Clinical trial • Phase III • Oncology
Decitabine for Acute myeloid leukaemia | Myelodysplastic syndrome | Solid tumor
Phase III trial of Decitabine for Acute myeloid leukaemia | Myelodysplastic syndrome | Solid tumor. 46 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Acute myeloid leukaemia | Myelodysplastic syndrome | Solid tumor
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 12-08-2024
- First CTIS Authorization Date
- 09-09-2024
Trial design
Phase III trial in Spain, Poland, Slovakia and others.
- Target Sample Size
- 46
Eligibility
Recruits 46 No vulnerable population selected; no specific consent/assent information provided..
- Vulnerable Population
- No vulnerable population selected; no specific consent/assent information provided.
Recruitment
- Planned Sample Size
- 46
- Recruitment Window Months
- 48
Geography
- Total Number Of Sites
- 14
- Total Number Of Participants
- 46
Spain
- Earliest CTIS Part Ii Submission Date
- 28-08-2024
- Latest Decision Or Authorization Date
- 09-09-2024
- Processing Time Days
- 12
- Number Of Sites
- 9
- Number Of Participants
- 6
Sites
- Site Name
- Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
- Department Name
- Oncology
- Principal Investigator Name
- Serafín Morales Murillo
- Principal Investigator Email
- Serafinmorales01@gmail.com
- Contact Person Name
- Serafín Morales Murillo
- Contact Person Email
- Serafinmorales01@gmail.com
- Site Name
- University Clinical Hospital Virgen De La Arrixaca
- Department Name
- Oncology
- Principal Investigator Name
- Jeronimo Martinez Garcia
- Principal Investigator Email
- jeronimo@seom.org
- Contact Person Name
- Jeronimo Martinez Garcia
- Contact Person Email
- jeronimo@seom.org
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Hematology Service
- Principal Investigator Name
- Pau Montesinos Fernández
- Principal Investigator Email
- Montesinos_pau@gva.es
- Contact Person Name
- Pau Montesinos Fernández
- Contact Person Email
- Montesinos_pau@gva.es
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Hematology Service
- Principal Investigator Name
- Gala Vega Achabal
- Principal Investigator Email
- gala.vega@startmadrid.com
- Contact Person Name
- Gala Vega Achabal
- Contact Person Email
- gala.vega@startmadrid.com
- Site Name
- University Clinical Hospital Virgen De La Arrixaca
- Department Name
- Hematology Service
- Principal Investigator Name
- Eduardo Jose Salido Fierrez
- Principal Investigator Email
- edujsalido@gmail.com
- Contact Person Name
- Eduardo Jose Salido Fierrez
- Contact Person Email
- edujsalido@gmail.com
- Site Name
- Hospital Universitario Hm Sanchinarro
- Department Name
- Oncology
- Principal Investigator Name
- Juan José Soto
- Principal Investigator Email
- juanj.soto@startmadrid.com
- Contact Person Name
- Juan José Soto
- Contact Person Email
- juanj.soto@startmadrid.com
- Site Name
- Fundacion Rioja Salud
- Department Name
- Oncology
- Principal Investigator Name
- María José de Miguel Luken
- Principal Investigator Email
- maria.demiguel@startmadrid.com
- Contact Person Name
- María José de Miguel Luken
- Contact Person Email
- maria.demiguel@startmadrid.com
- Site Name
- Hospital Hm Nou Delfos
- Department Name
- Oncology
- Principal Investigator Name
- Tatiana Hernandez Guerrero
- Principal Investigator Email
- Tatiana.hernandez@startbarcelona.com
- Contact Person Name
- Tatiana Hernandez Guerrero
- Contact Person Email
- Tatiana.hernandez@startbarcelona.com
- Site Name
- Hospital Universitario Arnau De Vilanova De La Gerencia Territorial De Lleida (duplicate entry if any)
- Department Name
- Oncology
Poland
- Earliest CTIS Part Ii Submission Date
- 28-08-2024
- Latest Decision Or Authorization Date
- 07-10-2024
- Processing Time Days
- 40
- Number Of Sites
- 1
- Number Of Participants
- 10
Sites
- Site Name
- Centrum Badan Klinicznych Piotr Napora Lekarze sp.p.
- Department Name
- Not applicable
- Principal Investigator Name
- Piotr Napora
- Principal Investigator Email
- napora.piotr@cbk.wroc.pl
- Contact Person Name
- Piotr Napora
- Contact Person Email
- napora.piotr@cbk.wroc.pl
Slovakia
- Earliest CTIS Part Ii Submission Date
- 28-08-2024
- Latest Decision Or Authorization Date
- 17-09-2024
- Processing Time Days
- 20
- Number Of Sites
- 1
- Number Of Participants
- 10
Sites
- Site Name
- Summit Clinical Research s.r.o.
- Principal Investigator Name
- Monika Matejková
- Principal Investigator Email
- matejkova.monika@gmail.com
- Contact Person Name
- Monika Matejková
- Contact Person Email
- matejkova.monika@gmail.com
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 28-08-2024
- Latest Decision Or Authorization Date
- 13-09-2024
- Processing Time Days
- 16
- Number Of Sites
- 1
- Number Of Participants
- 10
Sites
- Site Name
- Complex Oncological Center Plovdiv EOOD
- Department Name
- Department of Medical oncology and oncology diseases in gastroenterology
- Principal Investigator Name
- Antoaneta Tomova
- Principal Investigator Email
- dr.tomova@gmail.com
- Contact Person Name
- Antoaneta Tomova
- Contact Person Email
- dr.tomova@gmail.com
Romania
- 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
- 10
Sites
- Site Name
- Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
- Department Name
- Medical Oncology
- Principal Investigator Name
- Laurentia Nicoleta Gales
- Principal Investigator Email
- laurentia.gales@arensia-em.com
- Contact Person Name
- Laurentia Nicoleta Gales
- Contact Person Email
- laurentia.gales@arensia-em.com
- Site Name
- Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
- Department Name
- Medical Oncology
- Principal Investigator Name
- Tudor Eliade Ciuleanu
- Principal Investigator Email
- tudor.ciuleanu.ext@arensia-em.com
- Contact Person Name
- Tudor Eliade Ciuleanu
- Contact Person Email
- tudor.ciuleanu.ext@arensia-em.com
Sponsor
Primary sponsor
- Full Name
- Taiho Oncology Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- Decitabine
- Active Substance
- Decitabine
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Investigational Product Name
- Cedazuridine
- Active Substance
- Cedazuridine
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Combination Treatment
- Yes
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