Clinical trial • Phase III • Oncology
cabozantinib for Bladder cancer | Kidney cancer
Phase III trial of cabozantinib for Bladder cancer | Kidney cancer. adaptive. 1172 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Bladder cancer | Kidney cancer
- Trial Stage
- Phase III
- Drug Modality
- Small molecule|Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 21-08-2024
- First CTIS Authorization Date
- 16-09-2024
Trial design
adaptive Phase III trial across 7 sites in Spain, France.
- Adaptive
- True - Dose escalation design (dose escalation cohorts / escalation elements described in title)
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 1172
Recruitment
- Planned Sample Size
- 1172
- Recruitment Window Months
- 93
Geography
- Total Number Of Sites
- 7
- Total Number Of Participants
- 320
Spain
- Earliest CTIS Part Ii Submission Date
- 12-08-2024
- Latest Decision Or Authorization Date
- 16-09-2024
- Processing Time Days
- 35
- Number Of Sites
- 6
- Number Of Participants
- 160
Sites
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncology
- Principal Investigator Name
- Cristina Suárez Rodríguez
- Principal Investigator Email
- csuarez@vhio.net
- Contact Person Name
- Cristina Suárez Rodríguez
- Contact Person Email
- csuarez@vhio.net
- Site Name
- Institut Catala D'oncologia
- Department Name
- Oncology
- Principal Investigator Name
- Albert Font Pous
- Principal Investigator Email
- afont@iconcologia.net
- Contact Person Name
- Albert Font Pous
- Contact Person Email
- afont@iconcologia.net
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Oncology
- Principal Investigator Name
- Begoña Mellado González
- Principal Investigator Email
- bmellado@clinic.cat
- Contact Person Name
- Begoña Mellado González
- Contact Person Email
- bmellado@clinic.cat
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Oncology
- Principal Investigator Name
- Pablo Gajate Boreau
- Principal Investigator Email
- pgajateborau@gmail.com
- Contact Person Name
- Pablo Gajate Boreau
- Contact Person Email
- pgajateborau@gmail.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncology
- Principal Investigator Name
- Enriqueta Felip Font
- Principal Investigator Email
- enriqueta.felip@vallhebron.cat
- Contact Person Name
- Enriqueta Felip Font
- Contact Person Email
- enriqueta.felip@vallhebron.cat
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Oncology
- Principal Investigator Name
- Santiago Ponce Aix
- Principal Investigator Email
- sponceaix@gmail.com
- Contact Person Name
- Santiago Ponce Aix
- Contact Person Email
- sponceaix@gmail.com
France
- Earliest CTIS Part Ii Submission Date
- 12-08-2024
- Latest Decision Or Authorization Date
- 19-09-2024
- Processing Time Days
- 38
- Number Of Sites
- 1
- Number Of Participants
- 160
Sites
- Site Name
- Institut Gustave Roussy
- Department Name
- Départment D'Oncologie Médicale
- Principal Investigator Name
- Yohann Loriot
- Principal Investigator Email
- yohann.loriot@gustaveroussy.fr
- Contact Person Name
- Yohann Loriot
- Contact Person Email
- yohann.loriot@gustaveroussy.fr
Sponsor
Primary sponsor
- Full Name
- Exelixis Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- Cabozantinib (XL184)
- Active Substance
- cabozantinib
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Investigational Product Name
- Atezolizumab
- Active Substance
- atezolizumab
- Modality
- Monoclonal antibody
- Routes Of Administration
- Intravenous
- Route
- Intravenous
- Combination Treatment
- Yes
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