Clinical trial • Phase IV • Oncology|Gastroenterology

Gembrax for Metastatic pancreatic adenocarcinoma

Phase IV trial of Gembrax for Metastatic pancreatic adenocarcinoma. Folfirinox alone; dose and schedule not specified-controlled. 162 participants.

Overview

Trial Therapeutic Area
Oncology|Gastroenterology
Trial Disease
Metastatic pancreatic adenocarcinoma
Trial Stage
Phase IV
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
19-07-2024
First CTIS Authorization Date
19-09-2024

Trial design

Folfirinox alone; dose and schedule not specified-controlled Phase IV trial in France.

Comparator
Folfirinox alone; dose and schedule not specified
Target Sample Size
162

Recruitment

Planned Sample Size
162
Recruitment Window Months
68

Geography

Total Number Of Sites
8
Total Number Of Participants
162

France

Earliest CTIS Part Ii Submission Date
03-10-2023
Latest Decision Or Authorization Date
08-12-2025
Processing Time Days
797
Number Of Sites
8
Number Of Participants
162

Sites

Site Name
Centr Georges Francois Leclerc
Department Name
Côte d'or
Contact Person Name
François Ghiringhelli
Contact Person Email
FGhiringhelli@cgfl.fr
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Hérault
Contact Person Name
Eric Assénat
Contact Person Email
e-assenat@chu-montpellier.fr
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Isère
Contact Person Name
Gaêl Roth
Contact Person Email
GRoth@chu-grenoble.fr
Site Name
Centre Catalan D'oncologie
Department Name
Pyrénées-orientales
Contact Person Name
Kara Kara Slimane
Site Name
Centre Hospitalier De Perpignan
Department Name
Pyrénées-orientales
Contact Person Name
Faïza Khemissa
Contact Person Email
faiza.khemissa@ch-perpignan.fr
Site Name
Institut Godinot
Department Name
Marne
Contact Person Name
Damien Botsen
Contact Person Email
dbotsen@chu-reims.fr
Site Name
Centre Hospitalier Universitaire De Saint Etienne
Department Name
Loire
Contact Person Name
Nicolas Williet
Site Name
Institut Regional Du Cancer De Montpellier
Department Name
Hérault
Contact Person Name
Fabienne Portalès

Sponsor

Primary sponsor

Full Name
Institut Regional Du Cancer De Montpellier
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
France

Investigational products

Investigational Product Name
Gembrax
Modality
Small molecule
Investigational Product Name
Folfirinox
Modality
Small molecule
Combination Treatment
Yes

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