Clinical trial • Phase I • Oncology
XL092 for Clear cell renal cell carcinoma | Non-clear cell renal cell carcinoma | Hormone receptor-positive breast cancer | Metastatic castration-resistant prostate cancer | Colorectal cancer
Phase I trial of XL092 for Clear cell renal cell carcinoma | Non-clear cell renal cell carcinoma | Hormone receptor-positive breast cancer | Metastatic ca…
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Clear cell renal cell carcinoma | Non-clear cell renal cell carcinoma | Hormone receptor-positive breast cancer | Metastatic castration-resistant prostate cancer | Colorectal cancer
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 09-08-2024
- First CTIS Authorization Date
- 11-09-2024
Trial design
None/Not specified-controlled, adaptive Phase I trial across 24 sites in Belgium, Czechia, Germany and others.
- Comparator
- None/Not specified
- Adaptive
- True - Dose-escalation and expansion design; specific escalation rules not provided in the public record.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 180
Recruitment
- Planned Sample Size
- 180
- Recruitment Window Months
- 94
Geography
- Total Number Of Sites
- 24
- Total Number Of Participants
- 140
Belgium
- Earliest CTIS Part Ii Submission Date
- 30-08-2024
- Latest Decision Or Authorization Date
- 12-09-2024
- Processing Time Days
- 13
- Number Of Sites
- 3
- Number Of Participants
- 6
Sites
- Site Name
- Antwerp University Hospital
- Department Name
- Medical Oncology
- Principal Investigator Name
- Hans Prenen
- Principal Investigator Email
- hans.prenen@uza.be
- Contact Person Name
- Hans Prenen
- Contact Person Email
- hans.prenen@uza.be
- Site Name
- Cliniques Universitaires Saint-Luc
- Department Name
- Medical Oncology
- Principal Investigator Name
- Jean-Pascal Machiels
- Principal Investigator Email
- jean-pascal.machiels@uclouvain.be
- Contact Person Name
- Jean-Pascal Machiels
- Contact Person Email
- jean-pascal.machiels@uclouvain.be
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Medical Oncology
- Principal Investigator Name
- Sylvie Rottey
- Principal Investigator Email
- sylvie.rottey@uzgent.be
- Contact Person Name
- Sylvie Rottey
- Contact Person Email
- sylvie.rottey@uzgent.be
Czechia
- Earliest CTIS Part Ii Submission Date
- 30-08-2024
- Latest Decision Or Authorization Date
- 10-03-2026
- Processing Time Days
- 557
- Number Of Sites
- 1
- Number Of Participants
- 4
Sites
- Site Name
- Fakultni Thomayerova nemocnice
- Department Name
- Oncology
- Principal Investigator Name
- Tomas Buchler
- Principal Investigator Email
- tomas.buchler@ftn.cz
- Contact Person Name
- Tomas Buchler
- Contact Person Email
- tomas.buchler@ftn.cz
Germany
- Earliest CTIS Part Ii Submission Date
- 30-08-2024
- Latest Decision Or Authorization Date
- 11-03-2026
- Processing Time Days
- 558
- Number Of Sites
- 2
- Number Of Participants
- 10
Sites
- Site Name
- Klinikum rechts der Isar der TU Muenchen AöR
- Department Name
- Urological Oncology
- Principal Investigator Name
- Margitta Retz
- Principal Investigator Email
- margitta.retz@tum.de
- Contact Person Name
- Margitta Retz
- Contact Person Email
- margitta.retz@tum.de
- Site Name
- Haematologisch Onkologische Praxis Eppendorf
- Department Name
- Oncology
- Principal Investigator Name
- Alexander Stein
- Principal Investigator Email
- stein@hope-hamburg.de
- Contact Person Name
- Alexander Stein
- Contact Person Email
- stein@hope-hamburg.de
France
- Earliest CTIS Part Ii Submission Date
- 30-08-2024
- Latest Decision Or Authorization Date
- 11-03-2026
- Processing Time Days
- 558
- Number Of Sites
- 9
- Number Of Participants
- 57
Sites
- Site Name
- Hospices Civils De Lyon
- Department Name
- Medical Oncology
- Principal Investigator Name
- Benoit You
- Principal Investigator Email
- benoit.you@chu-lyon.fr
- Contact Person Name
- Benoit You
- Contact Person Email
- benoit.you@chu-lyon.fr
- Site Name
- Institut Paoli Calmettes
- Department Name
- Medical Oncology
- Principal Investigator Name
- Gwenaelle Gravis-Mescam
- Principal Investigator Email
- gravisg@ipc.unicancer.fr
- Contact Person Name
- Gwenaelle Gravis-Mescam
- Contact Person Email
- gravisg@ipc.unicancer.fr
- Site Name
- Institut Bergonie
- Department Name
- Medical Oncology
- Principal Investigator Name
- Guilhem Roubaud
- Principal Investigator Email
- g.roubaud@bordeaux.unicancer.fr
- Contact Person Name
- Guilhem Roubaud
- Contact Person Email
- g.roubaud@bordeaux.unicancer.fr
- Site Name
- Centre Jean Perrin
- Department Name
- Medical Oncology
- Principal Investigator Name
- Hakim Mahammedi
- Principal Investigator Email
- hakim.mahammedi@cjp.fr
- Contact Person Name
- Hakim Mahammedi
- Contact Person Email
- hakim.mahammedi@cjp.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Medical Oncology
- Principal Investigator Name
- Jacques Medioni
- Principal Investigator Email
- jacques.medioni@aphp.fr
- Contact Person Name
- Jacques Medioni
- Contact Person Email
- jacques.medioni@aphp.fr
- Site Name
- Centre Francois Baclesse
- Department Name
- Medical Oncology
- Principal Investigator Name
- Florence Joly
- Principal Investigator Email
- f.joly@baclesse.unicancer.fr
- Contact Person Name
- Florence Joly
- Contact Person Email
- f.joly@baclesse.unicancer.fr
- 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 De Cancerologie De L Ouest
- Department Name
- Medical Oncology
- Principal Investigator Name
- Marie Robert
- Principal Investigator Email
- marie.robert@ico.unicancer.fr
- Contact Person Name
- Marie Robert
- Contact Person Email
- marie.robert@ico.unicancer.fr
- Site Name
- Oncopole Claudius Regaud
- Department Name
- Medical Oncology
- Principal Investigator Name
- Damien Pouessel
- Principal Investigator Email
- pouessel.damien@iuct-oncopole.fr
- Contact Person Name
- Damien Pouessel
- Contact Person Email
- pouessel.damien@iuct-oncopole.fr
Spain
- Earliest CTIS Part Ii Submission Date
- 30-08-2024
- Latest Decision Or Authorization Date
- 17-03-2026
- Processing Time Days
- 564
- Number Of Sites
- 9
- Number Of Participants
- 63
Sites
- Site Name
- Hospital Del Mar
- Department Name
- Medical Oncology
- Principal Investigator Name
- Alejo Martín Rodríguez-Vida Rodríguez
- Principal Investigator Email
- arodriguezvida@psmar.cat
- Contact Person Name
- Alejo Martín Rodríguez-Vida Rodríguez
- Contact Person Email
- arodriguezvida@psmar.cat
- Site Name
- Hospital Clinico San Carlos
- Department Name
- Medical Oncology
- Principal Investigator Name
- Jorge Bartolomé Arcilla
- Principal Investigator Email
- jorge.bartolome@salud.madrid.org
- Contact Person Name
- Jorge Bartolomé Arcilla
- Contact Person Email
- jorge.bartolome@salud.madrid.org
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Medical 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 Quironsalud Barcelona
- Department Name
- Medical Oncology
- Principal Investigator Name
- Fabricio Racca Bussano
- Principal Investigator Email
- fabricio.racca@iob-onco.com
- Contact Person Name
- Fabricio Racca Bussano
- Contact Person Email
- fabricio.racca@iob-onco.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Medical 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
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Medical Oncology
- Principal Investigator Name
- Alejandro Falcon Gonzalez
- Principal Investigator Email
- alejandro.falcon.sspa@juntadeandalucia.es
- Contact Person Name
- Alejandro Falcon Gonzalez
- Contact Person Email
- alejandro.falcon.sspa@juntadeandalucia.es
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Medical Oncology
- Principal Investigator Name
- Guillermo De Velasco Oria de Rueda
- Principal Investigator Email
- guillermoantonio.velasco@salud.madrid.org
- Contact Person Name
- Guillermo De Velasco Oria de Rueda
- Contact Person Email
- guillermoantonio.velasco@salud.madrid.org
- Site Name
- Parc Tauli Hospital Universitari
- Department Name
- Medical Oncology
- Principal Investigator Name
- Enrique Gallardo Díaz
- Principal Investigator Email
- egallardo@tauli.cat
- Contact Person Name
- Enrique Gallardo Díaz
- Contact Person Email
- egallardo@tauli.cat
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Medical Oncology
- Principal Investigator Name
- Aitana Calvo Ferrandiz
- Principal Investigator Email
- pilaraitana.calvo@salud.madrid.org
- Contact Person Name
- Aitana Calvo Ferrandiz
- Contact Person Email
- pilaraitana.calvo@salud.madrid.org
Sponsor
Primary sponsor
- Full Name
- Exelixis Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- XL092
- Combination Treatment
- Yes
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