Clinical trial • Phase III • Oncology
ziftomenib for Relapsed/refractory acute myeloid leukemia
Phase III trial of ziftomenib for Relapsed/refractory acute myeloid leukemia. None/Not specified-controlled. 141 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Relapsed/refractory acute myeloid leukemia
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 20-05-2024
- First CTIS Authorization Date
- 22-08-2024
Trial design
None/Not specified-controlled Phase III trial across 8 sites in Spain, Italy, Germany.
- Comparator
- None/Not specified
- Target Sample Size
- 141
Eligibility
Recruits 141 Vulnerable population selected; no details on consent or assent handling provided in the record..
- Vulnerable Population
- Vulnerable population selected; no details on consent or assent handling provided in the record.
Recruitment
- Planned Sample Size
- 141
- Recruitment Window Months
- 35
Geography
- Total Number Of Sites
- 8
- Total Number Of Participants
- 30
Spain
- Earliest CTIS Part Ii Submission Date
- 26-07-2024
- Latest Decision Or Authorization Date
- 22-08-2024
- Processing Time Days
- 27
- Number Of Sites
- 4
- Number Of Participants
- 10
Sites
- Site Name
- Hospital Universitario Central De Asturias
- Department Name
- Hematology
- Principal Investigator Name
- Teresa Bernal del Castillo
- Principal Investigator Email
- ensayoshucatb@gmail.com
- Contact Person Name
- Teresa Bernal del Castillo
- Contact Person Email
- ensayoshucatb@gmail.com
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Hematology
- 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 Universitari Vall D Hebron
- Department Name
- Hematology
- Principal Investigator Name
- Olga Salamero Garcia
- Principal Investigator Email
- osalamero@vhio.net
- Contact Person Name
- Olga Salamero Garcia
- Contact Person Email
- osalamero@vhio.net
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Hematology
- Principal Investigator Name
- Eduardo Rodríguez Arbolí
- Principal Investigator Email
- edurodarb@gmail.com
- Contact Person Name
- Eduardo Rodríguez Arbolí
- Contact Person Email
- edurodarb@gmail.com
Italy
- Earliest CTIS Part Ii Submission Date
- 20-08-2024
- Latest Decision Or Authorization Date
- 26-08-2024
- Processing Time Days
- 6
- Number Of Sites
- 3
- Number Of Participants
- 10
Sites
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- Haematology
- Principal Investigator Name
- Simona Sica
- Principal Investigator Email
- simona.sica@unicatt.it
- Contact Person Name
- Simona Sica
- Contact Person Email
- simona.sica@unicatt.it
- Site Name
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
- Department Name
- Haematology
- Principal Investigator Name
- Cristina Papayannidis
- Principal Investigator Email
- cristina.papayannidis@unibo.it
- Contact Person Name
- Cristina Papayannidis
- Contact Person Email
- cristina.papayannidis@unibo.it
- Site Name
- Azienda Unita Sanitaria Locale Della Romagna
- Department Name
- Haematology
- Principal Investigator Name
- Francesco Lanza
- Principal Investigator Email
- francesco.lanza@auslromagna
- Contact Person Name
- Francesco Lanza
- Contact Person Email
- francesco.lanza@auslromagna
Germany
- Earliest CTIS Part Ii Submission Date
- 20-08-2024
- Latest Decision Or Authorization Date
- 27-08-2024
- Processing Time Days
- 7
- Number Of Sites
- 1
- Number Of Participants
- 10
Sites
- Site Name
- Medizinische Hochschule Hannover
- Department Name
- Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation
- Principal Investigator Name
- Florian Heidel
- Principal Investigator Email
- Heidel.Florian@mh-hannover.de
- Contact Person Name
- Florian Heidel
- Contact Person Email
- Heidel.Florian@mh-hannover.de
Sponsor
Primary sponsor
- Full Name
- Kura Oncology Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- Ziftomenib
- Active Substance
- ziftomenib
- Modality
- Small molecule
- Combination Treatment
- Yes
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