Clinical trial • Phase I • Oncology
Clinical trial in Metastatic neuroendocrine prostate cancer
Phase I trial for Metastatic neuroendocrine prostate cancer. open-label. 20 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Metastatic neuroendocrine prostate cancer
- Trial Stage
- Phase I
- Drug Modality
- Radiopharmaceutical
Key dates
- Initial CTIS Submission Date
- 25-01-2024
- First CTIS Authorization Date
- 08-05-2024
Trial design
open-label Phase I trial across 9 sites in France, Germany, Italy and others.
- Open Label
- Yes
- Target Sample Size
- 20
Eligibility
Recruits 20 No vulnerable populations selected; consent/assent process not provided in the record..
- Vulnerable Population
- No vulnerable populations selected; consent/assent process not provided in the record.
Recruitment
- Planned Sample Size
- 20
- Recruitment Window Months
- 31
Geography
- Total Number Of Sites
- 9
- Total Number Of Participants
- 20
France
- Earliest CTIS Part Ii Submission Date
- 08-04-2024
- Latest Decision Or Authorization Date
- 04-12-2025
- Processing Time Days
- 605
- Number Of Sites
- 3
- Number Of Participants
- 5
Sites
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- #1003: Medecine Nucléaire
- Principal Investigator Name
- Clement BAILLY
- Principal Investigator Email
- clement.bailly@chu-nantes.fr
- Contact Person Name
- Clement BAILLY
- Contact Person Email
- clement.bailly@chu-nantes.fr
- Site Name
- CHRU De Nancy
- Department Name
- #1001: Medecine Nucléaire
- Principal Investigator Name
- Pierre OLIVIER
- Principal Investigator Email
- p.olivier@chru-nancy.fr
- Contact Person Name
- Pierre OLIVIER
- Contact Person Email
- p.olivier@chru-nancy.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- #1002: Medecine Nucléaire
- Principal Investigator Name
- Clio BAILLET
- Principal Investigator Email
- CLIO.BAILLET@chu-lille.fr
- Contact Person Name
- Clio BAILLET
- Contact Person Email
- CLIO.BAILLET@chu-lille.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 19-03-2024
- Latest Decision Or Authorization Date
- 03-12-2025
- Processing Time Days
- 624
- Number Of Sites
- 2
- Number Of Participants
- 3
Sites
- Site Name
- Klinikum rechts der Isar der TU Muenchen AöR
- Department Name
- #1101: Klinik und Poliklinik für Nuklearmedizin
- Principal Investigator Name
- Matthias Eiber
- Principal Investigator Email
- matthias.eiber@tum.de
- Contact Person Name
- Matthias Eiber
- Contact Person Email
- matthias.eiber@tum.de
- Site Name
- Rostock University Medical Center
- Department Name
- #1102: Klinik und Poliklinik für Nuklearmedizin
- Principal Investigator Name
- Martin Heuschkel
- Principal Investigator Email
- martin.heuschkel@med.uni-rostock.de
- Contact Person Name
- Martin Heuschkel
- Contact Person Email
- martin.heuschkel@med.uni-rostock.de
Italy
- Earliest CTIS Part Ii Submission Date
- 25-03-2024
- Latest Decision Or Authorization Date
- 04-12-2025
- Processing Time Days
- 619
- Number Of Sites
- 2
- Number Of Participants
- 4
Sites
- Site Name
- Azienda USL IRCCS Di Reggio Emilia
- Department Name
- #1201: Nuclear Medicine
- Principal Investigator Name
- Angelina Filice
- Principal Investigator Email
- angelina.filice@ausl.re.it
- Contact Person Name
- Angelina Filice
- Contact Person Email
- angelina.filice@ausl.re.it
- Site Name
- Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
- Department Name
- #1202: Diagnostic Nuclear Medicine
- Principal Investigator Name
- Federica Matteucci
- Principal Investigator Email
- federica.matteucci@irst.emr.it
- Contact Person Name
- Federica Matteucci
- Contact Person Email
- federica.matteucci@irst.emr.it
Spain
- Earliest CTIS Part Ii Submission Date
- 18-04-2024
- Latest Decision Or Authorization Date
- 05-12-2025
- Processing Time Days
- 596
- Number Of Sites
- 2
- Number Of Participants
- 8
Sites
- Site Name
- Institut Catala D'oncologia
- Department Name
- #1301: Oncologia
- Principal Investigator Name
- Josep Maria Piulats Rodríguez
- Principal Investigator Email
- jmpiulats@iconcologia.net
- Contact Person Name
- Josep Maria Piulats Rodríguez
- Contact Person Email
- jmpiulats@iconcologia.net
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- #1302: Oncologia
- Principal Investigator Name
- Daniel Castellano Gauna
- Principal Investigator Email
- daniel.castellano@salud.madrid.org
- Contact Person Name
- Daniel Castellano Gauna
- Contact Person Email
- daniel.castellano@salud.madrid.org
Sponsor
Primary sponsor
- Full Name
- Novartis Pharma AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
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