Clinical trial • Phase III • Oncology

MK-1084 for Colorectal cancer (KRAS G12C-mutant) | Locally advanced unresectable colorectal cancer | Metastatic colorectal cancer

Phase III trial of MK-1084 for Colorectal cancer (KRAS G12C-mutant) | Locally advanced unresectable colorectal cancer | Metastatic colorectal cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Colorectal cancer (KRAS G12C-mutant) | Locally advanced unresectable colorectal cancer | Metastatic colorectal cancer
Trial Stage
Phase III
Drug Modality
Small molecule | Monoclonal antibody

Key dates

Initial CTIS Submission Date
02-06-2025
First CTIS Authorization Date
17-09-2025

Trial design

Randomised, open-label, mfolfox6 (chemotherapy regimen: oxaliplatin iv — product entry max daily dose 85 mg/m2; fluorouracil iv — product entry max daily dose 1200 mg/m2; calcium folinate/levomefolinate iv — product entry max daily dose 200–400 mg/m2) with or without bevacizumab (bevacizumab iv, product entry max daily dose 5 mg/kg). (dose schedules referenced from imp product entries; full schedule details not provided in the available data.)-controlled Phase III trial in France, Finland, Italy and others.

Randomised
Yes
Open Label
Yes
Comparator
mFOLFOX6 (chemotherapy regimen: oxaliplatin IV — product entry max daily dose 85 mg/m2; fluorouracil IV — product entry max daily dose 1200 mg/m2; calcium folinate/levomefolinate IV — product entry max daily dose 200–400 mg/m2) with or without bevacizumab (bevacizumab IV, product entry max daily dose 5 mg/kg). (Dose schedules referenced from IMP product entries; full schedule details not provided in the available data.)
Biomarker Stratified
True, KRAS G12C mutation (enrolment restricted to participants with KRAS G12C-mutant tumours)
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
377

Eligibility

Recruits 377 No vulnerable population selected (isVulnerablePopulationSelected=false). No specific assent or vulnerable-consent handling is described in the provided eligibility criteria..

Vulnerable Population
No vulnerable population selected (isVulnerablePopulationSelected=false). No specific assent or vulnerable-consent handling is described in the provided eligibility criteria.

Inclusion criteria

  • {"criterion_text":"- Has a histologically confirmed diagnosis of locally advanced unresectable or metastatic (unresectable Stage III or Stage IV as defined by American Joint Committee on Cancer [AJCC] eighth edition) colorectal adenocarcinoma\n- Part 2 only: Has not received systemic anticancer therapy for locally advanced unresectable or metastatic colorectal cancer\n- Tumor tissue demonstrates presence of a Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation\n- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)\n- Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load\n- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable"}

Exclusion criteria

  • {"criterion_text":"- Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn’s disease, ulcerative colitis, chronic diarrhea)\n- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease\n- Has known dihydropyrimidine dehydrogenase (DPD) deficiency\n- HIV-infected participants with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease\n- Has received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization\n- Has 1 or more conditions that, in the opinion of the investigator, make the participant ineligible for treatment with bevacizumab\n- Has known additional malignancy that is progressing or has required active treatment within the past 3 years\n- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis or leptomeningeal disease\n- Has active infection requiring systemic therapy\n- Has history of stem cell/solid organ transplant\n- Has not adequately recovered from major surgery or have ongoing surgical complications.\n- Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Number of Participants Experiencing Dose-Limiting Toxicity (DLT)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Part 1: Number of Participants Who Experience an Adverse Event (AE)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Part 1: Number of Participants Who Discontinue Study Treatment Due to an AE","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Progression-free Survival (PFS)","definition_or_measurement_approach":"PFS per RECIST 1.1 as assessed by blinded independent central review (BICR)"}

Secondary endpoints

  • {"endpoint_text":"- Objective Response Rate (ORR)","definition_or_measurement_approach":"ORR per RECIST 1.1 by blinded independent central review (BICR) (as specified in protocol objectives)"}
  • {"endpoint_text":"- Overall Survival (OS)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Duration of Response (DOR)","definition_or_measurement_approach":"DOR per RECIST 1.1 by BICR (as specified in protocol objectives)"}
  • {"endpoint_text":"- Part 2: Number of Participants Who Experience an AE","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Part 2: Number of Participants Who Discontinue Study Treatment Due to an AE","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score","definition_or_measurement_approach":"Measured using the EORTC QLQ-C30 global health status/quality of life items (Items 29 and 30)"}
  • {"endpoint_text":"- Change from Baseline in the EORTC-QLQ-C30 Physical Functioning (Items 1-5) Score","definition_or_measurement_approach":"Measured using EORTC QLQ-C30 physical functioning items (Items 1-5)"}
  • {"endpoint_text":"- Change from Baseline in the EORTC-QLQ-C30 Role Functioning (Items 6 and 7) Score","definition_or_measurement_approach":"Measured using EORTC QLQ-C30 role functioning items (Items 6 and 7)"}
  • {"endpoint_text":"- Change from Baseline in the EORTC-QLQ-C30 Appetite Loss (Item 13) Score","definition_or_measurement_approach":"Measured using EORTC QLQ-C30 appetite loss item (Item 13)"}
  • {"endpoint_text":"- Change from Baseline in the EORTC-Quality of Life Questionnaire-Colorectal Cancer-Specific 29 Items (QLQ-CR29) Bloating (Item 37) Score","definition_or_measurement_approach":"Measured using EORTC QLQ-CR29 colorectal cancer-specific item for bloating (Item 37)"}
  • {"endpoint_text":"- Time to First Deterioration (TTD) in EORTC QLQ-C30 Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score","definition_or_measurement_approach":"TTD assessed using EORTC QLQ-C30 combined score (Items 29 and 30)"}
  • {"endpoint_text":"- TTD in EORTC QLQ-C30 Physical Functioning (Items 1-5) Score","definition_or_measurement_approach":"TTD assessed using EORTC QLQ-C30 physical functioning (Items 1-5)"}
  • {"endpoint_text":"- TTD in EORTC QLQ-C30 Role Functioning (Items 6 and 7) Score","definition_or_measurement_approach":"TTD assessed using EORTC QLQ-C30 role functioning (Items 6 and 7)"}
  • {"endpoint_text":"- TTD in EORTC QLQ-C30 Appetite Loss (Item 13) Score","definition_or_measurement_approach":"TTD assessed using EORTC QLQ-C30 appetite loss (Item 13)"}
  • {"endpoint_text":"- TTD in EORTC QLQ-CR29 Bloating (Item 37) Score","definition_or_measurement_approach":"TTD assessed using EORTC QLQ-CR29 bloating item (Item 37)"}

Recruitment

Registry Or Advocacy Recruitment
True, documents reference advocacy materials (e.g., "K2_Recruitment Doc Advocacy Card_HUN_HU_IN-RFI008_for pub") and a patient-organisation listed as a site in the Netherlands (Amsterdam UMC Stichting)
Digital Remote Recruitment
True, country recruitment materials include a website recruitment document for Poland ("K2_Recruitment Doc Website_POL_PL_SM02_for pub") and multiple K2 recruitment documents and patient brochures/posters across countries indicating digital/printed outreach
Planned Sample Size
377
Recruitment Window Months
68
Consent Approach
Informed consent is obtained from participants using country-specific informed consent forms. Multiple subject information and informed consent documents are included in the submission (e.g., country-specific Main consent and optional consents listed for France, Finland, Italy, Hungary, Germany, Poland, Romania, Netherlands, Spain). Optional consents referenced include genetic consent, optional limited screening consent, optional pregnant partner follow-up/consent, and other optional forms; consents and materials are available in multiple languages as indicated by the country-specific documents.

Geography

Total Number Of Sites
51
Total Number Of Participants
141

France

Earliest CTIS Part Ii Submission Date
22-08-2025
Latest Decision Or Authorization Date
05-05-2026
Processing Time Days
256
Number Of Sites
11
Number Of Participants
30

Sites

Site Name
Institut Godinot
Department Name
Oncologie
Principal Investigator Name
Damien Botsen
Principal Investigator Email
dbotsen@chu-reims.fr
Contact Person Name
Damien Botsen
Contact Person Email
dbotsen@chu-reims.fr
Site Name
CHRU De Nancy
Department Name
Gastro-entérologie
Principal Investigator Name
Marie Muller
Principal Investigator Email
m.muller7@chru-nancy.fr
Contact Person Name
Marie Muller
Contact Person Email
m.muller7@chru-nancy.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Oncologie
Principal Investigator Name
Thierry Andre
Principal Investigator Email
thierry.andre@aphp.fr
Contact Person Name
Thierry Andre
Contact Person Email
thierry.andre@aphp.fr
Site Name
Centre Hospitalier Universitaire Rouen
Department Name
Hepato-gastroenterologie
Principal Investigator Name
Frederic Di Fiore
Principal Investigator Email
frederic.di-fiore@chu-rouen.fr
Contact Person Name
Frederic Di Fiore
Contact Person Email
frederic.di-fiore@chu-rouen.fr
Site Name
Centre Hospitalier Et Universitaire De Limoges
Department Name
Oncologie
Principal Investigator Name
Frederic Thuillier
Principal Investigator Email
frederic.thuillier@chu-limoges.fr
Contact Person Name
Frederic Thuillier
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Oncologie Digestive
Principal Investigator Name
Claire Gallois
Principal Investigator Email
Claire.gallois@aphp.fr
Contact Person Name
Claire Gallois
Contact Person Email
Claire.gallois@aphp.fr
Site Name
Institut De Cancerologie De L Ouest
Department Name
Oncologie
Principal Investigator Name
Victor Simmet
Principal Investigator Email
victor.simmet@ico.unicancer.fr
Contact Person Name
Victor Simmet
Contact Person Email
victor.simmet@ico.unicancer.fr
Site Name
Centre Francois Baclesse
Department Name
Pathologie Digestive
Principal Investigator Name
Mélanie Dos Santos
Principal Investigator Email
m.dossantos@baclesse.unicancer.fr
Contact Person Name
Mélanie Dos Santos
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Oncologie Médicale Digestive
Principal Investigator Name
Rosine Guimbault
Principal Investigator Email
guimbaud.r@chu-toulouse.fr
Contact Person Name
Rosine Guimbault
Contact Person Email
guimbaud.r@chu-toulouse.fr
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Hépato Gastro-Entérologe et Oncologie Digestive
Principal Investigator Name
Anne Claire Frin
Principal Investigator Email
frin.ac@chu-nice.fr
Contact Person Name
Anne Claire Frin
Contact Person Email
frin.ac@chu-nice.fr
Site Name
Institut Sainte Catherine
Department Name
Oncologie- Radiothérapie
Principal Investigator Name
Laurent Mineur
Principal Investigator Email
l.mineur@isc84.org
Contact Person Name
Laurent Mineur
Contact Person Email
l.mineur@isc84.org

Finland

Earliest CTIS Part Ii Submission Date
18-08-2025
Latest Decision Or Authorization Date
04-05-2026
Processing Time Days
259
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
Tampere University Hospital
Department Name
FONK
Principal Investigator Name
Pia Osterlund
Principal Investigator Email
pia.osterlund@helsinki.fi
Contact Person Name
Pia Osterlund
Contact Person Email
pia.osterlund@helsinki.fi
Site Name
HUS-Yhtymae
Department Name
HUS, Comprehensive Cancer Center
Principal Investigator Name
Sari Jaamaa
Principal Investigator Email
sari.jaamaa@hus.fi
Contact Person Name
Sari Jaamaa
Contact Person Email
sari.jaamaa@hus.fi

Italy

Earliest CTIS Part Ii Submission Date
01-08-2025
Latest Decision Or Authorization Date
04-05-2026
Processing Time Days
276
Number Of Sites
7
Number Of Participants
20

Sites

Site Name
Ospedale San Raffaele S.r.l.
Department Name
Dipartimento di Oncologia Medica
Principal Investigator Name
Monica Ronzoni
Principal Investigator Email
ronzoni.monica@hsr.it
Contact Person Name
Monica Ronzoni
Contact Person Email
ronzoni.monica@hsr.it
Site Name
Istituto Oncologico Veneto
Department Name
UOC Oncologia 1
Principal Investigator Name
Sara Lonardi
Principal Investigator Email
sara.lonardi@iov.veneto.it
Contact Person Name
Sara Lonardi
Contact Person Email
sara.lonardi@iov.veneto.it
Site Name
Azienda Unita Sanitaria Locale Della Romagna
Department Name
UOC Oncologia
Principal Investigator Name
Stefano Tamberi
Principal Investigator Email
ste.tamberi@gmail.com
Contact Person Name
Stefano Tamberi
Contact Person Email
ste.tamberi@gmail.com
Site Name
Azienda Ospedaliero-Universitaria Di Cagliari
Department Name
Oncologia Medica
Principal Investigator Name
Mario Scartozzi
Principal Investigator Email
marioscartozzi@unica.it
Contact Person Name
Mario Scartozzi
Contact Person Email
marioscartozzi@unica.it
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
Oncologia Falck, Dipartimento di Ematologia e Oncologia
Principal Investigator Name
Salvatore Siena
Principal Investigator Email
Salvatore.Siena@OspedaleNiguarda.it
Contact Person Name
Salvatore Siena
Site Name
Azienda Ospedaliera Universita' Degli Studi Della Campania Luigi Vanvitelli
Department Name
UOC Oncoematologia
Principal Investigator Name
Fortunato Ciardiello
Principal Investigator Email
fortunato.ciardiello@unicampania.it
Contact Person Name
Fortunato Ciardiello
Site Name
Azienda Ospedaliera Universitaria Integrata Verona
Department Name
Oncologia
Principal Investigator Name
Davide Melisi
Principal Investigator Email
davide.melisi@univr.it
Contact Person Name
Davide Melisi
Contact Person Email
davide.melisi@univr.it

Hungary

Earliest CTIS Part Ii Submission Date
05-08-2025
Latest Decision Or Authorization Date
04-05-2026
Processing Time Days
272
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
University Of Pecs
Department Name
Onkoterápiás Klinika
Principal Investigator Name
László Mangel
Principal Investigator Email
mangel.laszlo.study@pte.hu
Contact Person Name
László Mangel
Contact Person Email
mangel.laszlo.study@pte.hu
Site Name
Semmelweis University
Department Name
Belgyógyászati és Hematológiai Klinika
Principal Investigator Name
Júlia Lohinszky
Principal Investigator Email
julia.lohinszky@semmelweis.hu
Contact Person Name
Júlia Lohinszky
Contact Person Email
julia.lohinszky@semmelweis.hu

Germany

Earliest CTIS Part Ii Submission Date
28-08-2025
Latest Decision Or Authorization Date
04-05-2026
Processing Time Days
249
Number Of Sites
5
Number Of Participants
10

Sites

Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Med. Klinik m. S. Hämatologie, Onkologie und Tumorimmunologie
Principal Investigator Name
Ivan Jelas
Principal Investigator Email
ivan.jelas@charite.de
Contact Person Name
Ivan Jelas
Contact Person Email
ivan.jelas@charite.de
Site Name
Asklepios Kliniken Hamburg GmbH
Department Name
Hämatologie, internistische Onkologie und Palliativmedizin
Principal Investigator Name
Dirk Arnold
Principal Investigator Email
d.arnold@asklepios.com
Contact Person Name
Dirk Arnold
Contact Person Email
d.arnold@asklepios.com
Site Name
Katholisches Marienkrankenhaus gGmbH
Department Name
Onkologisches Zentrum
Principal Investigator Name
Gunnar Hapke
Principal Investigator Email
hapke.innere@marienkrankenhaus.org
Contact Person Name
Gunnar Hapke
Site Name
Goethe University Frankfurt
Department Name
Medizinische Klinik I, Gastrointestinale Onkologie
Principal Investigator Name
Christine Koch
Principal Investigator Email
Christine.Koch@ukffm.de
Contact Person Name
Christine Koch
Contact Person Email
Christine.Koch@ukffm.de
Site Name
KEM I Evang. Kliniken Essen-Mitte gGmbH
Department Name
Klinik für Internistische Onkologie & Hämatologie mit integrierter Palliativmedizin
Principal Investigator Name
Christian Müller
Principal Investigator Email
Ch.Mueller@kem-med.com
Contact Person Name
Christian Müller
Contact Person Email
Ch.Mueller@kem-med.com

Poland

Earliest CTIS Part Ii Submission Date
13-08-2025
Latest Decision Or Authorization Date
05-05-2026
Processing Time Days
265
Number Of Sites
5
Number Of Participants
25

Sites

Site Name
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
Department Name
Oddział Onkologii Klinicznej z Pododdziałem Chemioterapii Jednodniowej
Principal Investigator Name
Mariusz Kwiatkowski
Principal Investigator Email
sekretariat.odch@swk.med.pl
Contact Person Name
Mariusz Kwiatkowski
Contact Person Email
sekretariat.odch@swk.med.pl
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Klinika Onkologii i Radioterapii
Principal Investigator Name
Lucjan Wyrwicz
Principal Investigator Email
lucjan.wyrwicz@nio.gov.pl
Contact Person Name
Lucjan Wyrwicz
Contact Person Email
lucjan.wyrwicz@nio.gov.pl
Site Name
Mruk-Med I Sp. z o.o.
Principal Investigator Name
Andrzej Mruk
Principal Investigator Email
kmruk1@vp.pl
Contact Person Name
Andrzej Mruk
Contact Person Email
kmruk1@vp.pl
Site Name
Wielkopolskie Centrum Onkologii Im. Marii Sklodowskiej-Curie
Department Name
Oddział Onkologii Klinicznej i Immunoonkologii z Pododdziałem Dziennym i Izbą Przyjęć
Principal Investigator Name
Zuzanna Synowiec
Principal Investigator Email
clinicaltrials@wco.pl
Contact Person Name
Zuzanna Synowiec
Contact Person Email
clinicaltrials@wco.pl
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy (Gliwice)
Department Name
Oddział w Gliwicach Oddział Chemioterapii Dziennej
Principal Investigator Name
Wiesław Bal
Principal Investigator Email
oddzial.chemdziennej@gliwice.nio.gov.pl
Contact Person Name
Wiesław Bal

Romania

Earliest CTIS Part Ii Submission Date
14-08-2025
Latest Decision Or Authorization Date
04-05-2026
Processing Time Days
263
Number Of Sites
6
Number Of Participants
15

Sites

Site Name
Centrul De Oncologie SF Nectarie S.R.L.
Department Name
Oncologie Medicala
Principal Investigator Name
Michael Schenker
Principal Investigator Email
office@centruldeoncologie.ro
Contact Person Name
Michael Schenker
Contact Person Email
office@centruldeoncologie.ro
Site Name
Institutul Regional De Oncologie Iasi
Department Name
Oncologie Medicala
Principal Investigator Name
Vlad Afrasanie
Principal Investigator Email
manager@iroiasi.ro
Contact Person Name
Vlad Afrasanie
Contact Person Email
manager@iroiasi.ro
Site Name
Radiotherapy Center Cluj S.R.L.
Department Name
Oncologie Medicala
Principal Investigator Name
Andrei Ungureanu
Principal Investigator Email
office.otopeni@amethyst-radiotherapy.com
Contact Person Name
Andrei Ungureanu
Site Name
Institutul Regional De Oncologie Iasi (second site)
Department Name
Oncologie Medicala
Principal Investigator Name
Vlad Afrasanie
Principal Investigator Email
manager@iroiasi.ro
Contact Person Name
Vlad Afrasanie
Contact Person Email
manager@iroiasi.ro
Site Name
Institutul Clinic Fundeni
Department Name
Oncologie Medicala
Principal Investigator Name
Adina Croitoru
Principal Investigator Email
secretariat@icfundeni.ro
Contact Person Name
Adina Croitoru
Contact Person Email
secretariat@icfundeni.ro
Site Name
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Department Name
Oncologie Medicala
Principal Investigator Name
Tudor Ciuleanu
Principal Investigator Email
office@iocn.ro
Contact Person Name
Tudor Ciuleanu
Contact Person Email
office@iocn.ro

Netherlands

Earliest CTIS Part Ii Submission Date
10-09-2025
Latest Decision Or Authorization Date
01-05-2026
Processing Time Days
233
Number Of Sites
4
Number Of Participants
8

Sites

Site Name
Amphia Hospital
Department Name
Medical Oncology
Principal Investigator Name
Mirte Streppel
Principal Investigator Email
researchoncologieinterne@amphia.nl
Contact Person Name
Mirte Streppel
Site Name
Amsterdam UMC Stichting
Department Name
Medical Oncology
Principal Investigator Name
Tineke Buffart
Principal Investigator Email
medonc-lowergi-elderly@amsterdamumc.nl
Contact Person Name
Tineke Buffart
Site Name
Radboud universitair medisch centrum Stichting
Department Name
Medical Oncology
Principal Investigator Name
Harm Westdorp
Principal Investigator Email
studies.onco@radboudumc.nl
Contact Person Name
Harm Westdorp
Contact Person Email
studies.onco@radboudumc.nl
Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Medical Oncology
Principal Investigator Name
Hendrik Verheul
Principal Investigator Email
interne.oncologie@erasmusmc.nl
Contact Person Name
Hendrik Verheul
Contact Person Email
interne.oncologie@erasmusmc.nl

Spain

Earliest CTIS Part Ii Submission Date
14-08-2025
Latest Decision Or Authorization Date
05-05-2026
Processing Time Days
264
Number Of Sites
9
Number Of Participants
21

Sites

Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Medical Oncology
Principal Investigator Name
Pilar Garcia Alfonso
Principal Investigator Email
pgarcaalfonso@gmail.com
Contact Person Name
Pilar Garcia Alfonso
Contact Person Email
pgarcaalfonso@gmail.com
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Medical Oncology
Principal Investigator Name
Carlos Lopez Lopez
Principal Investigator Email
carlos.lopez@scsalud.es
Contact Person Name
Carlos Lopez Lopez
Contact Person Email
carlos.lopez@scsalud.es
Site Name
Complejo Hospitalario Universitario Insular Materno Infantil
Department Name
Medical Oncology
Principal Investigator Name
Delvis Rodriguez Abreu
Principal Investigator Email
drodabr@gobiernodecanarias.org
Contact Person Name
Delvis Rodriguez Abreu
Contact Person Email
drodabr@gobiernodecanarias.org
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncología Médica
Principal Investigator Name
Francisco Javier Ros Montaña
Principal Investigator Email
fjros@vhio.net
Contact Person Name
Francisco Javier Ros Montaña
Contact Person Email
fjros@vhio.net
Site Name
Hospital Clinico San Carlos
Department Name
Medical Oncology
Principal Investigator Name
Javier Sastre Valera
Principal Investigator Email
jsastrev@salud.madrid.org
Contact Person Name
Javier Sastre Valera
Contact Person Email
jsastrev@salud.madrid.org
Site Name
Hospital Universitario Central De Asturias
Department Name
Medical Oncology
Principal Investigator Name
Paula Jimenez Fonseca
Principal Investigator Email
palucaji@hotmail.com
Contact Person Name
Paula Jimenez Fonseca
Contact Person Email
palucaji@hotmail.com
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Medical Oncology
Principal Investigator Name
Maria Luisa Limon Miron
Principal Investigator Email
mllimon02@hotmail.com
Contact Person Name
Maria Luisa Limon Miron
Contact Person Email
mllimon02@hotmail.com
Site Name
Fundacion Instituto Valenciano De Oncologia
Department Name
Oncology
Principal Investigator Name
Marcos Melían Sosa
Principal Investigator Email
mmelian@fivo.org
Contact Person Name
Marcos Melían Sosa
Contact Person Email
mmelian@fivo.org
Site Name
Institut Catala D'oncologia
Department Name
Medical Oncology
Principal Investigator Name
Nuria Mulet Margalef
Principal Investigator Email
nmulet@iconcologia.net
Contact Person Name
Nuria Mulet Margalef
Contact Person Email
nmulet@iconcologia.net

Sponsor

Primary sponsor

Full Name
Merck Sharp & Dohme LLC
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Icon Clinical Research Limited
Responsibilities
sponsorDuties codes: 4
Name
Parexel International Corp.
Responsibilities
sponsorDuties codes: 15 (EUB services (call center and medical services))
Name
Almac Clinical Technologies LLC
Responsibilities
sponsorDuties codes: 3
Name
Syneos Health Clinique Inc.
Responsibilities
sponsorDuties codes: 4

Third parties

  • {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"sponsorDuties codes: 3","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Hematogenix Laboratory Services LLC","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"sponsorDuties codes: 15 (Imaging)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"sponsorDuties codes: 15 (EUB services (call center and medical services))","organisation_type":"Pharmaceutical company"}
  • {"country":"Canada","full_name":"Syneos Health Clinique Inc.","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United Kingdom","full_name":"Signant Health Management Limited","duties_or_roles":"sponsorDuties codes: 7","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
MK-1084
Active Substance
MK-1084
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Investigational / not authorised (no marketing authorisation number in product entry)
Investigational Product Name
CETUXIMAB
Active Substance
CETUXIMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Authorisation Status
Not stated (product entry marketing authorisation number not provided in record)
Maximum Dose
500 mg/m2 (product entry maxDailyDoseAmount)
Investigational Product Name
BEVACIZUMAB (Avastin / MVASI)
Active Substance
BEVACIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Authorisation Status
Authorised (marketing authorisation numbers listed for Avastin/MVASI products where present)
Maximum Dose
5 mg/kg (product entry maxDailyDoseAmount)
Investigational Product Name
OXALIPLATIN
Active Substance
OXALIPLATIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Authorisation Status
Not stated (product entry marketing authorisation number not provided in record)
Maximum Dose
85 mg/m2 (product entry maxDailyDoseAmount)
Investigational Product Name
FLUOROURACIL
Active Substance
FLUOROURACIL
Modality
Small molecule
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Authorisation Status
Not stated (product entry marketing authorisation number not provided in record)
Maximum Dose
1200 mg/m2 (product entry maxDailyDoseAmount)
Investigational Product Name
CALCIUM FOLINATE / CALCIUM LEVOFOLINATE
Active Substance
CALCIUM FOLINATE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Authorisation Status
Not stated (scientific product entries present)
Maximum Dose
200–400 mg/m2 (product entry maxDailyDoseAmount varies by product entry)
Combination Treatment
Yes

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