Clinical trial • Phase I • Oncology
bevacizumab for Advanced solid tumours | Non-small cell lung cancer | Head and neck squamous cell carcinoma | Gastric/gastroesophageal junction adenocarcinoma | Colorectal cancer | Renal cell carcinoma
Phase I trial of bevacizumab for Advanced solid tumours | Non-small cell lung cancer | Head and neck squamous cell carcinoma | Gastric/gastroesophageal ju…
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced solid tumours | Non-small cell lung cancer | Head and neck squamous cell carcinoma | Gastric/gastroesophageal junction adenocarcinoma | Colorectal cancer | Renal cell carcinoma
- Trial Stage
- Phase I
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 14-06-2024
- First CTIS Authorization Date
- 11-07-2024
Trial design
Phase I trial across 24 sites in Germany, France, Spain and others.
- Target Sample Size
- 323
Eligibility
Recruits 323 Vulnerable population selected (isVulnerablePopulationSelected=true); no additional information on consent or assent handling is provided in the record..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected=true); no additional information on consent or assent handling is provided in the record.
Recruitment
- Planned Sample Size
- 323
- Recruitment Window Months
- 57
Geography
- Total Number Of Sites
- 24
- Total Number Of Participants
- 177
Germany
- Earliest CTIS Part Ii Submission Date
- 22-03-2024
- Latest Decision Or Authorization Date
- 19-07-2024
- Processing Time Days
- 119
- Number Of Sites
- 3
- Number Of Participants
- 12
Sites
- Site Name
- University Hospital Cologne AöR
- Department Name
- Innere Medizin I
- Principal Investigator Name
- Jürgen Wolf
- Principal Investigator Email
- juergen.wolf@uk-koeln.de
- Contact Person Name
- Jürgen Wolf
- Contact Person Email
- juergen.wolf@uk-koeln.de
- Site Name
- Universitaetsklinikum Giessen und Marburg GmbH
- Department Name
- Medizinische Klinik IV Organonkologie
- Principal Investigator Name
- Thomas Wehler
- Principal Investigator Email
- Thomas.Wehler@innere.med.uni-giessen.de
- Contact Person Name
- Thomas Wehler
- Contact Person Email
- Thomas.Wehler@innere.med.uni-giessen.de
- Site Name
- Charite Research Organisation GmbH (Hamato Onkologische Phase-I Unit)
- Department Name
- Hamato Onkologische Phase-I Unit
- Principal Investigator Name
- Sebastian Ochsenreither
- Principal Investigator Email
- sebastian.ochsenreither@charite.de
- Contact Person Name
- Sebastian Ochsenreither
- Contact Person Email
- sebastian.ochsenreither@charite.de
France
- Earliest CTIS Part Ii Submission Date
- 22-03-2024
- Latest Decision Or Authorization Date
- 19-07-2024
- Processing Time Days
- 119
- Number Of Sites
- 7
- Number Of Participants
- 90
Sites
- Site Name
- Centr Georges Francois Leclerc
- Department Name
- Oncologie Medicale
- Principal Investigator Name
- Francois Ghiringhelli
- Principal Investigator Email
- fghiringhelli@cgfl.fr
- Contact Person Name
- Francois Ghiringhelli
- Contact Person Email
- fghiringhelli@cgfl.fr
- Site Name
- Institut De Cancerologie De L Ouest
- Department Name
- Oncology
- Principal Investigator Name
- Judith Raimbourg
- Principal Investigator Email
- judith.raimbourg@ico.unicancer.fr
- Contact Person Name
- Judith Raimbourg
- Contact Person Email
- judith.raimbourg@ico.unicancer.fr
- Site Name
- Institut Bergonie
- Department Name
- Medical Oncology
- Principal Investigator Name
- Sophie COUSIN
- Principal Investigator Email
- s.cousin@bordeaux.unicancer.fr
- Contact Person Name
- Sophie COUSIN
- Contact Person Email
- s.cousin@bordeaux.unicancer.fr
- Site Name
- Centre Leon Berard
- Department Name
- Oncologie Médicale
- Principal Investigator Name
- Aurelie Swalduz
- Principal Investigator Email
- aurelie.swalduz@lyon.unicancer.fr
- Contact Person Name
- Aurelie Swalduz
- Contact Person Email
- aurelie.swalduz@lyon.unicancer.fr
- Site Name
- Centre Antoine Lacassagne
- Department Name
- Oncologie
- Principal Investigator Name
- Esma Saada-Bouzid
- Principal Investigator Email
- esma.saada-bouzid@nice.unicancer.fr
- Contact Person Name
- Esma Saada-Bouzid
- Contact Person Email
- esma.saada-bouzid@nice.unicancer.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- Service De Gastro-Entérologie
- Principal Investigator Name
- Antoine Hollebecque
- Principal Investigator Email
- antoine.hollebecque@gustaveroussy.fr
- Contact Person Name
- Antoine Hollebecque
- Contact Person Email
- antoine.hollebecque@gustaveroussy.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Service dOncologie medicale – Unite dOncologie thoracique
- 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
Spain
- Earliest CTIS Part Ii Submission Date
- 22-03-2024
- Latest Decision Or Authorization Date
- 11-07-2024
- Processing Time Days
- 111
- Number Of Sites
- 11
- Number Of Participants
- 55
Sites
- Site Name
- Hospital Universitario Hm Sanchinarro
- Department Name
- Oncología
- Principal Investigator Name
- María De Miguel Luken
- Principal Investigator Email
- maria.demiguel@startmadrid.com
- Contact Person Name
- María De Miguel Luken
- Contact Person Email
- maria.demiguel@startmadrid.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncología Médica
- Principal Investigator Name
- Enriqueta Felip Font
- Principal Investigator Email
- efelip@vhio.net
- Contact Person Name
- Enriqueta Felip Font
- Contact Person Email
- efelip@vhio.net
- Site Name
- Hospital Universitario De Jaen
- Department Name
- Oncología Médica
- Principal Investigator Name
- Ana Laura Ortega Granados
- Principal Investigator Email
- analaura.ortega.sspa@juntadeandalucia.es
- Contact Person Name
- Ana Laura Ortega Granados
- Contact Person Email
- analaura.ortega.sspa@juntadeandalucia.es
- Site Name
- Hospital Universitario Virgen De La Macarena
- Department Name
- Oncología Médica
- Principal Investigator Name
- David Vicente Baz
- Principal Investigator Email
- David.Vbaz@Gmail.Com
- Contact Person Name
- David Vicente Baz
- Contact Person Email
- David.Vbaz@Gmail.Com
- Site Name
- Institut Catala D'oncologia
- Department Name
- Oncología Médica
- Principal Investigator Name
- Cinta Hierro Carbó
- Principal Investigator Email
- chierro@iconcologia.net
- Contact Person Name
- Cinta Hierro Carbó
- Contact Person Email
- chierro@iconcologia.net
- Site Name
- Hospital Universitario Fundacion Alcorcon
- Department Name
- Oncología
- Principal Investigator Name
- Elisabeth Jimenez Aguilar
- Principal Investigator Email
- elisabeth.jimenez@salud.madrid.org
- Contact Person Name
- Elisabeth Jimenez Aguilar
- Contact Person Email
- elisabeth.jimenez@salud.madrid.org
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Oncología Medica
- Principal Investigator Name
- Ana Landa Magdalena
- Principal Investigator Email
- alandam@unav.es
- Contact Person Name
- Ana Landa Magdalena
- Contact Person Email
- alandam@unav.es
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Oncología Medica
- Principal Investigator Name
- Aitana Calvo Ferrándiz
- Principal Investigator Email
- aitanacalvo@hotmail.com
- Contact Person Name
- Aitana Calvo Ferrándiz
- Contact Person Email
- aitanacalvo@hotmail.com
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Oncología Medica
- Principal Investigator Name
- Luis Paz-Ares Rodríguez
- Principal Investigator Email
- Lpazaresr@Seom.Org
- Contact Person Name
- Luis Paz-Ares Rodríguez
- Contact Person Email
- Lpazaresr@Seom.Org
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Oncología
- Principal Investigator Name
- Ivan Victoria Ruiz
- Principal Investigator Email
- ivictori@recerca.clinic.cat
- Contact Person Name
- Ivan Victoria Ruiz
- Contact Person Email
- ivictori@recerca.clinic.cat
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Oncología
- Principal Investigator Name
- Bernard Doger De Speville Uribe
- Principal Investigator Email
- bernard.doger@startmadrid.com
- Contact Person Name
- Bernard Doger De Speville Uribe
- Contact Person Email
- bernard.doger@startmadrid.com
Poland
- Earliest CTIS Part Ii Submission Date
- 22-03-2024
- Latest Decision Or Authorization Date
- 04-08-2024
- Processing Time Days
- 135
- Number Of Sites
- 3
- Number Of Participants
- 20
Sites
- Site Name
- Med Polonia Sp. z o.o.
- Department Name
- Oncology
- Principal Investigator Name
- Rodryg Ramlau
- Principal Investigator Email
- rramlau@gmail.com
- Contact Person Name
- Rodryg Ramlau
- Contact Person Email
- rramlau@gmail.com
- Site Name
- Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu
- Department Name
- Oddzial Onkologiczny z Pododdzialem Dziennej Chemioterapii
- Principal Investigator Name
- Kamil Kuc
- Principal Investigator Email
- kkuc@wszp.pl
- Contact Person Name
- Kamil Kuc
- Contact Person Email
- kkuc@wszp.pl
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Department Name
- Oddzial Badan Wczesnych Faz
- Principal Investigator Name
- Iwona Lugowska
- Principal Investigator Email
- Iwona.Lugowska@pib-nio.pl
- Contact Person Name
- Iwona Lugowska
- Contact Person Email
- Iwona.Lugowska@pib-nio.pl
Sponsor
Primary sponsor
- Full Name
- AbbVie Deutschland GmbH & Co. KG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Investigational products
- Investigational Product Name
- ABBV-400
- First In Human
- Yes
- Investigational Product Name
- bevacizumab
- Active Substance
- bevacizumab
- Modality
- Monoclonal antibody
- Combination Treatment
- Yes
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