Clinical trial • Phase III • Oncology

FRUQUINTINIB for Metastatic oesophagogastric adenocarcinoma

Phase III trial of FRUQUINTINIB for Metastatic oesophagogastric adenocarcinoma.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Metastatic oesophagogastric adenocarcinoma
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
09-07-2025
First CTIS Authorization Date
04-11-2025

Trial design

Randomised, comparator: lonsurf 15 mg/6.14 mg film-coated tablets and lonsurf 20 mg/8.19 mg film-coated tablets (trifluridine/tipiracil) as monotherapy (arm a) versus trifluridine/tipiracil plus fruquintinib (fruzaqla 1 mg and 5 mg hard capsules) (arm b). dose schedule not specified in the provided record.-controlled Phase III trial in France, Germany, Spain.

Randomised
Yes
Comparator
Comparator: Lonsurf 15 mg/6.14 mg film-coated tablets and Lonsurf 20 mg/8.19 mg film-coated tablets (trifluridine/tipiracil) as monotherapy (Arm A) versus trifluridine/tipiracil plus fruquintinib (FRUZAQLA 1 mg and 5 mg hard capsules) (Arm B). Dose schedule not specified in the provided record.
Target Sample Size
324

Eligibility

Recruits 324 isVulnerablePopulationSelected is true. Consent requirement: 'Patient is able to understand, sign, and date the written informed consent form at the screening visit prior to any protocol-specific procedures performed.' All participants must be ≥ 18 years. No specific assent procedures or paediatric consent described..

Pregnancy Exclusion
Pregnant or breastfeeding female patient
Vulnerable Population
isVulnerablePopulationSelected is true. Consent requirement: 'Patient is able to understand, sign, and date the written informed consent form at the screening visit prior to any protocol-specific procedures performed.' All participants must be ≥ 18 years. No specific assent procedures or paediatric consent described.

Inclusion criteria

  • {"criterion_text":"- Age ≥ 18 years (patients enrolled gender independently).\n- Man and woman of childbearing potential agrees to use two methods (one for the patient and one for the partner) of medically acceptable forms of contraception during the study and for 6 months after the last treatment intake.\n- Patient is able to understand, sign, and date the written informed consent form at the screening visit prior to any protocol-specific procedures performed.\n- Available tumor block (surgical specimens of primary tumor and if not available tumor biopsies).\n- Patient willing to participate to biological studies\n- Histologically proven metastatic adenocarcinoma of the stomach or the esophagogastric junction (GEJ) or esophagus.\n- Prior treatment by two or three lines of treatment for metastatic setting (patients who received adjuvant therapy and developed metastatic disease within 6 months of completing treatment should be considered as having failed first-line therapy for metastatic disease).\n- Prior treatment (progression or intolerance) with platinum salts (oxaliplatin or cisplatin), fluoropyrimidine and irinotecan and/or taxane (+/- anti-HER2 agents +/- immune checkpoint inhibitors +/- ramucirumab +/- anti-claudin 18.2).\n- Measurable or non-measurable lesions. (Response Evaluation Criteria in Solid Tumors (RECIST 1.1)\n- World Health Organisation (WHO) performance status 0-1.\n- Adequate organ function: ANC ≥ 1.5 x 109/L, hemoglobin ≥ 9 g/dL, platelets ≥ 100 G/L, AST/ALT ≤ 3 x ULN (≤ 5 x ULN in case of liver metastase(s)), total bilirubin ≤ 1.5 x ULN, creatinine clearance > 30 mL/min (CKD EPI).\n- Adequate coagulation tests (INR and activated partial thromboplastin time (APTT) ≤1.5 × ULN) unless the patient is receiving anticoagulant therapy.\n- Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients."}

Exclusion criteria

  • {"criterion_text":"- Concurrent enrolment in another clinical study – unless it is an observational study or during the follow-up for survival status update only of an interventional study.\n- Gastric or duodenal active ulcer\n- Thromboembolic events (including deep vein thrombosis and pulmonary embolism) in the past 6 months\n- Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, uncontrolled hypertension (defined as systolic blood pressure ≥140 mm Hg and/or diastolic blood pressure ≥90 mm Hg despite optimal medical management), interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea\n- Psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.\n- Patients with urine protein test 2+ or more and 24 hours urine protein>=1.0g/24h.\n- Known positive test for HIV, active hepatitis B or hepatitis C, active tuberculosis.\n- Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients. (excipients with known effects and potential risk of allergies : tartrazine (E102) ,sunset yellow FCF (E110), Lactose monohydrate).\n- Prior treatment with trifluridine/tipiracil and/or fruquintinib and/or regorafenib and/or any anti-VEGFR tyrosine kinase inhibitor.\n- Active infection requiring intravenous antibiotics at the time of Day 1 of Cycle 1.\n- Other malignancy within 3 years prior to study enrolment, except for localized cancer in situ, basal or squamous cell skin cancer or other localized tumor with complete resection.\n- Administration of the last dose of anticancer therapy and palliative radiotherapy ≤ 2 weeks prior to the first dose of study drug.\n- Treatment with powerful CYP 450 inducers (no contraindication for inhibitors)\n- Pregnant or breastfeeding female patient\n- Congenital galactosemia, total lactase deficiency (lactose intolerance) or glucose-galactose malabsorption syndrome.\n- Patients with clinically significant bleeding within the past 2 months.\n- Current or prior bowel obstruction within 28 days before the first dose of study drugs.\n- Any unresolved clinical significant toxicity NCI CTCAE v5.0 ≥ grade 2 from previous anticancer therapy (except neuropathy).\n- More than 3 prior lines of treatment\n- Major surgical procedure (e.g. exploratory laparoscopy is not considered as a major surgical procedure) within 2 weeks prior to the first dose of treatment.\n- History of leptomeningeal carcinomatosis or symptomatic or untreated brain metastase(s). Patients whose brain metastase(s) have been treated may participate if any neurologic symptoms that developed as a result of the brain metastases are resolved or stable.\n- Severe cardiac disorders (including but not limited to acute myocardial infarction, stroke, unstable angina, NYHA class III/IV heart failure, or LVEF<50%) within 6 months.\n- Severe liver dysfunction (cirrhosis Child Pugh B or C)."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Overall survival (OS) and is defined as the time between the date of randomization and the date of death caused by any reason or the date of last news if the patient is alive.","definition_or_measurement_approach":"Overall survival (OS) and is defined as the time between the date of randomization and the date of death caused by any reason or the date of last news if the patient is alive."}

Secondary endpoints

  • {"endpoint_text":"- Progression-free survival (PFS) is defined as the time between date of randomization and the date of first radiological progression according to RECIST 1.1 or death (whichever occurs first). Patients alive without progression will be censored to the date of last radiologic assessment.","definition_or_measurement_approach":"Time from randomization to first radiological progression per RECIST 1.1 or death; censoring at last radiologic assessment if alive without progression."}
  • {"endpoint_text":"- Time to progression (TTP) is defined as the time between date of randomization and the date of first radiological progression (according to RECIST v1.1). Patients without progression will be censored at date of last radiologic assessment or date of death. The death will not be considered as an event","definition_or_measurement_approach":"Time from randomization to first radiological progression per RECIST 1.1; death is not considered an event; censor at last radiologic assessment or date of death if no progression."}
  • {"endpoint_text":"- Best Objective response rate (ORR) and disease control rate (DCR) is defined as incidence of a complete or partial response during treatment for ORR and a complete or partial or a stability for DCR. ORR and DCR will be provided as overall best response and at 2, 3, 6 and 9 months.","definition_or_measurement_approach":"ORR = incidence of complete or partial response; DCR = complete, partial or stable disease; reported as overall best response and at 2, 3, 6 and 9 months."}
  • {"endpoint_text":"- Safety profile: TEAEs will be graded according to the NCI-CTCAE v5.0 classifications.","definition_or_measurement_approach":"Treatment-emergent adverse events graded per NCI-CTCAE v5.0."}
  • {"endpoint_text":"- Quality of life (QoL) will be evaluated using EORTC QLQ-C30 and the STO22 questionnaires.","definition_or_measurement_approach":"Patient-reported QoL assessed using EORTC QLQ-C30 and STO22 instruments."}

Recruitment

Planned Sample Size
324
Recruitment Window Months
36
Consent Approach
Informed consent must be provided by the patient: 'Patient is able to understand, sign, and date the written informed consent form at the screening visit prior to any protocol-specific procedures performed.' Participants are adults (Age ≥ 18 years). Patient-facing information and ICF documents are available in French, German and Spanish (document titles indicate FR, DE, SPA versions). No assent procedures are described.

Geography

Total Number Of Sites
77
Total Number Of Participants
324

France

Earliest CTIS Part Ii Submission Date
25-09-2025
Latest Decision Or Authorization Date
10-11-2025
Processing Time Days
46
Number Of Sites
55
Number Of Participants
176

Sites

Site Name
Institut Bergonie
Department Name
gastro enterology
Principal Investigator Name
LOLA JADE PALMIERI
Principal Investigator Email
l.palmieri@bordeaux.unicancer.fr
Contact Person Name
LOLA JADE PALMIERI
Site Name
Clinique De Flandre
Department Name
oncology
Principal Investigator Name
Jean Baptiste AISENFARB
Principal Investigator Email
jbaisenfarb@iadonco.org
Contact Person Name
Jean Baptiste AISENFARB
Contact Person Email
jbaisenfarb@iadonco.org
Site Name
Groupe Hospitalier Nord Essonne
Department Name
Digestive Oncology
Principal Investigator Name
Andrei Dan HAVASI
Principal Investigator Email
a.havasi@ghne.fr
Contact Person Name
Andrei Dan HAVASI
Contact Person Email
a.havasi@ghne.fr
Site Name
CLINIQUE MUTUALISTE DE L'ESTUAIRE
Department Name
Médical Oncology
Principal Investigator Name
manon baverez
Principal Investigator Email
manon.baverez@hospigrandouest.fr
Contact Person Name
manon baverez
Site Name
Centre de Radiothérapie - Clinique Sainte Anne
Department Name
oncology
Principal Investigator Name
Louis Marie DOURTHE
Principal Investigator Email
lm.dourthe@solcrr.org
Contact Person Name
Louis Marie DOURTHE
Contact Person Email
lm.dourthe@solcrr.org
Site Name
Centre Hospitalier Jean Rougier
Department Name
Médical Oncology
Principal Investigator Name
Maher NASRI
Principal Investigator Email
maher.nasri@ght-lot.fr
Contact Person Name
Maher NASRI
Contact Person Email
maher.nasri@ght-lot.fr
Site Name
HIA Sainte Anne
Department Name
hépato gastro enterology
Principal Investigator Name
Caroline PRIEUX-KLOTZ
Principal Investigator Email
caroline.klotz@intradef.gouv.fr
Contact Person Name
Caroline PRIEUX-KLOTZ
Site Name
Centre Hospitalier Aunay Bayeux
Department Name
hépato gastro enterology/digestive oncology
Principal Investigator Name
Annie PEYTIER
Principal Investigator Email
a.peytier@ch-ab.fr
Contact Person Name
Annie PEYTIER
Contact Person Email
a.peytier@ch-ab.fr
Site Name
Centre Hospitalier Universitaire De Saint Etienne
Department Name
gastro enterology/Digestive oncology
Principal Investigator Name
Jean-Marc PHELIP
Principal Investigator Email
j.marc.phelip@chu-st-etienne.fr
Contact Person Name
Jean-Marc PHELIP
Site Name
Centre Hospitalier Universitaire Reims
Department Name
hépato gastro enterology
Principal Investigator Name
Olivier Bouché
Principal Investigator Email
obouche@chu-reims.fr
Contact Person Name
Olivier Bouché
Contact Person Email
obouche@chu-reims.fr
Site Name
GHBS Lorient
Department Name
Médical Oncology
Principal Investigator Name
Edwina GIRARD
Principal Investigator Email
e.girard@ghbs.bzh
Contact Person Name
Edwina GIRARD
Contact Person Email
e.girard@ghbs.bzh
Site Name
Centre Francois Baclesse
Department Name
Digestive Oncology
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 Rouen
Department Name
Hepato-gastroenterology and digestive oncology
Principal Investigator Name
Frédéric DI FIORE
Principal Investigator Email
Frederic.Di-Fiore@chu-rouen.fr
Contact Person Name
Frédéric DI FIORE
Contact Person Email
Frederic.Di-Fiore@chu-rouen.fr
Site Name
Capio La Croix Du Sud
Department Name
oncology
Principal Investigator Name
Anne-Pascale LAURENTY
Principal Investigator Email
anne-pascale.laurenty@ramsaysante.fr
Contact Person Name
Anne-Pascale LAURENTY
Site Name
Centre Hospitalier de Sens
Department Name
Médical Oncology
Principal Investigator Name
Huu Thanh LE
Principal Investigator Email
HTLE@ch-sens.fr
Contact Person Name
Huu Thanh LE
Contact Person Email
HTLE@ch-sens.fr
Site Name
Groupe Hospitalier Rance Emeraude
Department Name
Digestive oncology
Principal Investigator Name
Anne-sophie Moussaddaq
Principal Investigator Email
a.moussaddaq@sh-stmalo.fr
Contact Person Name
Anne-sophie Moussaddaq
Contact Person Email
a.moussaddaq@sh-stmalo.fr
Site Name
Clinique Tivoli Ducos
Department Name
oncology
Principal Investigator Name
Valérie COCHIN
Principal Investigator Email
v.cochin@clinique-tivoli.fr
Contact Person Name
Valérie COCHIN
Contact Person Email
v.cochin@clinique-tivoli.fr
Site Name
polyclinique lyon nord
Department Name
Digestive Oncology
Principal Investigator Name
Matthieu SARABI
Principal Investigator Email
m.sarabi@gelmad.fr
Contact Person Name
Matthieu SARABI
Contact Person Email
m.sarabi@gelmad.fr
Site Name
Hoptial La Timone
Department Name
Digestive Oncology
Principal Investigator Name
Laétitia DAHAN
Principal Investigator Email
laetitia.dahan-recherche@ap-hm.fr
Contact Person Name
Laétitia DAHAN
Site Name
Georges-Pompidou European Hospital
Department Name
Digestive Oncology
Principal Investigator Name
aziz zaanan
Principal Investigator Email
aziz.zaanan@aphp.fr
Contact Person Name
aziz zaanan
Contact Person Email
aziz.zaanan@aphp.fr
Site Name
Centre Paul Strauss
Department Name
gastro enterology
Principal Investigator Name
Meher BEN ABDELGHANI
Principal Investigator Email
m.ben-abdelghani@icans.eu
Contact Person Name
Meher BEN ABDELGHANI
Contact Person Email
m.ben-abdelghani@icans.eu
Site Name
Institut Sainte Catherine
Department Name
Digestive Oncology
Principal Investigator Name
May MABRO
Principal Investigator Email
m.mabro@isc84.org
Contact Person Name
May MABRO
Contact Person Email
m.mabro@isc84.org
Site Name
Hopital Prive Jean Mermoz
Department Name
hépato gastro enterology/digestive oncology
Principal Investigator Name
Jérôme DESRAME
Principal Investigator Email
jerome.desrame@orange.fr
Contact Person Name
Jérôme DESRAME
Contact Person Email
jerome.desrame@orange.fr
Site Name
Centre Hospitalier De Cholet
Department Name
oncology
Principal Investigator Name
Thomas DAVIEAU
Principal Investigator Email
thomas.davieau@ch-cholet.fr
Contact Person Name
Thomas DAVIEAU
Contact Person Email
thomas.davieau@ch-cholet.fr
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
gastro enterology
Principal Investigator Name
Morgane CAULET
Principal Investigator Email
m.caulet@chu-tours.fr
Contact Person Name
Morgane CAULET
Contact Person Email
m.caulet@chu-tours.fr
Site Name
Centre De Lutte Contre Le Cancer Eugene Marquis
Department Name
Médical Oncology
Principal Investigator Name
Samuel LE SOURD
Principal Investigator Email
s.lesourd@rennes.unicancer.fr
Contact Person Name
Samuel LE SOURD
Contact Person Email
s.lesourd@rennes.unicancer.fr
Site Name
Institut Paoli Calmettes
Department Name
oncology
Principal Investigator Name
Christelle DE LAFOUCHARDIERE
Principal Investigator Email
delafouchardierec@ipc.unicancer.fr
Contact Person Name
Christelle DE LAFOUCHARDIERE
Site Name
L'Hopital Prive Du Confluent
Department Name
Médical Oncology
Principal Investigator Name
Benjamin LINOT
Principal Investigator Email
benjamin.linot@groupeconfluent.fr
Contact Person Name
Benjamin LINOT
Site Name
Icone
Department Name
Médical Oncology
Principal Investigator Name
William MINA
Principal Investigator Email
wmina@centre-icone.fr
Contact Person Name
William MINA
Contact Person Email
wmina@centre-icone.fr
Site Name
Institut De Cancerologie De Bourgogne
Department Name
hépato gastro enterology/digestive oncology
Principal Investigator Name
Antoine DROUILLARD
Principal Investigator Email
adrouillard@icb-cancer.fr
Contact Person Name
Antoine DROUILLARD
Contact Person Email
adrouillard@icb-cancer.fr
Site Name
Hopital Saint Louis
Department Name
hépato gastro enterology
Principal Investigator Name
Thomas APARICIO
Principal Investigator Email
thomas.aparicio@aphp.fr
Contact Person Name
Thomas APARICIO
Contact Person Email
thomas.aparicio@aphp.fr
Site Name
Centre Hospitalier De La Cote Basque
Department Name
Digestive Oncology
Principal Investigator Name
Franck AUDEMAR
Principal Investigator Email
faudemar@ch-cotebasque.fr
Contact Person Name
Franck AUDEMAR
Contact Person Email
faudemar@ch-cotebasque.fr
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
gastro enterology
Principal Investigator Name
David TOUGERON
Principal Investigator Email
david.tougeron@chu-poitiers.fr
Contact Person Name
David TOUGERON
Contact Person Email
david.tougeron@chu-poitiers.fr
Site Name
Hôpital Franco-Britannique-Fondation Cognacq-Jay
Department Name
oncology
Principal Investigator Name
Benoist CHIBAUDEL
Principal Investigator Email
benoist.chibaudel@cognacq-jay.fr
Contact Person Name
Benoist CHIBAUDEL
Site Name
Centre Hospitalier Lyon Sud
Department Name
gastro enterology
Principal Investigator Name
Chloé VENTURIN
Principal Investigator Email
chloe.venturin01@chu-lyon.fr
Contact Person Name
Chloé VENTURIN
Contact Person Email
chloe.venturin01@chu-lyon.fr
Site Name
CHU Dupuytren
Department Name
oncology
Principal Investigator Name
Frédéric THUILLIER
Principal Investigator Email
frederic.thuillier@chu-limoges.fr
Contact Person Name
Frédéric THUILLIER
Site Name
Clinique Mathilde
Department Name
Médical Oncology
Principal Investigator Name
Romain KOKORIAN
Principal Investigator Email
r.kokorian@vivalto-sante.com
Contact Person Name
Romain KOKORIAN
Contact Person Email
r.kokorian@vivalto-sante.com
Site Name
CENTRE LEONARD DE VINCI
Department Name
oncology
Principal Investigator Name
Natacha STERN-LEDIEU
Principal Investigator Email
nstern@clinique-psv.fr
Contact Person Name
Natacha STERN-LEDIEU
Contact Person Email
nstern@clinique-psv.fr
Site Name
Les Hopitaux Nord-Ouest
Department Name
hépato gastro enterology
Principal Investigator Name
Boris MOREL
Principal Investigator Email
bomorel@hno.fr
Contact Person Name
Boris MOREL
Contact Person Email
bomorel@hno.fr
Site Name
Centre Hospitalier De Pau
Department Name
hépato gastro enterology/oncology
Principal Investigator Name
Juliette THAURY
Principal Investigator Email
juliette.thaury@ch-pau.fr
Contact Person Name
Juliette THAURY
Contact Person Email
juliette.thaury@ch-pau.fr
Site Name
Groupe Hospitalier Diaconesses Croix Saint Simon
Department Name
oncology
Principal Investigator Name
Olivier DUBREUIL
Principal Investigator Email
odubreuil@hopital-dcss.org
Contact Person Name
Olivier DUBREUIL
Contact Person Email
odubreuil@hopital-dcss.org
Site Name
CHRU De Nancy
Department Name
oncology
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
Hopital Memorial France Etats Unis
Department Name
Médical Oncology
Principal Investigator Name
Dingyu XIAO
Principal Investigator Email
dingyu.xiao@ch-stlo.fr
Contact Person Name
Dingyu XIAO
Contact Person Email
dingyu.xiao@ch-stlo.fr
Site Name
Unite De Recherche Clinique HIA Begin
Department Name
gastro enterology
Principal Investigator Name
Julie LAVOLE
Principal Investigator Email
julie.lavole@intradef.gouv.fr
Contact Person Name
Julie LAVOLE
Contact Person Email
julie.lavole@intradef.gouv.fr
Site Name
Centre Hospitalier Prive Saint-Gregoire
Department Name
Médical Oncology
Principal Investigator Name
Hortense DE SAINT BASILE
Principal Investigator Email
hortense.destbasile@icrb.fr
Contact Person Name
Hortense DE SAINT BASILE
Contact Person Email
hortense.destbasile@icrb.fr
Site Name
Centre Antoine Lacassagne
Department Name
Médical Oncology
Principal Investigator Name
Claire JARAUDIAS
Principal Investigator Email
claire.jaraudias@nice.unicancer.fr
Contact Person Name
Claire JARAUDIAS
Site Name
Clinique Belharra
Department Name
Médical Oncology
Principal Investigator Name
Marjorie FAURE
Principal Investigator Email
marjorie.faure@copb.eu
Contact Person Name
Marjorie FAURE
Contact Person Email
marjorie.faure@copb.eu
Site Name
CH Emile Roux
Department Name
oncology
Principal Investigator Name
Kheir Eddine BENMAMMAR
Principal Investigator Email
kheireddine.benmammar@ch-lepuy.fr
Contact Person Name
Kheir Eddine BENMAMMAR
Site Name
Centre Hospitalier Universitaire De Caen Normandie
Department Name
Gastroentérology
Principal Investigator Name
Anne-Laure BIGNON-BRETAGNE
Principal Investigator Email
bignon-al@chu-caen.fr
Contact Person Name
Anne-Laure BIGNON-BRETAGNE
Contact Person Email
bignon-al@chu-caen.fr
Site Name
Centre Hospitalier De Perpignan
Department Name
gastro enterology
Principal Investigator Name
Faiza KHEMISSA AKOUZ
Principal Investigator Email
faiza.khemissa@ch-perpignan.fr
Contact Person Name
Faiza KHEMISSA AKOUZ
Contact Person Email
faiza.khemissa@ch-perpignan.fr
Site Name
Centre Hospitalier Henri Mondor
Department Name
Médical Oncology
Principal Investigator Name
Daniela BURLACU
Principal Investigator Email
d.burlacu@ch-aurillac.fr
Contact Person Name
Daniela BURLACU
Contact Person Email
d.burlacu@ch-aurillac.fr
Site Name
Polyclinique Saint-Come
Department Name
Médical Oncology
Principal Investigator Name
Kais ALDABBAGH
Principal Investigator Email
scr.aldabbagh@stcome.com
Contact Person Name
Kais ALDABBAGH
Contact Person Email
scr.aldabbagh@stcome.com
Site Name
Hopital Cochin Saint Vincent De Paul
Department Name
Gastroentérology/Oncology
Principal Investigator Name
Romain Coriat
Principal Investigator Email
romain.coriat@aphp.fr
Contact Person Name
Romain Coriat
Contact Person Email
romain.coriat@aphp.fr
Site Name
Hospital Foch
Department Name
Médical Oncology
Principal Investigator Name
Asmahane BENMAZIANE
Principal Investigator Email
a.benmaziane@hopital-foch.com
Contact Person Name
Asmahane BENMAZIANE
Contact Person Email
a.benmaziane@hopital-foch.com
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Digestive oncology
Principal Investigator Name
Jean-Philippe METGES
Principal Investigator Email
Jean-philippe.metges@chu-brest.fr
Contact Person Name
Jean-Philippe METGES
Site Name
Institut Godinot
Department Name
Digestive Oncology
Principal Investigator Name
Damien BOTSEN
Principal Investigator Email
damien.botsen@reims.unicancer.fr
Contact Person Name
Damien BOTSEN

Germany

Earliest CTIS Part Ii Submission Date
06-10-2025
Latest Decision Or Authorization Date
04-11-2025
Processing Time Days
29
Number Of Sites
8
Number Of Participants
108

Sites

Site Name
KEM I Evang. Kliniken Essen-Mitte gGmbH
Department Name
Klinik für Internistische Onkologie/Hämatologie
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
Site Name
Universitaet Leipzig
Department Name
Universitäres Krebszentrum Leipzig (UCCL)
Principal Investigator Name
Gertraud Stocker
Contact Person Name
Gertraud Stocker
Site Name
Klinikum Rechts Der Isar Der Technischen Universitat Munchen
Department Name
3. Medizinishce Klinik/hämatologie und Onkologie
Principal Investigator Name
Sylvie Lorenzen
Principal Investigator Email
sylvie.lorenzen@mri.tum.de
Contact Person Name
Sylvie Lorenzen
Contact Person Email
sylvie.lorenzen@mri.tum.de
Site Name
Haematologisch Onkologische Praxis Eppendorf
Department Name
n.a.
Principal Investigator Name
Alexander Stein
Principal Investigator Email
stein@hope-hamburg.de
Contact Person Name
Alexander Stein
Contact Person Email
stein@hope-hamburg.de
Site Name
Krankenhaus Nordwest GmbH
Department Name
Institut für Klinisch-Onkologische Forschung
Principal Investigator Name
Thorsten Götze
Principal Investigator Email
goetze.thorsten@khnw.de
Contact Person Name
Thorsten Götze
Contact Person Email
goetze.thorsten@khnw.de
Site Name
Rostock University Medical Center
Department Name
Division of Internal Medicine, Medical Clinic III - Hematology, Oncology and Palliative Medicine
Principal Investigator Name
Hartmut Gläser
Principal Investigator Email
Hartmut.glaeser@med.uni-rostock.de
Contact Person Name
Hartmut Gläser
Site Name
Klinikum Chemnitz gGmbH
Department Name
Internal Medicine III
Principal Investigator Name
Jack Chafic Chater Cure
Principal Investigator Email
j.chater@skc.de
Contact Person Name
Jack Chafic Chater Cure
Contact Person Email
j.chater@skc.de
Site Name
Universitaetsklinikum Jena KöR
Department Name
Klinik für Innere Medizin II
Principal Investigator Name
Udo Lindig
Principal Investigator Email
Udo.lindig@med.uni-jena.de
Contact Person Name
Udo Lindig
Contact Person Email
Udo.lindig@med.uni-jena.de

Spain

Earliest CTIS Part Ii Submission Date
16-12-2025
Latest Decision Or Authorization Date
30-03-2026
Processing Time Days
104
Number Of Sites
14
Number Of Participants
40

Sites

Site Name
Complejo Hospitalario Universitario De Ourense
Department Name
Oncology
Principal Investigator Name
Ana Fernandez
Principal Investigator Email
afm1003@hotmail.com
Contact Person Name
Ana Fernandez
Contact Person Email
afm1003@hotmail.com
Site Name
Hospital Universitario De Salamanca
Department Name
Oncology
Principal Investigator Name
Rosario Vidal
Principal Investigator Email
mrvidal@saludcastillayleon.es
Contact Person Name
Rosario Vidal
Contact Person Email
mrvidal@saludcastillayleon.es
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Oncology
Principal Investigator Name
Fernando Rivera
Principal Investigator Email
fernando.rivera@scasalud.es
Contact Person Name
Fernando Rivera
Contact Person Email
fernando.rivera@scasalud.es
Site Name
Hospital Clinic De Barcelona
Department Name
Oncology
Principal Investigator Name
Tamara Sauri
Principal Investigator Email
sauri@clinic.cat
Contact Person Name
Tamara Sauri
Contact Person Email
sauri@clinic.cat
Site Name
Consorci Sanitari Integral
Department Name
Oncology
Principal Investigator Name
Marc Diez
Principal Investigator Email
mdiezg@csi.cat
Contact Person Name
Marc Diez
Contact Person Email
mdiezg@csi.cat
Site Name
Hospital Universitario De Navarra
Department Name
Oncology
Principal Investigator Name
Virginia Arrazubi
Principal Investigator Email
virginia.arrazubi.arrula@navarra.es
Contact Person Name
Virginia Arrazubi
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Oncology
Principal Investigator Name
Tania Fleitas
Principal Investigator Email
tfleitask@gmail.com
Contact Person Name
Tania Fleitas
Contact Person Email
tfleitask@gmail.com
Site Name
Consorcio Hospital General Universitario De Valencia
Department Name
Oncology
Principal Investigator Name
Mireia Gil
Principal Investigator Email
Gil_mir@gva.es
Contact Person Name
Mireia Gil
Contact Person Email
Gil_mir@gva.es
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Oncology
Principal Investigator Name
Nieves Martinez
Contact Person Name
Nieves Martinez
Site Name
Hospital Universitario Regional De Malaga
Department Name
Oncology
Principal Investigator Name
Inmaculada Ales
Principal Investigator Email
inales@hotmail.com
Contact Person Name
Inmaculada Ales
Contact Person Email
inales@hotmail.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology
Principal Investigator Name
Eduardo Teran
Principal Investigator Email
eduardoteran@vhio.net
Contact Person Name
Eduardo Teran
Contact Person Email
eduardoteran@vhio.net
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Oncology
Principal Investigator Name
Federico Longo
Principal Investigator Email
fedelongomunoz@hotmail.com
Contact Person Name
Federico Longo
Contact Person Email
fedelongomunoz@hotmail.com
Site Name
Hospital Universitario Reina Sofia
Department Name
Oncology
Principal Investigator Name
Raquel Serrano
Principal Investigator Email
rsblanch@hotmail.com
Contact Person Name
Raquel Serrano
Contact Person Email
rsblanch@hotmail.com
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Oncology
Principal Investigator Name
Aitana Calvo
Principal Investigator Email
aitanacalvo@hotmail.com
Contact Person Name
Aitana Calvo
Contact Person Email
aitanacalvo@hotmail.com

Sponsor

Primary sponsor

Full Name
Fondation Franc.Cancerologie Digestive
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
France

Contract research organisations

Name
Frankfurter Institut Fuer Klinische Krebsforschung IKF GmbH
Responsibilities
CRO for germany (project mangement and monitoring)

Third parties

  • {"country":"France","full_name":"CRB EPIGENETEC","duties_or_roles":"sample archiving and Laboratory analysis","organisation_type":"Health care"}
  • {"country":"France","full_name":"Eurofins Clinical Trial Supplies France","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Frankfurter Institut Fuer Klinische Krebsforschung IKF GmbH","duties_or_roles":"CRO for germany (project mangement and monitoring)","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
FRUZAQLA 5 mg hard capsules
Active Substance
FRUQUINTINIB
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
Oral
Authorisation Status
Authorised (marketingAuthNumber: EU/1/24/1827/002)
Dose Levels
5 mg hard capsule
Maximum Dose
5 mg (maxDailyDoseAmount)
Investigational Product Name
FRUZAQLA 1 mg hard capsules
Active Substance
FRUQUINTINIB
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
Oral
Authorisation Status
Authorised (marketingAuthNumber: EU/1/24/1827/001)
Dose Levels
1 mg hard capsule
Maximum Dose
5 mg (maxDailyDoseAmount reported for product group)
Investigational Product Name
Lonsurf 15 mg/6.14 mg film-coated tablets
Active Substance
TRIFLURIDINE, TIPIRACIL HYDROCHLORIDE
Modality
Small molecule
Routes Of Administration
ORAL
Route
Oral
Authorisation Status
Authorised (marketingAuthNumber: EU/1/16/1096/001)
Dose Levels
15 mg/6.14 mg film-coated tablet
Maximum Dose
35 mg/m2 (maxDailyDoseAmount reported)
Investigational Product Name
Lonsurf 20 mg/8.19 mg film-coated tablets
Active Substance
TRIFLURIDINE, TIPIRACIL HYDROCHLORIDE
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
Oral
Authorisation Status
Authorised (marketingAuthNumber: EU/1/16/1096/006)
Dose Levels
20 mg/8.19 mg film-coated tablet
Maximum Dose
35 mg/m2 (maxDailyDoseAmount reported)
Combination Treatment
Yes

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