Organisation
- Mirati Therapeutics Inc.
- Contact name
- Mirati Study Locator
Third parties 9
| Organisation | City, country | Duties |
|---|---|---|
| Accenture Solutions Private Limited ORG-100032592
|
Bangaluru, India | Other |
| Accenture Solutions Private Limited ORG-100032592
|
Chennai, India | Data management |
| Resolution Bioscience Inc. ORG-100048922
|
Kirkland, United States | Other |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | On site monitoring, Code 10, Code 12, Code 2, Code 5 |
| Endpoint Clinical Inc. ORG-100040567
|
Wakefield, United States | Interactive response technologies (IRT) |
| Labcorp Central Laboratory Services S.a.r.l. ORG-100011524
|
Meyrin, Switzerland | Other, Laboratory analysis |
| PRA Hellas CRO A.E. ORG-100048208
|
Nea Ionia, Greece | Other |
| Veristat LLC ORG-100032404
|
Southborough, United States | Other |
| Accenture Solutions Private Limited ORG-100032592
|
Bangaluru, India | Other, Data management |
Locations
15 EU/EEA countries · 76 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ended | 20 | 2 |
| Belgium | Ended | 2 | 2 |
| Czechia | Ended | 7 | 2 |
| Denmark | Ongoing, recruitment ended | 6 | 3 |
| Finland | Ongoing, recruitment ended | 2 | 2 |
| France | Ongoing, recruitment ended | 27 | 13 |
| Germany | Ongoing, recruitment ended | 8 | 12 |
| Greece | Ongoing, recruitment ended | 17 | 4 |
| Ireland | Ended | 3 | 2 |
| Italy | Ongoing, recruitment ended | 27 | 9 |
| Netherlands | Ended | 4 | 4 |
| Poland | Ended | 6 | 4 |
| Portugal | Ended | 4 | 2 |
| Romania | Ended | 29 | 3 |
| Spain | Ongoing, recruitment ended | 37 | 12 |
| Rest of world
Hong Kong, Singapore, Korea, Republic of, Malaysia, Taiwan, Brazil, Canada, Mexico, Argentina, United States, Thailand, United Kingdom, China, Puerto Rico, Colombia, Australia
|
— | 378 | — |
Investigational sites
Noe LGA Gesundheit Thermenregion GmbH
Wiener Neustadt State Hospital, Department of Internal Medicine, Hematology and Internal Oncology, Corvinusring 3-5, 2700, Wiener Neustadt
Medical University of Vienna
AKH Vienna, University Clinic for Internal Medicine I, Clinical Department of Oncology, Waehringer Guertel 18-20, Alsergrund, Vienna
UCL Mont-Godinne
Oncology, Avenue Dr-Gaston-Therasse 1, 5530, Yvoir
UZ Brussel
Medical Oncology, Laarbeeklaan 101, 1090, Jette
Fakultni Nemocnice V Motole
Onkologická klinika 2. LF UK a FN Motol, V Uvalu 84/1, Motol, Prague 5
Masarykuv Onkologicky Ustav
Klinika komplexní onkologické péče, Zluty Kopec 543/7, Stare Brno, Brno-Stred
Odense University Hospital
Department of Oncology, J B Winsloews Vej 4, 5000, Odense C
Rigshospitalet
Department of Oncology, Blegdamsvej 9, 2100, Copenhagen Oe
Lillebaelt Hospital
Department of Oncology, Beriderbakken 4, 7100, Vejle
Tampere University Hospital
Department of Oncology, Teiskontie 35, 33520, Tampere
Turku University Hospital
Department of Oncology, Kiinamyllynkatu 4-8, 20520, Turku
Institut Gustave Roussy
Service d’oncologie digestive, 114 Rue Edouard Vaillant, 94800, Villejuif
Centr Georges Francois Leclerc
UF Oncologie, 1 Rue Professeur Marion, 21000, Dijon
University Hospitals Pitie Salpetriere Charles Foix
Service d’Hépato-Gastro-Entérologie, 47 To 83 Boulevard De L Hopital, 75013, Paris
Centre Hospitalier Universitaire De Toulouse
Unité de Recherche Clinique (Oncologie Médicale Digestive), 2 Rue Viguerie, Tsa 80035, Toulouse Cedex 9
Hôpital de la Timone
Service Hépato-Gastro-Entérologie et Oncologie Digestive, 265 Rue Saint Pierre, 13005, Marseille Cedex 5
Hospital Foch
Service d’Oncologie Médicale, 40 Rue Worth, 92150, Suresnes
Centre Hospitalier Universitaire De Bordeaux
Service d’hepatogastro-enterologie et oncologie digestive, Avenue De Magellan, 33600, Pessac
Centre Hospitalier Universitaire De Lille
Service d’Oncologie Médicale, Rue Michel Polonovski, 59037, Lille Cedex
Assistance Publique Hopitaux De Paris
Service d’oncologie digestive, 20 Rue Leblanc, 75015, Paris
Besancon University Hospital Center
Service Oncologie Médicale, 2 Place Saint Jacques, Cs 51804, Besancon Cedex
Institut Bergonie
Unité de Recherche et d’Epidémiologie Clinique, 229 Cours De L Argonne, 33000, Bordeaux
Centre Hospitalier Regional Universitaire De Tours
Service d’Hépato-gastroentérologie et Cancérologie Digestive, 2 Boulevard Tonnelle, 37044, Tours Cedex 9
Hopital Saint Antoine
Service d’oncologie medicale, 184 Rue Du Faubourg Saint Antoine, 75571, Paris Cedex 12
Kreiskliniken Reutlingen GmbH
Kreiskliniken Reutlingen - Klinikum am Steinenberg, Steinenbergstrasse 31, Ringelbach, Reutlingen
Muenchen Klinik gGmbH
München Klinik Neuperlach, Klinik für Hämatologie und Onkologie, Oskar-Maria-Graf-Ring 51, Ramersdorf-Perlach, Munich
Klinikum der Universitaet Muenchen AöR
LMU Klinikum - Campus Großhadern, Medizinische Klinik und Poliklinik II, Marchioninistrasse 15, Hadern, Munich
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Universitatsklinikum Carl Gustav Carus Dresden, Medizinische Klinik und Poliklinik I, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Charite Universitaetsmedizin Berlin KöR
Charité Campus Mitte Medizinische Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunologie, Chariteplatz 1, Mitte, Berlin
Klinikum St Marien Amberg
Klinikum St. Marien Amberg, Mariahilfbergweg 7, Mariahilfbergweg 7, 92224, Amberg
Haematologisch Onkologische Praxis Eppendorf
Facharztzentrum Eppendorf, Eppendorfer Landstrasse 42, 20249, Hamburg
St. Josef-Hospital
Medizinische Universitätsklinik Ruhr- Hämatologie, Onkologie und Palliativmedizin, Gudrunstrasse 56, Grumme, Bochum
Marien Hospital Herne Universitatsklinikum Der Ruhr-Universitat Bochum
Marien Hospital Herne - Universitätsklinikum der Ruhr, Medizinische Klinik lll Hämatologie/Onkologie, Hoelkeskampring 40, 44625, Herne
Kliniken Maria Hilf GmbH Moenchengladbach
Kliniken Maria Hilf GmBH, Klinik für Hämatologie, Onkologie und Gastroenterologie, Viersener Strasse 450, Windberg, Moenchengladbach
Institut fuer Klinische Krebsforschung IKF GmbH
Krankenhaus Nordwest, Steinbacher Hohl 2-26, Steinbacher Hohl 2-26, Praunheim, Frankfurt Am Main
Universitaetsklinikum Ulm AöR
Universitätsklinikum Ulm, Klinik für Innere Medizin I, Albert-Einstein-Allee 23, Eselsberg, Ulm
General University Hospital Of Larissa
Oncology Clinic - 1st Internal Medicine Division, P. O. Box 1425, 411 10, Larissa
Metropolitan General Hospital Healthcare Facilities Operation And Management Single Member S.A.
Oncologic Clinical Trials and Research Clinic, Leoforos Mesogeion 264, 155 62, Cholargos
Alexandra Hospital
Clinical Therapeutics Department, Oncology Unit, Vassilissas Sofias Avenue 80, 115 28, Athens
Euromedica General Clinic Of Thessaloniki
2nd Medical Oncology Department, Kallas Marias 11, Gravias 2, Thessaloniki
Tallaght University Hospital
Oncology Day Unit, Tallaght, D24 NR0A, Dublin 24
St Vincent's University Hospital
Medical Oncology Research Department, Elm Park Merrion Road, D04 T6F4, Dublin 4
European Institute Of Oncology S.r.l.
Oncologia Medica Gastrointestinale e Tumori Neuroendocrini, Via Giuseppe Ripamonti 435, 20141, Milan
I.F.O. Istituti Fisioterapici Ospitalieri
UO Oncologia Medica 2, Via Elio Chianesi N 53, 00144, Rome
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS
UO Oncologia Medica, Strada Provinciale 142 Km 3,95, 10060, Candiolo
Azienda USL IRCCS Di Reggio Emilia
S.C. Oncologia, Viale Risorgimento 80, 42123, Reggio Emilia
Azienda Sanitaria Locale Della Provincia Di Biella
SOC Oncologia, Via Dei Ponderanesi 2, 13875, Ponderano
AORN San Giuseppe Moscati Avellino
U.O.C. Oncologia, Contrada Amoretta, 83100, Avellino
Azienda Ospedaliera Universitaria Di Cagliari
UOC Oncologia Medica, Strada Statale 554 N. 1, 09042, Monserrato
Istituto Oncologico Veneto
UOC Oncologia 3, Via Gattamelata 64, 35128, Padova
Azienda Ospedaliero Universitaria Pisana
U.O. Oncologia Medica 2, Via Roma 67, 56126, Pisa
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Department of gastrointestinal and liver oncology (MDL), Plesmanlaan 121, 1066 CX, Amsterdam
St. Antonius Ziekenhuis
Department of Oncology, Koekoekslaan 1, 3435 CM, Nieuwegein
Amsterdam UMC
Department of Oncology, De Boelelaan 1117, 1081 HV, Amsterdam
Stichting Radboud University Medical Center
Department of Oncology, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Europejskie Centrum Zdrowia Otwock Sp. z o.o.
Oncology, Ul. Borowa 14/18, 05-400, Otwock
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
Oncology, Ul. Woloska 137, 02-507, Warsaw
Copernicus Podmiot Leczniczy Sp. z o.o.
Oncology, Al. Zwyciestwa 31/32, 80-219, Gdansk
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Oncology, Ul. Wawelska 15, 02-034, Warsaw
Unidade Local De Saude De Santa Maria E.P.E.
Medical Oncology, Avenida Professor Egas Moniz, 1649-035, Lisbon
Champalimaud Clinical Centre
Oncology, Avenida Brasilia S/n, 1400-038, Lisbon
Centrul De Oncologie SF Nectarie S.R.L.
Medical Oncology, Strada Caracal Nr 109, 200542, Craiova
Spitalul Judetean De Urgenta Dr. Constantin Opris Baia Mare
Medical Oncology, Strada Cosbuc George Nr 31, 430031, Baia Mare
Institutul Clinic Fundeni
Medical Oncology, Soseaua Fundeni 258, 022328, Bucharest
Hospital Clinico Universitario De Valencia
Oncology Department, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital General Universitario De Valencia
Oncology Department, Avenida Del Tres Cruces 2, 46014, Valencia
Hospital Universitario 12 De Octubre
Oncology Department, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Clinic De Barcelona
Oncology Department, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario Marques De Valdecilla
Oncology Department, Avenida Valdecilla Sn, 39008, Santander
Fir Huvh Fundacio Institut De Recerca Hospital Universitari Vall De Hebron
Oncology Department, Passeig De La Vall D'hebron 119-129, 08035, Barcelona
Hospital Universitario Reina Sofia
Oncology Department, Avenida Menendez Pidal S/n, 14004, Cordoba
Hospital General Universitario Gregorio Maranon
Oncology Department, Calle Del Doctor Esquerdo 46, 28009, Madrid
Institut Catala D'oncologia
Oncology Department, Carretera Canyet S/n, 08916, Badalona
Institut Catala D'oncologia
Oncology Department, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Clinico San Carlos
Oncology Department, Calle Del Profesor Martin Lagos Sn, 28040, Madrid
Hospital Universitario La Paz
Oncology Department, Paseo Castellana 261, 28046, Madrid
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2022-02-07 | 2024-09-27 | 2022-09-21 | 2023-10-03 | |
| Belgium | 2022-03-14 | 2024-04-09 | 2022-09-09 | 2022-09-30 | |
| Czechia | 2022-03-08 | 2025-11-03 | 2022-09-01 | 2023-10-24 | |
| Denmark | 2022-05-25 | 2022-06-20 | 2023-07-24 | ||
| Finland | 2022-05-20 | 2023-02-13 | 2023-08-28 | ||
| France | 2022-03-30 | 2022-05-13 | 2023-10-04 | ||
| Germany | 2022-06-24 | 2022-10-13 | 2023-07-20 | ||
| Greece | 2021-11-30 | 2022-01-12 | 2023-09-27 | ||
| Ireland | 2022-08-26 | 2025-01-02 | 2022-09-14 | 2023-06-28 | |
| Italy | 2022-02-16 | 2022-03-18 | 2023-09-29 | ||
| Netherlands | 2022-06-23 | 2025-04-17 | 2022-12-30 | 2023-09-05 | |
| Poland | 2021-12-09 | 2024-08-13 | 2022-02-03 | 2023-01-23 | |
| Portugal | 2022-02-25 | 2026-05-06 | 2023-02-09 | 2023-09-27 | |
| Romania | 2023-02-28 | 2025-10-24 | 2023-03-29 | 2023-09-04 | |
| Spain | 2021-12-17 | 2022-01-28 | 2023-10-04 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Corrective measures 9 · Art. 77 CTR
Corrective measure CM-BE-0001
- Member state
- Belgium
- Publication date
- 2024-02-21
- Type
- 3
- Reason
- 5
- Immediate action required
- Yes
- Justification
- See the attached document
Corrective measure CM-ES-0004
- Member state
- Spain
- Publication date
- 2024-02-12
- Type
- 3
- Reason
- 5
- Immediate action required
- Yes
Corrective measure CM-FI-0001
- Member state
- Finland
- Publication date
- 2024-04-05
- Type
- 4
- Reason
- 5
- Immediate action required
- No
- Justification
- With a reference to Article 77 of the Clinical Trials Regulation, before a
decision is made of whether any corrective measures related to the
matter should be implemented in Finland, the sponsor is
provided with an opportunity to give a statement on the matter and to express its opinion on the measures proposed in the safety roundtable
meeting on 6th February 2024.
Corrective measure CM-FR-0001
- Member state
- France
- Publication date
- 2024-03-06
- Type
- 3
- Reason
- 5
- Immediate action required
- Yes
Corrective measure CM-GR-0001
- Member state
- Greece
- Publication date
- 2024-02-23
- Type
- 3
- Reason
- 5
- Immediate action required
- Yes
- Justification
- See attached document
Corrective measure CM-IE-0001
- Member state
- Ireland
- Publication date
- 2024-02-26
- Type
- 3
- Reason
- 5
- Immediate action required
- No
- Justification
- See attached Document
Corrective measure CM-NL-0002
- Member state
- Netherlands
- Publication date
- 2024-02-19
- Type
- 3
- Reason
- 5
- Immediate action required
- No
- Justification
- See the attached document
Corrective measure CM-NL-0003
- Member state
- Netherlands
- Publication date
- 2024-02-15
- Type
- 3
- Reason
- 5
- Immediate action required
- Yes
- Justification
- This corrective measure is by accident submitted two times. Please check CM-NL-0002 and ignore this one
Corrective measure CM-PT-0003
- Member state
- Portugal
- Publication date
- 2024-02-19
- Type
- 3
- Reason
- 5
- Immediate action required
- Yes
- Justification
- see attatched document
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 177 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol Admin letter_2023-506241-30-00_redacted | N/A |
| Protocol (for publication) | D1_Protocol_2023-506241-30-00_Greek_redacted | 5.4 |
| Protocol (for publication) | D1_Protocol_2023-506241-30-00_redacted | 5.4 |
| Protocol (for publication) | D4_EN_Patient Facing Document_EQ-5D-5L | N/A |
| Protocol (for publication) | D4_EN_Patient Facing Document_QLQ-C30 | N/A |
| Recruitment arrangements (for publication) | K_AT_Recruitment Arrangements_Placeholder document | 1 |
| 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_DE_Recruitment Arrangements_Placeholder document | 1 |
| Recruitment arrangements (for publication) | K_DK_Recruitment Arrangement_Placeholder Document | 1 |
| Recruitment arrangements (for publication) | K_EL_Recruitment Arrangements_Placeholder document | 1 |
| Recruitment arrangements (for publication) | K_ES_Recruitment Arrangement_Placeholder document | 1 |
| Recruitment arrangements (for publication) | K_FI_Recruitment Arrangements_Placeholder Document | 1 |
| Recruitment arrangements (for publication) | K_FR_Recruitment Arrangements_Placeholder document | 1 |
| Recruitment arrangements (for publication) | K_IE_Recruitment Arrangement_Placeholder document | 1 |
| Recruitment arrangements (for publication) | K_IT_Recruitment Arrangement_Placeholder document | 1 |
| Recruitment arrangements (for publication) | K_NL_Recruitment Arrangements_Placeholder document | 1 |
| Recruitment arrangements (for publication) | K_PL_Recruitment Arrangement_Placeholder document | 1 |
| Recruitment arrangements (for publication) | K_PT_Recruitment Arrangements_Placeholder document | 1 |
| Recruitment arrangements (for publication) | K_RO_Recruitment Arrangement_Placeholder document | 1 |
| Subject information and informed consent form (for publication) | L1_AT_SIS-ICF_Addendum_German | 1.0 |
| Subject information and informed consent form (for publication) | L1_AT_SIS-ICF_Main_German_redacted | 7.1 |
| Subject information and informed consent form (for publication) | L1_AT_SIS-ICF_Post Disease Progression_German | 4.0 |
| Subject information and informed consent form (for publication) | L1_AT_SIS-ICF_Pre-screening_German_redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_AT_SIS-ICF_pregnancy participant_German_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_AT_SIS-ICF_Pregnant Partner_German_redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_AT_SIS-ICF_Site Info_German_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Continuation Post Dis Progr ICF | 4.0 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Continuation Post Dis Progr ICF_Dutch | 4.1 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Continuation Post Dis Progr ICF_French | 4.1 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_ICF Addendum_Dutch | 1.0 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_ICF Addendum_French | 1.0 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Main ICF | 6.0 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Main ICF_Dutch_redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Main ICF_French_redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Pre-Screening ICF | 4.1 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Pre-Screening ICF_Dutch_redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Pre-Screening ICF_French_redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Pregnancy ICF | 4.0 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Pregnancy_Dutch | 5.0 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Pregnancy_French | 5.0 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Pregnant Partner ICF | 4.1 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Pregnant Partner_Dutch | 5.0 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Pregnant Partner_French | 5.0 |
| Subject information and informed consent form (for publication) | L1_CZ_SIS-ICF_Continuation Post Disease Progression_Czech_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_CZ_SIS-ICF_GDPR_Czech_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_CZ_SIS-ICF_Main ICF Addendum_Czech | 1.0 |
| Subject information and informed consent form (for publication) | L1_CZ_SIS-ICF_Main_Czech_redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_CZ_SIS-ICF_Optional Exploratory Research_Czech_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_CZ_SIS-ICF_Optional Genetic Research_Czech_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_CZ_SIS-ICF_Pre-Screening_Czech_redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_CZ_SIS-ICF_Pregnancy FU_Czech_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_CZ_SIS-ICF_Pregnant Partner_Czech_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_DE_SIS-ICF_Addendum_German | 1.0 |
| Subject information and informed consent form (for publication) | L1_DE_SIS-ICF_Main_German_redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_DE_SIS-ICF_Post Disease Progression_German | 2.1 |
| Subject information and informed consent form (for publication) | L1_DE_SIS-ICF_pre-screening_German_redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_DE_SIS-ICF_pregnancy_German_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_DE_SIS-ICF_pregnant partner_German_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_DK_SIS-ICF_Continuation_Danish | 2.0 |
| Subject information and informed consent form (for publication) | L1_DK_SIS-ICF_Main_Danish_redacted | 5.1 |
| Subject information and informed consent form (for publication) | L1_DK_SIS-ICF_Pre-Screening_Danish_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_EL_SIS-ICF_Continuation Post Progression | 3.0 |
| Subject information and informed consent form (for publication) | L1_EL_SIS-ICF_Continuation Post Progression_Greek | 3.0 |
| Subject information and informed consent form (for publication) | L1_EL_SIS-ICF_Main Addendum | 1.0 |
| Subject information and informed consent form (for publication) | L1_EL_SIS-ICF_Main Addendum_Greek | 1.0 |
| Subject information and informed consent form (for publication) | L1_EL_SIS-ICF_Main_Greek_redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_EL_SIS-ICF_Main_redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_EL_SIS-ICF_Pre-Screening_Greek_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_EL_SIS-ICF_Pre-Screening_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_EL_SIS-ICF_Pregnancy | 2.0 |
| Subject information and informed consent form (for publication) | L1_EL_SIS-ICF_Pregnancy_Greek | 2.0 |
| Subject information and informed consent form (for publication) | L1_EL_SIS-ICF_Pregnant Partner_Greek_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_EL_SIS-ICF_Pregnant Partner_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_EL_SIS-ICF_SCOUT_Greek_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_EL_SIS-ICF_SCOUT_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ES_SIS-ICF_Continuation Post Disease Progression_Spanish | 3.0 |
| Subject information and informed consent form (for publication) | L1_ES_SIS-ICF_Data Protection_Spanish_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_ES_SIS-ICF_ICF Addendum_Spanish | 1.0 |
| Subject information and informed consent form (for publication) | L1_ES_SIS-ICF_Main_Spanish_redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_ES_SIS-ICF_Pre-Screening_Spanish_redacted | 3.1 |
| Subject information and informed consent form (for publication) | L1_ES_SIS-ICF_Pregnancy_Spanish_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_ES_SIS-ICF_Pregnant Partner_Spanish_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_ES_SIS-ICF_Scout_Spanish | 1.0 |
| Subject information and informed consent form (for publication) | L1_FI_SIS-ICF Addendum_Finnish | 1.0 |
| Subject information and informed consent form (for publication) | L1_FI_SIS-ICF_Continuation_Finnish | 2.0 |
| Subject information and informed consent form (for publication) | L1_FI_SIS-ICF_Continuation_Swedish | 2.0 |
| Subject information and informed consent form (for publication) | L1_FI_SIS-ICF_Main_Finnish_redacted | 5.1 |
| Subject information and informed consent form (for publication) | L1_FI_SIS-ICF_Main_Swedish_redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_FI_SIS-ICF_Pre-Screening_Finnish_redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_FI_SIS-ICF_Pre-Screening_Swedish_redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_FI_SIS-ICF_Pregnancy_Finnish_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_FI_SIS-ICF_Pregnancy_Swedish_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_FI_SIS-ICF_Voluntary_Finnish_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_FI_SIS-ICF_Voluntary_Swedish_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_FR_SIS-ICF_Continuation_Post Disease Progression_French | 3.0 |
| Subject information and informed consent form (for publication) | L1_FR_SIS-ICF_Main ICF Addendum_French | 1.2 |
| Subject information and informed consent form (for publication) | L1_FR_SIS-ICF_Main_French_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_FR_SIS-ICF_Patient Pregnancy_French | 2.0 |
| Subject information and informed consent form (for publication) | L1_FR_SIS-ICF_Pregnant Partner_French_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_FR_SIS-ICF_Prescreening_French_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_FR_SIS-ICF_Scout_French | 1.1 |
| Subject information and informed consent form (for publication) | L1_IE_SIS-ICF_Main Addendum | 1.0 |
| Subject information and informed consent form (for publication) | L1_IE_SIS-ICF_Main_redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_IE_SIS-ICF_Post Disease Progression_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_IE_SIS-ICF_Pre-Screening_redacted | 3.1 |
| Subject information and informed consent form (for publication) | L1_IE_SIS-ICF_Pregnancy_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_IE_SIS-ICF_Pregnant Partner_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_IT_CEC approval_Italian_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_IT_SIS-ICF_Addendum_Italian | 1.0 |
| Subject information and informed consent form (for publication) | L1_IT_SIS-ICF_Adult_Italian_redacted | 7.1 |
| Subject information and informed consent form (for publication) | L1_IT_SIS-ICF_Continuation_Italian_redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_IT_SIS-ICF_Partner Pregnancy Follow Up_Italian_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_IT_SIS-ICF_Pregnancy Follow Up_Italian_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_IT_SIS-ICF_Prescreening_Italian_redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_IT_SIS-ICF_Privacy_Italian_redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_NL_SIS-ICF_Continuation Post Disease Progression_Dutch_redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_NL_SIS-ICF_ICF Addendum_Dutch | 1.0 |
| Subject information and informed consent form (for publication) | L1_NL_SIS-ICF_Main_Dutch_redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_NL_SIS-ICF_Pre-Screening_Dutch_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_NL_SIS-ICF_Pregnancy_Dutch_redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_NL_SIS-ICF_Pregnant Partner_Dutch_redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_PL_SIS-ICF_Addendum_Polish | 1.0 |
| Subject information and informed consent form (for publication) | L1_PL_SIS-ICF_Continuation_Post Disease Progression_Polish | 3.0 |
| Subject information and informed consent form (for publication) | L1_PL_SIS-ICF_Main_Polish_redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_PL_SIS-ICF_Optional Future Research_Polish | 2.0 |
| Subject information and informed consent form (for publication) | L1_PL_SIS-ICF_Pre-Screening_Polish_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_PL_SIS-ICF_Pregnancy_Polish | 2.0 |
| Subject information and informed consent form (for publication) | L1_PL_SIS-ICF_Pregnant Partner_Polish_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_PL_SIS-ICF_Scout_Polish | 1.0 |
| Subject information and informed consent form (for publication) | L1_PT_SIS-ICF_Continuation-Post Disease Progression_Portuguese | 2.0 |
| Subject information and informed consent form (for publication) | L1_PT_SIS-ICF_Main Addendum_Portuguese | 1.1 |
| Subject information and informed consent form (for publication) | L1_PT_SIS-ICF_Main_Portuguese_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_PT_SIS-ICF_Pregnancy_Portuguese | 3.0 |
| Subject information and informed consent form (for publication) | L1_PT_SIS-ICF_Pregnant Partner_Portuguese_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_PT_SIS-ICF_Prescreening_Portuguese_redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_RO_SIS-ICF_Continuation ICF_Post Disease Progression_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_RO_SIS-ICF_Continuation ICF_Post Disease Progression_Romanian_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_RO_SIS-ICF_Main ICF Addendum | 1.0 |
| Subject information and informed consent form (for publication) | L1_RO_SIS-ICF_Main ICF Addendum_Romanian | 1.0 |
| Subject information and informed consent form (for publication) | L1_RO_SIS-ICF_Main_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_RO_SIS-ICF_Main_Romanian_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_RO_SIS-ICF_Personal data processing for travel reimbursement | 1.0 |
| Subject information and informed consent form (for publication) | L1_RO_SIS-ICF_Personal data processing for travel reimbursement_Romanian | 1.0 |
| Subject information and informed consent form (for publication) | L1_RO_SIS-ICF_Pre-Screening_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_RO_SIS-ICF_Pre-Screening_Romanian_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_RO_SIS-ICF_Pregnancy_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_RO_SIS-ICF_Pregnancy_Romanian_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_RO_SIS-ICF_Pregnant Partner_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_RO_SIS-ICF_Pregnant Partner_Romanian_Redacted | 3.0 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Bevacizumab | 67 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Calcium Folinate | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Calcium Folinate_Hikma | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Calcium Folinate_STADApharm | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Erbitux_Merck | 35 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Fluorouracil_Hospira | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Fluorouracil_Medac Gesellschaft | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Irinotecan_Accord | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Irinotecan_Aqvida | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Irinotecan_FreseniusKabi | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Irinotecan_HauptPharma | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Oxaliplatin | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Oxaliplatin_FreseniusKabi | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Oxaliplatin_STADApharm | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Ramucirumab | 22 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_ZIV aflibercept | N/A |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-506241-30-00 | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-506241-30-00_Czech | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-506241-30-00_Dutch | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-506241-30-00_French | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-506241-30-00_German | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-506241-30-00_Greek | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-506241-30-00_Italian | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-506241-30-00_Polish | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-506241-30-00_Portuguese | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-506241-30-00_Romanian | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-506241-30-00_Spanish | 1.0 |
Application history
22 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-26 | Spain | Acceptable 2023-12-11
|
2023-12-11 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-03-11 | Acceptable | 2024-04-29 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-03-11 | Acceptable | 2024-05-27 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-03-11 | Acceptable | 2024-04-29 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-03-11 | Acceptable | 2024-05-02 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-03-11 | Acceptable | 2024-04-04 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-03-11 | Acceptable | 2024-05-24 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-03-11 | Acceptable | 2024-05-17 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-8 | 2024-03-11 | Acceptable | 2024-06-21 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-9 | 2024-03-11 | Acceptable | 2024-04-15 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-10 | 2024-03-11 | Acceptable | 2024-04-22 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-11 | 2024-03-11 | Acceptable | 2024-04-25 | |
| 13 | SUBSTANTIAL MODIFICATION | SM-12 | 2024-03-11 | Acceptable | 2024-04-22 | |
| 14 | SUBSTANTIAL MODIFICATION | SM-13 | 2024-03-11 | Acceptable | 2024-05-15 | |
| 15 | SUBSTANTIAL MODIFICATION | SM-14 | 2024-03-11 | Acceptable | 2024-04-25 | |
| 16 | SUBSTANTIAL MODIFICATION | SM-16 | 2024-04-15 | Spain | Acceptable | 2024-04-16 |
| 17 | SUBSTANTIAL MODIFICATION | SM-17 | 2024-10-07 | Spain | Acceptable 2025-01-27
|
2025-01-27 |
| 18 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-03-14 | Spain | Acceptable 2025-01-27
|
2025-03-14 |
| 19 | SUBSTANTIAL MODIFICATION | SM-19 | 2025-07-01 | Spain | Acceptable 2025-09-18
|
2025-09-18 |
| 20 | SUBSTANTIAL MODIFICATION | SM-32 | 2025-11-19 | Acceptable | 2026-01-23 | |
| 21 | SUBSTANTIAL MODIFICATION | SM-34 | 2026-03-09 | Spain | Acceptable 2026-05-06
|
2026-05-06 |
| 22 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-05-14 | Spain | Acceptable 2026-05-06
|
2026-05-14 |