Clinical trial • Phase III • Oncology
[177Lu]Lu-DOTA-TATE for Glioblastoma
Phase III trial of [177Lu]Lu-DOTA-TATE for Glioblastoma. 21 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Glioblastoma
- Trial Stage
- Phase III
- Drug Modality
- Radiopharmaceutical
Key dates
- Initial CTIS Submission Date
- 24-04-2024
- First CTIS Authorization Date
- 23-05-2024
Trial design
Phase III trial across 8 sites in France, Spain, Portugal.
- Target Sample Size
- 21
Recruitment
- Planned Sample Size
- 21
- Recruitment Window Months
- 50
Geography
- Total Number Of Sites
- 8
- Total Number Of Participants
- 34
France
- Earliest CTIS Part Ii Submission Date
- 19-01-2024
- Latest Decision Or Authorization Date
- 18-12-2025
- Processing Time Days
- 699
- Number Of Sites
- 2
- Number Of Participants
- 9
Sites
- Site Name
- Hospital Pierre Wertheimer
- Department Name
- #1000:Service de neuro-oncologie
- Principal Investigator Name
- François DUCRAY
- Principal Investigator Email
- francois.ducray@chu-lyon.fr
- Contact Person Name
- François DUCRAY
- Contact Person Email
- francois.ducray@chu-lyon.fr
- Site Name
- Assistance Publique Hopitaux De Marseille
- Department Name
- #1001:Service Medecine Nucleaire
- Principal Investigator Name
- Eric GUEDJ
- Principal Investigator Email
- eric.guedj@ap-hm.fr
- Contact Person Name
- Eric GUEDJ
- Contact Person Email
- eric.guedj@ap-hm.fr
Spain
- Earliest CTIS Part Ii Submission Date
- 19-01-2024
- Latest Decision Or Authorization Date
- 18-12-2025
- Processing Time Days
- 699
- Number Of Sites
- 5
- Number Of Participants
- 21
Sites
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- #3002:Oncology
- Principal Investigator Name
- Juan Manuel Sepulveda Sanchez
- Principal Investigator Email
- sepulvedasanchez@seom.org
- Contact Person Name
- Juan Manuel Sepulveda Sanchez
- Contact Person Email
- sepulvedasanchez@seom.org
- Site Name
- Hospital Universitario Virgen De Las Nieves
- Department Name
- #3003:Oncology
- Principal Investigator Name
- Raquel Luque Caro
- Principal Investigator Email
- rluquc@fundacionhvn.org
- Contact Person Name
- Raquel Luque Caro
- Contact Person Email
- rluquc@fundacionhvn.org
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- #3001:Oncology
- Principal Investigator Name
- Estela Pineda Losada
- Principal Investigator Email
- epineda@clinic.cat
- Contact Person Name
- Estela Pineda Losada
- Contact Person Email
- epineda@clinic.cat
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- #3000:Oncology
- Principal Investigator Name
- Maria Vieito Villar
- Principal Investigator Email
- mvieito@vhio.net
- Contact Person Name
- Maria Vieito Villar
- Contact Person Email
- mvieito@vhio.net
- Site Name
- Hospital Universitario Hm Sanchinarro
- Department Name
- #3004:Oncology
- 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
Portugal
- Earliest CTIS Part Ii Submission Date
- 19-01-2024
- Latest Decision Or Authorization Date
- 16-12-2025
- Processing Time Days
- 697
- Number Of Sites
- 1
- Number Of Participants
- 4
Sites
- Site Name
- Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
- Department Name
- #2000:Serviço Oncologia Médica
- Principal Investigator Name
- Filipa Carneiro
- Principal Investigator Email
- ana.carneiro@ipoporto.min-saude.pt
- Contact Person Name
- Filipa Carneiro
- Contact Person Email
- ana.carneiro@ipoporto.min-saude.pt
Sponsor
Primary sponsor
- Full Name
- Novartis Pharma AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Investigational products
- Investigational Product Name
- [177Lu]Lu-DOTA-TATE
- Active Substance
- [177Lu]Lu-DOTA-TATE
- Modality
- Radiopharmaceutical
- Combination Treatment
- Yes
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