Clinical trial • Phase I • Oncology
Everolimus for Hepatocellular carcinoma
Phase I trial of Everolimus for Hepatocellular carcinoma.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Hepatocellular carcinoma
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 22-08-2024
- First CTIS Authorization Date
- 16-12-2024
Trial design
Everolimus (mentioned in public title as combination; dose and schedule not specified)-controlled Phase I trial across 19 sites in Spain, Germany, France.
- Comparator
- Everolimus (mentioned in public title as combination; dose and schedule not specified)
- Target Sample Size
- 154
- Trial Duration For Participant
- 1538
Eligibility
Recruits 154 Vulnerable population selected; no details provided on consent or assent handling..
- Vulnerable Population
- Vulnerable population selected; no details provided on consent or assent handling.
Recruitment
- Planned Sample Size
- 154
- Recruitment Window Months
- 50
Geography
- Total Number Of Sites
- 19
- Total Number Of Participants
- 154
Spain
- Earliest CTIS Part Ii Submission Date
- 02-12-2024
- Latest Decision Or Authorization Date
- 15-01-2026
- Processing Time Days
- 409
- Number Of Sites
- 7
- Number Of Participants
- 56
Sites
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Medical Oncology
- Principal Investigator Name
- Bernard Doger de Speville
- Principal Investigator Email
- bernard.doger@startmadrid.com
- Contact Person Name
- Bernard Doger de Speville
- Contact Person Email
- bernard.doger@startmadrid.com
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Medical Oncology
- Principal Investigator Name
- Maria Elisa Reig Monzón
- Principal Investigator Email
- mreig1@clinic.cat
- Contact Person Name
- Maria Elisa Reig Monzón
- Contact Person Email
- mreig1@clinic.cat
- Site Name
- Hospital Universitario Miguel Servet
- Department Name
- Medical Oncology
- Principal Investigator Name
- Roberto Pazo Cid
- Principal Investigator Email
- rpazo@salud.aragon.es
- Contact Person Name
- Roberto Pazo Cid
- Contact Person Email
- rpazo@salud.aragon.es
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Medical Oncology
- Principal Investigator Name
- Jaume Capdevila Castillon
- Principal Investigator Email
- jcapdevila@vhio.net
- Contact Person Name
- Jaume Capdevila Castillon
- Contact Person Email
- jcapdevila@vhio.net
- Site Name
- Hospital Universitario La Paz
- Department Name
- Medical Oncology
- Principal Investigator Name
- Jaime Feliu Batlle
- Principal Investigator Email
- jaime.feliu@uam.es
- Contact Person Name
- Jaime Feliu Batlle
- Contact Person Email
- jaime.feliu@uam.es
- Site Name
- Hospital General Universitario De Valencia
- Department Name
- Medical Oncology
- Principal Investigator Name
- Miriam Lobo de Mena
- Principal Investigator Email
- lobo_mir@gva.es
- Contact Person Name
- Miriam Lobo de Mena
- Contact Person Email
- lobo_mir@gva.es
Germany
- Earliest CTIS Part Ii Submission Date
- 23-10-2024
- Latest Decision Or Authorization Date
- 15-01-2026
- Processing Time Days
- 449
- Number Of Sites
- 3
- Number Of Participants
- 17
Sites
- Site Name
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
- Department Name
- I. Medical Department
- Principal Investigator Name
- Peter Galle
- Principal Investigator Email
- Peter.galle@unimedizinmainz.de
- Contact Person Name
- Peter Galle
- Contact Person Email
- Peter.galle@unimedizinmainz.de
- Site Name
- Universitaetsklinikum Leipzig AöR
- Department Name
- Medicine II, Hepatology
- Principal Investigator Name
- Florian van Boemmel
- Principal Investigator Email
- Florian.vanBoemmel@medizin.uni-leipzig.de
- Contact Person Name
- Florian van Boemmel
- Contact Person Email
- Florian.vanBoemmel@medizin.uni-leipzig.de
- Site Name
- Universitaetsklinikum Heidelberg AöR
- Department Name
- Medical Oncology
- Principal Investigator Name
- Christoph Springfeld
- Principal Investigator Email
- christoph.springfeld@med.uniheidelberg.de
- Contact Person Name
- Christoph Springfeld
- Contact Person Email
- christoph.springfeld@med.uniheidelberg.de
France
- Earliest CTIS Part Ii Submission Date
- 12-09-2024
- Latest Decision Or Authorization Date
- 14-01-2026
- Processing Time Days
- 489
- Number Of Sites
- 9
- Number Of Participants
- 81
Sites
- Site Name
- Centre Hospitalier Universitaire De Poitiers
- Department Name
- Medical Oncology
- 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
- Institut Gustave Roussy
- Department Name
- Early Drug Development Department
- Principal Investigator Name
- Cristina Smolenschi
- Principal Investigator Email
- cristina.smolenschi@gustaveroussy.fr
- Contact Person Name
- Cristina Smolenschi
- Contact Person Email
- cristina.smolenschi@gustaveroussy.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Hepato-gastroenterology
- Principal Investigator Name
- Yann Touchefeu
- Principal Investigator Email
- yann.touchefeu@chu-nantes.fr
- Contact Person Name
- Yann Touchefeu
- Contact Person Email
- yann.touchefeu@chu-nantes.fr
- Site Name
- Centr Georges Francois Leclerc
- Department Name
- Medical Oncology
- Principal Investigator Name
- François Ghiringhelli
- Principal Investigator Email
- fghiringhelli@cgfl.fr
- Contact Person Name
- François Ghiringhelli
- Contact Person Email
- fghiringhelli@cgfl.fr
- Site Name
- Centre De Lutte Contre Le Cancer Eugene Marquis
- Department Name
- Medical Oncology
- Principal Investigator Name
- Julien Edeline
- Principal Investigator Email
- j.edeline@rennes.unicancer.fr
- Contact Person Name
- Julien Edeline
- Contact Person Email
- j.edeline@rennes.unicancer.fr
- Site Name
- Les Hopitaux Universitaires De Strasbourg
- Department Name
- Hepato-gastroenterology and endoscopy
- Principal Investigator Name
- François Habersetzer
- Principal Investigator Email
- francois.habersetzer@chru-strasbourg.fr
- Contact Person Name
- François Habersetzer
- Contact Person Email
- francois.habersetzer@chru-strasbourg.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
- Assistance Publique Hopitaux De Paris
- Department Name
- Hepatology
- Principal Investigator Name
- Jean-Charles Nault
- Principal Investigator Email
- Jean-charles.nault@jvr.aphp.fr
- Contact Person Name
- Jean-Charles Nault
- Contact Person Email
- Jean-charles.nault@jvr.aphp.fr
- Site Name
- Oncopole Claudius Regaud
- Department Name
- Medical Digestive Oncology
- Principal Investigator Name
- Nadim Fares
- Principal Investigator Email
- fares.nadim@iuct-toulouse.fr
- Contact Person Name
- Nadim Fares
- Contact Person Email
- fares.nadim@iuct-toulouse.fr
Sponsor
Primary sponsor
- Full Name
- Captor Therapeutics S.A.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Poland
Investigational products
- Investigational Product Name
- CT-01
- Investigational Product Name
- Everolimus
- Active Substance
- Everolimus
- Modality
- Small molecule
- Combination Treatment
- Yes
Related trials
Other published trials that may interest you.