Clinical trial • Phase III • Oncology
KIN-2787 for BRAF and/or NRAS mutation-positive solid tumours
Phase III trial of KIN-2787 for BRAF and/or NRAS mutation-positive solid tumours. 321 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- BRAF and/or NRAS mutation-positive solid tumours
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 02-10-2024
- First CTIS Authorization Date
- 15-10-2024
Trial design
Phase III trial across 27 sites in France, Spain, Italy and others.
- Target Sample Size
- 321
Eligibility
Recruits 321 Vulnerable population not selected; no special consent or assent handling is described in the provided record..
- Vulnerable Population
- Vulnerable population not selected; no special consent or assent handling is described in the provided record.
Recruitment
- Planned Sample Size
- 321
- Recruitment Window Months
- 69
Geography
- Total Number Of Sites
- 27
- Total Number Of Participants
- 182
France
- Earliest CTIS Part Ii Submission Date
- 16-10-2024
- Latest Decision Or Authorization Date
- 18-09-2025
- Processing Time Days
- 337
- Number Of Sites
- 12
- Number Of Participants
- 106
Sites
- Site Name
- Institut Bergonie
- Department Name
- Medical Oncology
- Principal Investigator Name
- Antoine Italiano
- Principal Investigator Email
- a.italiano@bordeaux.unicancer.fr
- Contact Person Name
- Antoine Italiano
- Contact Person Email
- a.italiano@bordeaux.unicancer.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Oncology Department
- Principal Investigator Name
- Stephane Dalle
- Principal Investigator Email
- stephane.dalle@chu-lyon.fr
- Contact Person Name
- Stephane Dalle
- Contact Person Email
- stephane.dalle@chu-lyon.fr
- Site Name
- Centre Hospitalier Universitaire De Nice
- Department Name
- Oncology
- Principal Investigator Name
- Henri Montaudié
- Principal Investigator Email
- montaudie.h@chu-nice.fr
- Contact Person Name
- Henri Montaudié
- Contact Person Email
- montaudie.h@chu-nice.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Medical Oncology
- Principal Investigator Name
- Jeanne Chen
- Principal Investigator Email
- jeanne.chen@chu-nantes.fr
- Contact Person Name
- Jeanne Chen
- Contact Person Email
- jeanne.chen@chu-nantes.fr
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- Oncology Department
- Principal Investigator Name
- Caroline Gaudy
- Principal Investigator Email
- caroline.gaudy@ap-hm.fr
- Contact Person Name
- Caroline Gaudy
- Contact Person Email
- caroline.gaudy@ap-hm.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- Oncology
- Principal Investigator Name
- David Planchard
- Principal Investigator Email
- david.planchard@gustaveroussy.fr
- Contact Person Name
- David Planchard
- Contact Person Email
- david.planchard@gustaveroussy.fr
- Site Name
- Centre Hospitalier Universitaire De Poitiers
- Department Name
- Oncology Department
- Principal Investigator Name
- Nicolas Isambert
- Principal Investigator Email
- Nicolas.ISAMBERT@chu-poitiers.fr
- Contact Person Name
- Nicolas Isambert
- Contact Person Email
- Nicolas.ISAMBERT@chu-poitiers.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Oncology Department
- Principal Investigator Name
- Anthony Turpin
- Principal Investigator Email
- Anthony.TURPIN@chu-lille.fr
- Contact Person Name
- Anthony Turpin
- Contact Person Email
- Anthony.TURPIN@chu-lille.fr
- Site Name
- Centre Leon Berard
- Department Name
- Medical Oncology
- Principal Investigator Name
- Philippe Cassier
- Principal Investigator Email
- philippe.cassier@lyon.unicancer.fr
- Contact Person Name
- Philippe Cassier
- Contact Person Email
- philippe.cassier@lyon.unicancer.fr
- Site Name
- Oncopole Claudius Regaud
- Department Name
- Oncology Department
- Principal Investigator Name
- Cécile Pages
- Principal Investigator Email
- PagesLaurent.Cecile@iuct-oncopole.fr
- Contact Person Name
- Cécile Pages
- Contact Person Email
- PagesLaurent.Cecile@iuct-oncopole.fr
- Site Name
- Centre Francois Baclesse
- Department Name
- Oncology Department
- Principal Investigator Name
- Andreea Stephan
- Principal Investigator Email
- a.stefan@baclesse.unicancer.fr
- Contact Person Name
- Andreea Stephan
- Contact Person Email
- a.stefan@baclesse.unicancer.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Oncology Department
- Principal Investigator Name
- Celeste Lebbé
- Principal Investigator Email
- celeste.lebbe@aphp.fr
- Contact Person Name
- Celeste Lebbé
- Contact Person Email
- celeste.lebbe@aphp.fr
Spain
- Earliest CTIS Part Ii Submission Date
- 11-10-2024
- Latest Decision Or Authorization Date
- 08-04-2026
- Processing Time Days
- 544
- Number Of Sites
- 10
- Number Of Participants
- 46
Sites
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Medical Oncology
- Principal Investigator Name
- Antonio Calles Blanco
- Principal Investigator Email
- antonio.calles@live.com
- Contact Person Name
- Antonio Calles Blanco
- Contact Person Email
- antonio.calles@live.com
- Site Name
- Hospital Universitari Dexeus Grupo Quironsalud
- Department Name
- Oncology Department
- Principal Investigator Name
- María González Cao
- Principal Investigator Email
- mgonzalezcao@oncorosell.com
- Contact Person Name
- María González Cao
- Contact Person Email
- mgonzalezcao@oncorosell.com
- Site Name
- Complejo Hospitalario Universitario Insular Materno Infantil
- Department Name
- Medical Oncology
- Principal Investigator Name
- Delvys Rodríguez Abreu
- Principal Investigator Email
- drodabr@gobiernodecanarias.org
- Contact Person Name
- Delvys Rodríguez Abreu
- Contact Person Email
- drodabr@gobiernodecanarias.org
- Site Name
- Hospital Universitario Quironsalud Madrid
- Department Name
- Oncology Department
- Principal Investigator Name
- Valentina Boni
- Principal Investigator Email
- vboni@nextoncology.eu
- Contact Person Name
- Valentina Boni
- Contact Person Email
- vboni@nextoncology.eu
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Oncology Department
- Principal Investigator Name
- Ana María Arance Fernández
- Principal Investigator Email
- AMARANCE@clinic.cat
- Contact Person Name
- Ana María Arance Fernández
- Contact Person Email
- AMARANCE@clinic.cat
- Site Name
- Hospital Universitario Regional De Malaga
- Department Name
- Oncology Department
- Principal Investigator Name
- Miguel Ángel Berciano Guerrero
- Principal Investigator Email
- migueberci@gmail.com
- Contact Person Name
- Miguel Ángel Berciano Guerrero
- Contact Person Email
- migueberci@gmail.com
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- Medical Oncology
- Principal Investigator Name
- Valentina Gambardella
- Principal Investigator Email
- valen.gambardella@gmail.com
- Contact Person Name
- Valentina Gambardella
- Contact Person Email
- valen.gambardella@gmail.com
- Site Name
- Hospital Universitario Virgen De La Macarena
- Department Name
- Oncology Department
- Principal Investigator Name
- De la Cruz Merino Luis
- Principal Investigator Email
- luis.cruz.sspa@juntadeandalucia.es
- Contact Person Name
- De la Cruz Merino Luis
- Contact Person Email
- luis.cruz.sspa@juntadeandalucia.es
- Site Name
- Hospital Universitario Hm Sanchinarro
- Department Name
- Oncology Department
- Principal Investigator Name
- Irene Moreno Candilejo
- Principal Investigator Email
- irene.moreno@startmadrid.com
- Contact Person Name
- Irene Moreno Candilejo
- Contact Person Email
- irene.moreno@startmadrid.com
- Site Name
- Hospital General Universitario De Valencia
- Department Name
- Oncology Department
- Principal Investigator Name
- Alfonso Berrocal Jaime
- Principal Investigator Email
- berrocal.alf@gmail.com
- Contact Person Name
- Alfonso Berrocal Jaime
- Contact Person Email
- berrocal.alf@gmail.com
Italy
- Earliest CTIS Part Ii Submission Date
- 21-02-2025
- Latest Decision Or Authorization Date
- 18-09-2025
- Processing Time Days
- 209
- Number Of Sites
- 2
- Number Of Participants
- 12
Sites
- Site Name
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Department Name
- Medical Oncology
- Principal Investigator Name
- Paolo A. Ascierto
- Principal Investigator Email
- p.ascierto@istitutotumori.na.it
- Contact Person Name
- Paolo A. Ascierto
- Contact Person Email
- p.ascierto@istitutotumori.na.it
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- Medical Oncology
- Principal Investigator Name
- Matteo Duca
- Principal Investigator Email
- matteo.duca@istitutotumori.mi.it
- Contact Person Name
- Matteo Duca
- Contact Person Email
- matteo.duca@istitutotumori.mi.it
Germany
- Earliest CTIS Part Ii Submission Date
- 15-12-2025
- Latest Decision Or Authorization Date
- 22-12-2025
- Processing Time Days
- 7
- Number Of Sites
- 3
- Number Of Participants
- 18
Sites
- Site Name
- Elbe Kliniken Stade-Buxtehude gGmbH
- Department Name
- Dermatology
- Principal Investigator Name
- Peter Mohr
- Principal Investigator Email
- peter.mohr@elbekliniken.de
- Contact Person Name
- Peter Mohr
- Contact Person Email
- peter.mohr@elbekliniken.de
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- Dermatology
- Principal Investigator Name
- Dirk Schadendorf
- Principal Investigator Email
- dirk.schadendorf@uk-essen.de
- Contact Person Name
- Dirk Schadendorf
- Contact Person Email
- dirk.schadendorf@uk-essen.de
- Site Name
- University Medical Center Hamburg-Eppendorf
- Department Name
- Dermatology
- Principal Investigator Name
- Christoffer Gebhardt
- Principal Investigator Email
- ch.gebhardt@uke.de
- Contact Person Name
- Christoffer Gebhardt
- Contact Person Email
- ch.gebhardt@uke.de
Sponsor
Primary sponsor
- Full Name
- Pierre Fabre Medicament
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- KIN-2787
- Modality
- Small molecule
- Routes Of Administration
- oral
- Route
- oral
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