Clinical trial • Phase III • Oncology
sotorasib (AMG 510) for Advanced solid tumors | KRAS p.G12C mutation | Non-small cell lung cancer
Phase III trial of sotorasib (AMG 510) for Advanced solid tumors | KRAS p.G12C mutation | Non-small cell lung cancer. 970 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced solid tumors | KRAS p.G12C mutation | Non-small cell lung cancer
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 05-08-2024
- First CTIS Authorization Date
- 11-09-2024
Trial design
Phase III trial across 15 sites in Spain, Germany, Belgium and others.
- Biomarker Stratified
- True, biomarker: KRAS p.G12C mutation; strata: not specified
- Target Sample Size
- 970
Eligibility
Recruits 970 No vulnerable populations selected; no information on consent/assent provided..
- Vulnerable Population
- No vulnerable populations selected; no information on consent/assent provided.
Recruitment
- Planned Sample Size
- 970
- Recruitment Window Months
- 71
Geography
- Total Number Of Sites
- 15
- Total Number Of Participants
- 136
Spain
- Earliest CTIS Part Ii Submission Date
- 28-08-2024
- Latest Decision Or Authorization Date
- 16-09-2024
- Processing Time Days
- 19
- Number Of Sites
- 6
- Number Of Participants
- 80
Sites
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncología
- 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 Ramon Y Cajal
- Department Name
- Oncología
- Principal Investigator Name
- Pilar Garrido Lopez
- Principal Investigator Email
- pilargarridol@gmail.com
- Contact Person Name
- Pilar Garrido Lopez
- Contact Person Email
- pilargarridol@gmail.com
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Oncologia Medica
- Principal Investigator Name
- Ivan Manuel Victoria Ruiz
- Principal Investigator Email
- ivictori@recerca.clinic.cat
- Contact Person Name
- Ivan Manuel Victoria Ruiz
- Contact Person Email
- ivictori@recerca.clinic.cat
- Site Name
- Hospital Universitario Puerta De Hierro De Majadahonda
- Department Name
- Oncología Médica
- Principal Investigator Name
- Mariano Provencio Pulla
- Principal Investigator Email
- mprovencio.ensayosclinicos@gmail.com
- Contact Person Name
- Mariano Provencio Pulla
- Contact Person Email
- mprovencio.ensayosclinicos@gmail.com
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Servicio de Oncologia
- Principal Investigator Name
- Luis Paz-Ares Rodriguez
- Principal Investigator Email
- lpazares@hotmail.com
- Contact Person Name
- Luis Paz-Ares Rodriguez
- Contact Person Email
- lpazares@hotmail.com
- Site Name
- Institut Catala D'oncologia
- Department Name
- Oncología Médica
- Principal Investigator Name
- Jose Carlos Ruffinelli Rodriguez
- Principal Investigator Email
- jruffinelli@iconcologia.net
- Contact Person Name
- Jose Carlos Ruffinelli Rodriguez
- Contact Person Email
- jruffinelli@iconcologia.net
Germany
- Earliest CTIS Part Ii Submission Date
- 28-08-2024
- Latest Decision Or Authorization Date
- 12-09-2024
- Processing Time Days
- 15
- Number Of Sites
- 2
- Number Of Participants
- 4
Sites
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- Department of Internal Medicine (Tumour Research)
- Principal Investigator Name
- Marcel Wiesweg
- Principal Investigator Email
- marcel.wiesweg@uk-essen.de
- Contact Person Name
- Marcel Wiesweg
- Contact Person Email
- marcel.wiesweg@uk-essen.de
- Site Name
- University Hospital Cologne AöR
- Department Name
- Centre for Integrated Oncology
- Principal Investigator Name
- Juergen Wolf
- Principal Investigator Email
- juergen.wolf@uk-koeln.de
- Contact Person Name
- Juergen Wolf
- Contact Person Email
- juergen.wolf@uk-koeln.de
Belgium
- Earliest CTIS Part Ii Submission Date
- 28-08-2024
- Latest Decision Or Authorization Date
- 16-09-2024
- Processing Time Days
- 19
- Number Of Sites
- 2
- Number Of Participants
- 23
Sites
- Site Name
- Antwerp University Hospital
- Department Name
- 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
- Oncology
- Principal Investigator Name
- Jean-Pascal Machiels
- Principal Investigator Email
- jean-pascal.machiels@saintluc.uclouvain.be
- Contact Person Name
- Jean-Pascal Machiels
- Contact Person Email
- jean-pascal.machiels@saintluc.uclouvain.be
Austria
- Earliest CTIS Part Ii Submission Date
- 28-08-2024
- Latest Decision Or Authorization Date
- 20-09-2024
- Processing Time Days
- 23
- Number Of Sites
- 1
- Number Of Participants
- 5
Sites
- Site Name
- SCRI CCCIT Ges.m.b.H.
- Department Name
- Department of Internal Medicine IIII
- Principal Investigator Name
- Lukas Weiss
- Principal Investigator Email
- lu.weiss@salk.at
- Contact Person Name
- Lukas Weiss
- Contact Person Email
- lu.weiss@salk.at
Netherlands
- Earliest CTIS Part Ii Submission Date
- 28-08-2024
- Latest Decision Or Authorization Date
- 11-09-2024
- Processing Time Days
- 14
- Number Of Sites
- 1
- Number Of Participants
- 5
Sites
- Site Name
- Universitair Medisch Centrum Utrecht
- Department Name
- Medical oncology
- Principal Investigator Name
- Jeanine Roodhart
- Principal Investigator Email
- j.roodhart@umcutrecht.nl
- Contact Person Name
- Jeanine Roodhart
- Contact Person Email
- j.roodhart@umcutrecht.nl
Italy
- Earliest CTIS Part Ii Submission Date
- 28-08-2024
- Latest Decision Or Authorization Date
- 02-10-2024
- Processing Time Days
- 35
- Number Of Sites
- 3
- Number Of Participants
- 19
Sites
- Site Name
- Azienda Ospedaliero Universitaria Pisana
- Department Name
- Ospedale Santa Chiara Centro di Farmacologia Clinica per la Sperimentazione dei Farmaci
- Principal Investigator Name
- Chiara Cremolini
- Principal Investigator Email
- chiaracremolini@gmail.com
- Contact Person Name
- Chiara Cremolini
- Contact Person Email
- chiaracremolini@gmail.com
- Site Name
- ASST Grande Ospedale Metropolitano Niguarda
- Department Name
- Dipartimento Ematologia Oncologia e Medicina molecolare
- Principal Investigator Name
- Salvatore Siena
- Principal Investigator Email
- salvatore.siena@ospedaleniguarda.it
- Contact Person Name
- Salvatore Siena
- Contact Person Email
- salvatore.siena@ospedaleniguarda.it
- Site Name
- Centro Ricerche Cliniche Di Verona S.r.l.
- Department Name
- Clinical Pharmacology Unit
- Principal Investigator Name
- Michele Milella
- Principal Investigator Email
- michele.milella@aovr.veneto.it
- Contact Person Name
- Michele Milella
- Contact Person Email
- michele.milella@aovr.veneto.it
Sponsor
Primary sponsor
- Full Name
- Amgen Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- Sotorasib (AMG 510)
- Active Substance
- sotorasib (AMG 510)
- Modality
- Small molecule
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