Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
441
Countries
18
Sites
151
Colorectal Cancer (CRC)
To compare progression free survival (PFS) in treatment-naïve subjects with KRAS p.G12C mutated metastaticcolorectal cancer (mCRC) between the experimental arm and the control arm
Key facts
- Sponsor
- Amgen Inc.
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 10 Feb 2025 → ongoing
- Decision date (initial)
- 2024-08-05
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Amgen Inc.
External identifiers
- EU CT number
- 2022-502352-31-00
- WHO UTN
- U1111-1300-2581
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Pharmacokinetic, Safety
To compare progression free survival (PFS) in treatment-naïve subjects with KRAS p.G12C mutated metastaticcolorectal cancer (mCRC) between the experimental arm and the control arm
Secondary objectives 5
- To compare overall survival (OS) between the experimental arm and the control arm
- To evaluate other measures of efficacy of the experimental arm vs the control arm
- To evaluate the safety and tolerability of the experimental arm vs the control arm
- To characterize the pharmacokinetics (PK) of sotorasib
- To compare the objective response rate (ORR) between the experimental arm and the control arm
Conditions and MedDRA coding
Colorectal Cancer (CRC)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10052362 | Metastatic colorectal cancer | 10029104 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Randomised active-controlled study Treatment phase This phase 3, multicenter, randomized, open-label, active-controlled study will
evaluate efficacy and safety of the experimental arm and the control arm in treatment-naïve -subjects with mCRC with KRAS p.G12C mutation.
|
Randomised Controlled | None | Experimental arm: Subjects in the experimental arm will receive sotorasib in combination with panitumumab and FOLFIRI. Control arm: Subjects randomized to the control arm will receive FOLFIRI with or without bevacizumab-awwb. |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- Yes
- IPD plan description
- De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request. Information on IPD sharing Access Criteria, Time Frame and Supporting Information Type is available at ClinicalTrials.gov (https://clinicaltrials.gov/study/NCT06252649) and at Amgen Clinical Trials portal (http://www.amgen.com/datasharing).
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 9
- Pathologically documented metastatic colorectal adenocarcinoma
- Central confirmation of KRAS p.G12C mutation
- Measurable disease per RECIST v1.1 criteria. Lesions previously radiated are not considered measurable unless they have progressed after radiation
- Age ≥ 18 years (or ≥ legal age within the country if it is more than 18 years)
- Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1
- Life expectancy of > 6 months, in the opinion of the investigator
- Adequate hematologic and end organ function
- Ability to take oral medications and willing to record daily adherence to investigational product
- Central laboratory detection of KRAS p.G12C mutation
Exclusion criteria 5
- Active, untreated brain metastases
- Leptomeningeal disease
- Previous treatment with a KRAS p.G12C inhibitor
- Subject has required a dose reduction or dose delay of either 5-fluorouracil (5-FU) or irinotecan in any prior chemotherapy regimen in the past for toxicity, to the investigator's knowledge
- History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline CT scan
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- PFS, defined as time from randomization until disease progression or death from any cause, whichever occurs first. Progression will be based on blinded independent central review (BICR) of disease response per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
Secondary endpoints 10
- OS, defined as time from randomization until death from any cause
- Objective response rate (ORR), defined as proportion of complete response (CR) + partial response (PR), assessed per RECIST v1.1 by BICR. CR and PR require confirmatory repeat assessment at least 4 weeks after the first detection of response.
- Duration of response (DOR) per RECIST v1.1 by BICR, defined as the time from the first documentation of objective response until the first documentation of disease progression or death from any cause, whichever occurs first.
- Disease control rate (DCR), defined as proportion of CR + PR + stable disease (SD) per RECIST v1.1 by BICR. Minimum time interval for determination of SD is 7 weeks from randomization date
- Time to response (TTR), defined as the time from randomization to first documentation of objective response per RECIST v1.1 by BICR.
- Depth of response per RECIST v1.1 by BICR, defined as best percent change from baseline in sum of lesion diameters.
- Early tumor shrinkage (ETS) by BICR, defined as achieving at least 30% reduction in tumor size at first post-baseline assessment (at least 7 weeks from randomization date).
- PFS, ORR, DOR, DCR, TTR, depth of response and ETS based on investigator’s assessment per RECIST v1.1, if applicable.
- Incidence and severity of treatment-emergent adverse events, changes in vital signs, and changes in clinical laboratory tests.
- PK parameters of sotorasib including, but not limited to, maximum plasma concentration (Cmax) and pre-dose (Ctrough) concentrations, as applicable.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 5
SUB197397 · Substance
- Active substance
- Sotorasib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 960 mg milligram(s)
- Max total dose
- 467520 mg milligram(s)
- Max treatment duration
- 16 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Please refer to the sotorasib IMPD-Q enclosed with the application.
Irinotecan Hydrochloride Trihydrate
SUB45873 · Substance
- Active substance
- Irinotecan Hydrochloride Trihydrate
- 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
- 6300 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 16 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
- 14000 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 16 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
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
- 98000 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 16 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB25390 · Substance
- Active substance
- Panitumumab
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 6 mg/Kg milligram(s)/kilogram
- Max total dose
- 210 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 16 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 2
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
- 175 mg/kg milligram(s)/kilogram
- Max treatment duration
- 16 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- 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
- 175 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 16 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
Amgen Inc.
- Sponsor organisation
- Amgen Inc.
- Address
- 1 Amgen Center Drive
- City
- Thousand Oaks
- Postcode
- 91320-1799
- Country
- United States
Scientific contact point
- Organisation
- Amgen Inc.
- Contact name
- Medical Information
Public contact point
- Organisation
- Amgen Inc.
- Contact name
- Medical Information
Third parties 16
| Organisation | City, country | Duties |
|---|---|---|
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | E-data capture |
| Azenta US Inc. ORG-100012907
|
Indianapolis, United States | Other |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Laboratory analysis |
| Reify Health Inc. ORG-100049669
|
Boston, United States | Other |
| Excelya Greece CRO Single Member S.A. ORG-100009224
|
Nea Filadelfia, Greece | On site monitoring, Code 12 |
| Altasciences Compagnie Inc. ORG-100037610
|
Laval, Canada | Other |
| Suvoda LLC ORG-100043523
|
Conshohocken, United States | Interactive response technologies (IRT) |
| WCG Clinical Inc. ORG-100040730
|
Princeton, United States | Code 10, Other |
| Tempus AI Inc. ORG-100044006
|
Chicago, United States | Other |
| Tempus AI Inc. ORG-100044006
|
Chicago, United States | Other |
| Altasciences Compagnie Inc. ORG-100037610
|
Laval, Canada | Other |
| Avantor Performance Materials Inc. ORG-100025262
|
Phillipsburg, United States | Other |
| Guardant Health Inc. ORG-100042461
|
Redwood City, United States | Other |
| Voiant LLC ORG-100051555
|
Waltham, United States | Other |
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Laboratory analysis |
| Signant Health Global LLC ORG-100040604
|
Blue Bell, United States | E-data capture |
Locations
18 EU/EEA countries · 151 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruiting | 7 | 5 |
| Belgium | Ongoing, recruiting | 15 | 8 |
| Bulgaria | Ongoing, recruiting | 10 | 5 |
| Czechia | Ongoing, recruiting | 10 | 6 |
| Denmark | Ongoing, recruiting | 4 | 4 |
| Estonia | Ongoing, recruiting | 3 | 1 |
| France | Ongoing, recruiting | 30 | 17 |
| Germany | Ongoing, recruiting | 13 | 10 |
| Greece | Ongoing, recruiting | 15 | 14 |
| Hungary | Ongoing, recruiting | 7 | 7 |
| Italy | Ongoing, recruiting | 48 | 20 |
| Netherlands | Ongoing, recruiting | 11 | 6 |
| Poland | Ongoing, recruiting | 9 | 9 |
| Portugal | Ongoing, recruiting | 14 | 9 |
| Romania | Ongoing, recruiting | 9 | 7 |
| Slovakia | Ongoing, recruiting | 2 | 2 |
| Spain | Ongoing, recruiting | 32 | 20 |
| Sweden | Ongoing, recruiting | 2 | 1 |
| Rest of world
Australia, Switzerland, United Kingdom, Canada, Thailand, Korea, Republic of, Colombia, Turkey, Taiwan, United States, Brazil, Japan, Chile, Hong Kong, Mexico, Argentina
|
— | 200 | — |
Investigational sites
Ordensklinikum Linz GmbH
Department of Internal Medicine I, Fadingerstrasse 1, 4020, Linz
Vorarlberger Krankenhaus-Betriebsgesellschaft mbH
Internal Medicine II, Oncology - Internal E, Carinagasse 47, 6800, Feldkirch
Medical University Of Vienna
Department of Medicine I, Division of Oncology, Waehringer Guertel 18-20, Alsergrund, Vienna
Medical University Of Graz
Clinical Department of Oncology, Neue Stiftingtalstrasse 6, 8010, Graz
Noe LGA Gesundheit Thermenregion GmbH
Internal medicine, hematology and internal oncology, Corvinusring 3-5, 2700, Wiener Neustadt
Vitaz
Gastroenterology, Moerlandstraat 1, 9100, Sint-Niklaas
UZ Leuven
Gastroenterology, Herestraat 49, 3000, Leuven
Universitair Ziekenhuis Gent
Gastroenterology, Corneel Heymanslaan 10, 9000, Gent
Grand Hopital De Charleroi
Gastroenterology, Grand'rue 3, 6000, Charleroi
Institut Jules Bordet
Gastroenterology, Mijlenmeersstraat 90, 1070, Anderlecht
A.Z. Sint-Maarten
Gastroenterology, Liersesteenweg 435, 2800, Mechelen
Cliniques Universitaires Saint-Luc
Gastroenterology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Algemeen Ziekenhuis Delta
Gastroenterology, Deltalaan 1, 8800, Roeselare
Muliprofile Hospital For Active Treatment Central Onco Hospital OOD
Department of Medical Oncology, Bulevard Vasil Aprilov 20, 4002, Plovdiv
Specialized Hospital For Active Treatment Of Oncology Haskovo EOOD
Department of Medical Oncology, Bulevard Siedinenie 49, 6304, Haskovo
Complex Oncological Center Plovdiv EOOD
Department of Medical Oncology and Oncology diseases in Gastroenterology, Bulevard Aleksandir Stamboliyski 2a, 4004, Plovdiv
Multiprofile Hospital For Active Treatment Serdicamed EOOD
Second Department of Medical Oncology, Bulevard Prezident Linkiln 128, 1632, Sofia
Military Medical Academy
Clinic of Medical Oncology, Ulitsa Sveti Georgi Sofiyski 3, 1606, Sofiya
Masarykuv Onkologicky Ustav
Klinika komplexni onkologicke pece, Zluty Kopec 543/7, Stare Brno, Brno-Stred
Fakultni Nemocnice V Motole
Onkologicka klinika, V Uvalu 84/1, Motol, Prague 5
Fakultni Nemocnice Kralovske Vinohrady
Radioterapeuticka a onkologicka klinika, Srobarova 1150/50, Vinohrady, Prague 10
University Hospital Olomouc
Onkologicka klinika, Zdravotniku 248/7, 779 00, Olomouc
Fakultni Nemocnice Hradec Kralove
Klinika onkologie a radioterapie, Sokolska 581, 500 03, Novy Hradec Kralove
Fakultni Nemocnice Bulovka
Ustav radiacni onkologie, Budinova 67/2, Liben, Prague
Aalborg University Hospital
Onkologisk Afdelning, Hobrovej 18-22, 9000, Aalborg
Region Midtjylland
Department of Oncology, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Odense University Hospital
Department of Oncology, J B Winsloews Vej 4, 5000, Odense C
Rigshospitalet
Clinical Research Unit Afsnit 5072, Blegdamsvej 9, 2100, Copenhagen Oe
North Estonia Medical Centre Foundation
Keemiravi keskus, J. Sutiste Tee 19, Mustamae Linnaosa, Tallinn
Centre Hospitalier Universitaire De Dijon
Hepato-Gastroenterology and Oncology, 14 Rue Paul Gaffarel, 21000, Dijon
Hopital Saint Louis
Hepato-Gastroenterology and Digestive Oncology, 1 Avenue Claude Vellefaux, 75010, Paris
Assistance Publique Hopitaux De Paris
Internal Medicine, 51 Av Du Mal De Lattre De Tassigny, 94000, Creteil
Institut De Cancerologie De Lorraine
Medical Oncology, 6 Avenue De Bourgogne, 54500, Vandouvre Les Nancy
Centre Hospitalier Universitaire De Bordeaux
Digestive Oncology, Avenue De Magellan, 33600, Pessac
Hopital Prive Jean Mermoz
Gastro-Enterology and Medical Oncology, 55 Avenue Jean Mermoz, 69008, Lyon
Centre Hospitalier Universitaire De Poitiers
Gastro-Enterology and Medical Oncology, 2 Rue De La Miletrie, 86000, Poitiers
Centre Hospitalier Universitaire De Rennes
Gastro-Enterology, 2 Rue Henri Le Guilloux, 35000, Rennes
Centre Antoine Lacassagne
Medical Oncology, 33 Avenue De Valombrose, 06189, Nice Cedex 2
Institut De Cancerologie De L Ouest
Medical Oncology, Bd Du Professeur Jacques Monod, 44800, St Herblain
University Hospital Of Clermont-Ferrand
Digestive Oncology, 1 Place Lucie Et Raymond Aubrac, 63100, Clermont-Ferrand
Assistance Publique Hopitaux De Paris
Hepato-Gastroenterology, Num Voie 47 A 83, 47 Boulevard De L Hopital, Paris
Assistance Publique Hopitaux De Paris
Hepato-Gastroenterology and Digestive Oncology, 20 Rue Leblanc, 75015, Paris
Institut Gustave Roussy
Gastro-Enterology and Medical Oncology, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Hospitalier Universitaire De Saint Etienne
Hepato-Gastroenterology and Digestive Oncology, Avenue Albert Raimond, 42270, Saint Priest En Jarez
Institut Regional Du Cancer De Montpellier
Medical Oncology, 208 Avenue Des Apothicaires, 34090, Montpellier
Centre Hospitalier Universitaire Reims
Gastro-Enterology and Digestive Oncology, Rue Du General Koenig, 51092, Reims Cedex
Universitaetsklinikum Essen AöR
Department of Medical Oncology, Hufelandstrasse 55, Holsterhausen, Essen
RKH Klinken Ludwigsburg-Bietigheim gGmbH
Klinik f. Innere Medizin, Gastroenterologie, Haemato-Onkologie, Pneumologie, Diabetologie u Infekt, Posilipostrasse 4, Mitte, Ludwigsburg
Haematologisch Onkologische Praxis Eppendorf / Norddeutsches Studienzentrum für Innovative Onkologie
NA, Eppendorfer Landstrasse 42, 20249, Hamburg
Klinikum Wolfsburg
Medizinische Klinik II, Sauerbruchstrasse 7, Klieversberg, Wolfsburg
Klinikum Chemnitz gGmbH
Internal medicine III, Flemmingstrasse 2, Altendorf, Chemnitz
Klinikum der Universitaet Muenchen AöR
Department of Medical Oncology and Hematology, Marchioninistrasse 15, Hadern, Munich
Universitaetsklinikum Ulm AöR
Zentrum fuer Innere Medizin. Klinik für Innere Medizin I, Albert-Einstein-Allee 23, Eselsberg, Ulm
Charite Universitaetsmedizin Berlin KöR
Medizinische Klinik mit Schwerpunkt Haematologie, Onkologie und Tumorimmunologie, Augustenburger Platz 1, Wedding, Berlin
Krankenhaus Nordwest GmbH
Institut fuer Klinische Krebsforschung (IKF), Steinbacher Hohl 2-26, Praunheim, Frankfurt Am Main
Technische Universitat Dresden
Medizinische Klinik und Poliklinik I, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Genesis Mikti Idiotiki Kliniki Gynaikas A.E. Maieutiki Gynaikologiki Cheirourgiki
Oncology Department, 17th Noemvri Street, Pylaia, Thessaloniki
Athens Medical Center S.A.
4th Department of Medical Oncology, Pylea, Asklipiou 10, Thessaloniki
Metaxa Cancer Center Hospital Of Piraeus
Medical Oncology Department, Botassi 51, 185 37, Pireas
St. Luke's Hospital S.A.
Oncology Department, Harilaou Trikoupi Str. 3, 552 36, Thessaloniki
Athens Medical Center S.A.
Oncology Department, Pylea, Asklipiou 10, Thessaloniki
Athens Medical Center S.A.
Oncology Department, Adersen 1, 115 25, Athens
St Savas Hospital
2nd Medical Oncology Department, Alexandras Avenue 171, 115 22, Athens
General University Hospital Of Larissa
Department of Medical Oncology, P. O. Box 1425, 411 10, Larissa
Evangelismos S.A.
Oncology Department, Ipsiladou 45-47, 106 76, Athens
Areteio Hospital
B’ Surgical Clinic-Oncology Unit, Vassilissas Sofias Avenue 76, 115 28, Athens
Metropolitan Hospital
A Oncology Clinic, Ethnarchi Makariou 9, 185 47, Pireas
St. Luke's Hospital S.A.
Department of Medical Oncology, Harilaou Trikoupi Str. 3, 552 36, Thessaloniki
Diagnostic & Therapeutic Center Of Athens Hygeia Single Member S.A.
3rd Department of Medical Oncology, Erithrou Stavrou 4, 151 24, Maroussi
Bioclinic S.A.
Oncology Department, Mitropoleos 86, 546 22, Thessaloniki
Semmelweis University
Pankreasz Betegsegek Intezete, Tomo Utca 25-29, 1083, Budapest VIII
Bekes Varmegyei Koezponti Korhaz
Pandy Kalman Tagkorhaz Megyei Onkologia és Sugartherapias Centrum, Semmelweis Utca 1, 5700, Gyula
Somogy Varmegyei Kaposi Mor Oktato Korhaz
Klinikai Onkologiai Osztaly, Tallian Gyula Utca 20-32, 7400, Kaposvar
Orszagos Onkologiai Intezet
Mellkasi es Hasuregi Daganatok es Klinikai Farmakologiai Osztaly, Rath Gyorgy Utca 7-9, Kerulet, Budapest XII
University Of Debrecen
Onkologiai Klinika, Nagyerdei Korut 98, 4032, Debrecen
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet
Megyei Onkologiai Centrum, Toszegi Ut 21, 5000, Szolnok
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
Nyiregyhazi Josa Andras Tagkorhaz Onkoradiologiai Osztaly, Szent Istvan Utca 68, 4400, Nyiregyhaza
Azienda Sanitaria Universitaria Friuli Centrale
Dipartimento di Oncologia, Piazzale Santa Maria Della Misericordia 15, 33100, Udine
Azienda Unita Sanitaria Locale Della Romagna
oncologia, Via Alcide De Gasperi 8, 48121, Ravenna
ARNAS Civico Di Cristina Benfratelli
Unità Operativa Complessa di Oncologia Medica, Piazza Nicola Leotta 4, 90127, Palermo
Humanitas Research Hospital
Oncologia, Via Alessandro Manzoni 56, 20089, Rozzano
Azienda Sanitaria Territoriale Di Pesaro E Urbino
Oncologia, Piazzale Carlo Cinelli N 4, 61121, Pesaro
Casa Sollievo Della Sofferenza
Unita Operativa Complessa Oncologia, Viale Convento Cappuccini 1, 71013, San Giovanni Rotondo
IRCCS Ospedale Policlinico San Martino
Unita Operativa Oncologia Medica, Largo Rosanna Benzi 10, 16132, Genoa
Istituto Oncologico Veneto
Unità Operativa Complessa Oncologia Medica 1, Via Gattamelata 64, 35128, Padova
ASST Grande Ospedale Metropolitano Niguarda
Oncologia Medica, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Fondazione IRCCS Istituto Nazionale Dei Tumori
Studi Clinici e Sperimentali, Via Giacomo Venezian 1, 20133, Milan
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Unita Operativa Complessa Oncologia Medica, Largo Francesco Vito 1, 00168, Rome
Azienda Ospedaliera Universitaria Integrata Verona
oncologia, Piazzale Aristide Stefani 1, 37126, Verona
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Unita Operativa Oncologia Medica, Via Piero Maroncelli 40, 47014, Meldola
Azienda Ospedaliero Universitaria Pisana
Unità Operativa Oncologia Medica, Via Roma 67, 56126, Pisa
National Institute Of Gastroenterology Saverio De Bellis Research Hospital
Oncologia Medica, Via Turi 27, 70013, Castellana Grotte
Azienda Ospedaliero Universitaria Ospedali Riuniti
Struttura Complessa di Oncologia Medica, Viale Luigi Pinto 1, 71122, Foggia
Careggi University Hospital
Oncologia Medica I, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Azienda Ospedaliera Dei Colli
Unita Operativa Complessa di Oncologia, Via Leonardo Bianchi, 80131, Naples
Fondazione Poliambulanza
Unita Operativa Oncologia Medica, Via Leonida Bissolati 57, 25124, Brescia
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Oncologia Medica, Via Mariano Semmola 52, 80131, Naples
Stichting Martini Ziekenhuis
Medical Oncology, Van Swietenplein 1, 9728 NT, Groningen
University Hospital Maastricht
Internal Medicine, P Debyelaan 25, 6229 HX, Maastricht
Medisch Spectrum Twente
Medical Oncology, Koningsplein 1, 7512 KZ, Enschede
Universitair Medisch Centrum Utrecht
Medical Oncology, Heidelberglaan 100, 3584 CX, Utrecht
Albert Schweitzer Ziekenhuis
Oncology, Albert Schweitzerplaats 25, 3318 AT, Dordrecht
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Gastrointestinal liver oncology, Plesmanlaan 121, 1066 CX, Amsterdam
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
Oncology, Ul. Woloska 137, 02-507, Warsaw
Opolskie Centrum Onkologii Im. Prof. Tadeusza Koszarowskiego W Opolu Samodzielny Publiczny Zaklad Opieki Zdrowotnej
Oncology, Ul. Katowicka 66a, 45-061, Opole
Wielkopolskie Centrum Onkologii Im. Marii Sklodowskiej-Curie
Oncology, Ul. Garbary 15, 61-866, Poznan
Uniwersytecki Szpital Kliniczny Nr 1 Im. Prof. Tadeusza Sokolowskiego Pum W Szczecinie
Oncology, Ul. Unii Lubelskiej 1, 71-252, Szczecin
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
Oncology, Ulica Szaserow 128, 04-141, Warsaw
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Oncology, Ul. Wawelska 15, 02-034, Warsaw
Szpitale Pomorskie Sp. z o.o.
Oncology, Ul. Powstania Styczniowego 1, 81-519, Gdynia
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach
Oncology, Ul. Prezydenta Stefana Artwinskiego 3, 25-734, Kielce
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
Oncology, Ul. Pabianicka 62, 93-513, Lodz
Unidade Local De Saude De Santa Maria E.P.E.
Servico Oncologia Medica, Avenida Professor Egas Moniz, 1649-035, Lisbon
Hospital Cuf Tejo S.A.
Servico de Oncologia, Avenida 24 De Julho 171a, 1350-345, Lisbon
Hospital Da Luz S.A.
Servico de Oncologia, Avenida Lusiada 100, 1500-650, Lisbon
Champalimaud Clinical Centre
Unidade de Digestivos, Avenida Brasilia S/n, 1400-038, Lisbon
Unidade Local De Saude De Coimbra E.P.E.
Servico Oncologia Medica, Praceta Professor Mota Pinto, 3004-561, Coimbra
Unidade Local De Saude De Entre O Douro E Vouga E.P.E.
Servico Oncologia Medica, Rua Doutor Candido Pinho, 4520-211, Santa Maria Da Feira
Unidade Local De Saude De Matosinhos E.P.E.
Servico de Oncologia, Rua Doutor Eduardo Torres, 4464-513, Senhora Da Hora
Instituto Portugues De Oncologia Coimbra Francisco Gentil E.P.E.
Servico de Oncologia Medica, Avenida Doutor Bissaya Barreto 98, 3000-075, Coimbra
Unidade Local De Saude De Almada-Seixal E.P.E.
Servico de Oncologia Medica, Avenida Torrado Da Silva, 2805-267, Almada
Spitalul Municipal Ploiesti
Medical Oncology, Strada Ipatescu Ana Nr 59, 100337, Ploiesti
Oncomed S.R.L.
Medical Oncology, Strada Porumbescu Ciprian Nr 59, 300239, Timisoara
Institutul Regional De Oncologie Iasi
Medical Oncology, Strada Sararie 177b, 700451, Jassi
Institutul Clinic Fundeni
Medical Oncology, Soseaua Fundeni 258, 022328, Bucharest
Centrul De Oncologie SF Nectarie S.R.L.
Medical Oncology, Strada Caracal Nr 109, 200542, Craiova
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
Medical Oncology, Soseaua Fundeni 252, 022328, Bucharest
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Medical Oncology, Strada Republicii 34-36, 400015, Cluj-Napoca
Narodny Onkologicky Ustav
Oddelenie klinickej onkologie E, Klenova 1, Nove Mesto, Bratislava
Vychodoslovensky Onkologicky Ustav a.s.
Oddelenie klinickej onkologie, Rastislavova 43, Juh, Kosice
Institut Catala D'oncologia
Oncology, Carretera Canyet S/n, 08916, Badalona
Hospital Universitario 12 De Octubre
Oncology, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Universitario Virgen De Las Nieves
Oncology, Avenida De Las Fuerzas Armadas 2, 18014, Granada
Hospital Clinico Universitario De Valencia
Oncology, Avenida Blasco Ibanez 17, 46010, Valencia
University Hospital Virgen Del Rocio S.L.
Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario Central De Asturias
Oncology, Avenida De Roma S/n, 33011, Oviedo
Complejo Hospitalario Universitario De Ourense
Oncology, Calle De Ramon Puga Noguerol Nº 52, 32005, Ourense
Hospital Universitario Regional De Malaga
Oncology, Avenida De Carlos De Haya Sn, 29010, Malaga
Hospital General Universitario Gregorio Maranon
Oncology, Calle Del Doctor Esquerdo 46, 28009, Madrid
Universidad De Navarra
Oncology, Irunlarrea Kalea S/n, 31008, Pamplona
Hospital Universitario La Paz
Oncology, Paseo De La Castellana 261, 28046, Madrid
Hospital General Universitario Reina Sofia
Oncology, Avenida Menendez Pidal S/n, 14004, Cordoba
Hospital General Universitario De Valencia
Oncology, Avenida Del Tres Cruces 2, 46014, Valencia
Institut Catala D'oncologia
Servicio de Oncologia Medica, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital De La Santa Creu I Sant Pau
Oncology, Carrer De San Quinti 89, 08041, Barcelona
Hospital Unviersitario Miguel Servet
Oncology, Paseo De Isabel La Catolica 1-3, 50009, Zaragoza
Hospital Universitari Vall D Hebron
Oncology, Edificio Materno-Infantil, Passeig De La Vall D'Hebron 119-129, Barcelona
Area De Salud De Burgos Y Soria
Oncology, Avenida De Las Islas Baleares 3, 09006, Burgos
Hospital Universitario Marques De Valdecilla
Oncology, Avenida Valdecilla Sn, 39008, Santander
Hospital General Universitario De Elche
Oncology, Edificio 2, Camino De La Almazara 11, Elche
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 | 2025-02-21 | 2025-08-22 | |||
| Belgium | 2025-03-06 | 2025-03-10 | |||
| Bulgaria | 2025-02-19 | 2026-01-09 | |||
| Czechia | 2025-02-19 | 2025-02-28 | |||
| Denmark | 2025-02-14 | 2025-04-15 | |||
| Estonia | 2025-02-10 | 2025-12-08 | |||
| France | 2025-03-20 | 2025-03-26 | |||
| Germany | 2025-02-11 | 2025-04-02 | |||
| Greece | 2025-02-28 | 2025-03-19 | |||
| Hungary | 2025-02-10 | 2025-04-17 | |||
| Italy | 2025-03-18 | 2025-04-29 | |||
| Netherlands | 2025-03-31 | 2025-04-18 | |||
| Poland | 2025-05-30 | 2025-07-29 | |||
| Portugal | 2025-03-05 | 2025-04-14 | |||
| Romania | 2025-02-28 | 2025-03-24 | |||
| Slovakia | 2026-05-11 | 2026-05-14 | |||
| Spain | 2025-02-10 | 2025-02-12 | |||
| Sweden | 2025-03-18 | 2025-04-03 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 235 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_ENG_2022-502352-31_20210081_For Publication | 6 |
| Recruitment arrangements (for publication) | K1 Recruitment arrangements For Publication | 2.0 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements Recruitment Procedure | 2.0 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements_For Publication | 2.0 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements_For publication | 4.0 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed consent procedure_For Publication | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements FP | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements Procedure fp | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements Recruitment Procedure FP | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_Austria_20210081_for publication | V2 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_Austria_20210081_TC_Not for publication | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_For Publication | 3.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_For Publication | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_FP | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_FP | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_FP | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_FP | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_FP | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_Germany_20210081_fP | 3.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Recruitment Procedure FP | 4 |
| Recruitment arrangements (for publication) | K2_ Recruitment material Patient study brochure FP | 1.1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material Physician Referral Letter FP | 3.0 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Physician Referral Letter_For Publication | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material _Physician Referral Letter_Germany_20210081_FP | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material Brochure CRC fp | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Patient Brochure_Estonian FP | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material Patient Brochure_Russian FP | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment Material Physician Facing Referral Email | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment Material Physician Facing Referral Letter | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment Material Physician Referral Letter Email Template | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Physician Referral Letter Email Template_EN_FP | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Physician Referral Letter Email Template_FR_FP | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Physician Referral Letter Email Template_NL_FP | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Physician Referral Letter FP | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Physician Referral Letter_EN_FP | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Physician Referral Letter_FP | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material Physician Referral Letter_FR_FP | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Physician Referral Letter_NL_FP | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Referral letter fp | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material Study Brochure_Clean | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ Physician Referral Letter _FP | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Austria_20210081_12005_Homepage text | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Austria_20210081_Patient Brochure | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Austria_20210081_Physician Referral Letter | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure EU Subject Facing_For Publication | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Codebreak_Brochure_CRC_For Publication | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CRC brochure_For Publication | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Dr to Dr letter_FP | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Patient Brochure_Germany_20210081_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Brochure_RO_FP | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patients Brochure_For Publication | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Physician Referral Letter_For Publication | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Physician Referral Facing_For Publication | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Physician Referral Letter Email_RO_FP | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Physician Referral Letter_For Publication | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Physician Referral Letter_Germany_20210081_FP | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Physician Referral Letter_RO_FP | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_Referral Letter_For Publication | 3.0 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Future Research For Publication | 5.0 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Genetic Research For Publication | 5.0 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF MAIN FP | 5.1 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Proteomic Blood Collection For Publication | 5.0 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Tumor Biopsy For Publication | 5.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Confidential 1 Est_FP | 20JUN2024 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Confidential 1 Ru_FP | 20JUN2024 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Confidential 2 Est_FP | 20JUN2024 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Confidential 2 Ru_FP | 20JUN2024 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Confidential 3 Est_FP | 20JUN2024 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Confidential 3 Ru_FP | 20JUN2024 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Informed Consent Procedure FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Main_For Publication | 6.0 |
| Subject information and informed consent form (for publication) | L1_ SIS-ICF_Confidential 1_20210081_Germany_fP | 2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS-ICF_Confidential 2_20210081_Germany_fP | 2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS-ICF_Confidential 3_20210081_Germany_fP | 2.1 |
| Subject information and informed consent form (for publication) | L1_ SIS-ICF_Confidential 4_20210081_Germany_fP | 2.1 |
| Subject information and informed consent form (for publication) | L1_ SIS-ICF_Main_20210081_Germany_fP | 5.0 |
| Subject information and informed consent form (for publication) | L1_ICF Main Study_EN_FP | 5.0 |
| Subject information and informed consent form (for publication) | L1_ICF Main Study_FR_FP | 5.0 |
| Subject information and informed consent form (for publication) | L1_ICF Main Study_NL_FP | 5.0 |
| Subject information and informed consent form (for publication) | L1_ICF Pregnancy_EN_FP | 1.5 |
| Subject information and informed consent form (for publication) | L1_ICF Pregnancy_FR_FP | 1.5 |
| Subject information and informed consent form (for publication) | L1_ICF Pregnancy_NL_FP | 1.5 |
| Subject information and informed consent form (for publication) | L1_Informed Consent Procedure_Austria_20210081_for publication | 1 |
| Subject information and informed consent form (for publication) | L1_Informed consent procedure_Germany_20210081_fP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults Consent for Confidential 1_English_For Publication | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults Consent for Confidential 1_Translation Bulgarian_For Publication | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults Consent for Confidential 2_English_For Publication | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults Consent for Confidential 2_Translation Bulgarian_For Publication | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults Consent for Confidential 3_English_For Publication | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults Consent for Confidential 3_Translation Bulgarian_For Publication | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults Female Consent Form_English_For Publication | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults Female Consent Form_Translation Bulgarian_For Publication | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults Male Consent Form_English_For Publication | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults Male Consent Form_Translation Bulgarian_For Publication | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_Main ICF_English_For Publication | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_Main ICF_Translation Bulgarian_For Publication | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Alternate Visit Est_FP | 20JUN2024 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Alternate Visit Ru_FP | 20JUN2024 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Alternate Visits FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Appendix_FP | 05FEB2026 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Clincard_For Publication | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Confidential 1_For Publication | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Confidential 2_For Publication | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Confidential 3_For Publication | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Confidential 4 Est_FP | 20JUN2024 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Confidential 4 Ru_FP | 20JUN2024 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF CONFIDENTIAL fp | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Confidential_For Publication | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Female Participant Pregnancy fp | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Female Partner Pregnancy fp | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Future Research_FP | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Genetic Research_FP | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Greenphire_FP | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Local Lab Changes Est_FP | 20JUN2024 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Local Lab Changes Ru_FP | 20JUN2024 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Local Lab Changes_FP | 11MAR2024 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Local Lab FP | 12MAR2024 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Local Labs FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Adult_FP | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Estonian_FP | 05FEB2026 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main fp | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main FP | 05FEB2026 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main RO_FP | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Russian_FP | 05FEB2026 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_ENG_FP | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_For Publication | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_For publication | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_FP | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_FP | 05FEB2026 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Proteomic Blood Colection_FP | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Proteomic Research_FP | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Tumor Biopsy_FP | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pharmacogenetic_FP | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregancy woman_For Publication | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy follow up program - father_FP | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy Follow up program - mother_FP | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy man_For Publication | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Reimbursement_Clean_FP | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Tumor Biopsy_FP | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Withdrawal_For Publication | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Withdrawal_FP | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Child Father_For Publication | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Child Mother_For Publication | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_CONFIDENTIAL_1_For Publication | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_CONFIDENTIAL_2_For Publication | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_CONFIDENTIAL_3_For Publication | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_CONFIDENTIAL_4_For Publication | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_CONFIDENTIAL_D_For Publication | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Confidential_four_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Confidential_FP | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Confidential_one_FP | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Confidential_one_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Confidential_three_FP | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Confidential_three_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Confidential_two_FP | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Confidential_two_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_CONFIDENTIEL_C_For Publication | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_CONFIDENTIEL_For Publication | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_GDPR_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Greenphire_FP | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_enrolled_FP | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_For Publication | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_For Publication | 4.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_new_FP | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Payment Reimbursement Through Greenphire_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy Follow-up Mother_For Publication | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Withdrawal_For Publication | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Pregnancy ICF for Participants_for publication | 3 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Pregnancy ICF for Partners_for publication | 3 |
| Subject information and informed consent form (for publication) | L2 Other subbjet information material GP Letter FP | 4.0 |
| Subject information and informed consent form (for publication) | L2 Other subject information material ICF procedure FP | 2.0 |
| Subject information and informed consent form (for publication) | L2_CRC Patient Study Brochure_EN_FP | 1.1 |
| Subject information and informed consent form (for publication) | L2_CRC Patient Study Brochure_FR_FP | 1.1 |
| Subject information and informed consent form (for publication) | L2_CRC Patient Study Brochure_NL_FP | 1.1 |
| Subject information and informed consent form (for publication) | L2_Informed Consent Procedure fp | 1.0 |
| Subject information and informed consent form (for publication) | L2_Informed Consent Procedure_For Publication | 1.0 |
| Subject information and informed consent form (for publication) | L2_Informed Consent Procedure_FP | 1 |
| Subject information and informed consent form (for publication) | L2_List of patient material documents fp | 3 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Dummy Document ediaries SR touch | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Dummy Document SR Questionnaires FP | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Dummy Documents Dosing Diaries | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Dummy Documents eDiaries PT Guide Screen | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject Information material Informed Consent Procedure_For Publication | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Patient Card Sotorasib | 2.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Patient Card_Folfiri | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Thank you Card FP | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_ClinCard_Bank Transfer FAQ_FP | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_ClinCard_Bank Transfer Standard Message Template_FP | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_GDPR_FP | 3.3 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Informed Consent Procedure FP | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Informed Consent Procedure FP | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Informed Consent Procedure FP | 11FEB2026 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Informed Consent Procedure_For Publication | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Informed Consent Procedure_FP | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Informed consent procedure_FP | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Patient card_FP | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Quick Reference Guide_FP | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Recruitment and Informed consent procedure_For Publication | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Screen report touch_FP | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Screen report_FP | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Study Drug Dosing Instructions and Temporary-Use Diary_FP | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Thank you letter_FP | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Your rights as a trial participant FP | 10MAY2023 |
| Subject information and informed consent form (for publication) | L2_Patient Card fp | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_5-Fluorouracil_ For Publication | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Irinotecan_For Publication | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Leucovorin_For Publication | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Leucovorin_For Publication | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_MVASI_For Publication | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Panitumumab | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Panitumumab_TC | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_AT_DE_2022-502352-31_20210081_Full_For Publication | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_AT_DE_PLPS_2022-502352-31_20210081_For Publication | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BE_DE_PLPS_2022-502352-31_20210081_For Publication | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BE_FR_PLPS_2022-502352-31_20210081_For Publication. | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BE_NL_PLPS_2022-502352-31_20210081_For Publication | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BG_PLPS_2022-502352-31_20210081_For Publication | 5 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_CZ_2022-502352-31_20210081_Full_For Publication | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_CZ_PLPS_2022-502352-31_20210081_For Publication | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_DE_PLPS_2022-502352-31_20210081_For Publication | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ENG_PLPS_2022-502352-31_20210081_For Publication | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ES_2022-502352-31_20210081_Full_For Publication | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ES_PLPS_2022-502352-31_20210081_For Publication | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_FR_PLPS_2022-502352-31_20210081_For Publication | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_GR_PLPS_2022-502352-31_20210081_For Publication | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_HU_PLPS_2022-502352-31_20210081_For Publication | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_IT_2022-502352-31_20210081_For Publication | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_IT_PLPS_2022-502352-31_20210081_For Publication | 5 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_NL_PLPS_2022-502352-31_20210081_For Publication | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_PL_PLPS_2022-502352-31_20210081_For Publication | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_PT_PLPS_2022-502352-31_20210081_For Publication | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_RO_PLPS_2022-502352-31_20210081_For Publication | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_SE_PLPS_2022-502352-31_20210081_For Publication | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_SK_PLPS_2022-502352-31_20210081_For Publication | 2 |
Application history
11 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-08 | Czechia | Acceptable with conditions 2024-07-29
|
2024-07-29 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-10-04 | Czechia | Acceptable 2025-01-27
|
2025-01-27 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-02-26 | Acceptable | 2025-04-22 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-02-26 | Acceptable | 2025-03-17 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-02-28 | Acceptable | 2025-04-14 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-02-28 | Acceptable | 2025-06-10 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-02-28 | Acceptable | 2025-03-28 | |
| 8 | SUBSEQUENT ADDITION OF MSC | APP-8 | 2025-03-19 | 2025-05-29 | ||
| 9 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-09-04 | Czechia | Acceptable with conditions 2025-12-12
|
2025-12-12 |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-01-26 | Acceptable with conditions 2025-12-12
|
2026-01-26 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-8 | 2026-02-12 | Czechia | Acceptable with conditions 2026-05-20
|
2026-05-20 |