Clinical trial • Phase I/II • Oncology
INCB000928 for Anemia due to myelofibrosis
Phase I/II trial of INCB000928 for Anemia due to myelofibrosis. open-label. 90 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Anemia due to myelofibrosis
- Trial Stage
- Phase I/II
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 28-06-2024
- First CTIS Authorization Date
- 05-09-2024
Trial design
open-label Phase I/II trial across 8 sites in France, Italy.
- Open Label
- Yes
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 90
Eligibility
Recruits 90 isVulnerablePopulationSelected:false. No vulnerable population considerations or consent/assent handling information provided in the record..
- Vulnerable Population
- isVulnerablePopulationSelected:false. No vulnerable population considerations or consent/assent handling information provided in the record.
Recruitment
- Planned Sample Size
- 90
- Recruitment Window Months
- 59
Geography
- Total Number Of Sites
- 8
- Total Number Of Participants
- 90
France
- Earliest CTIS Part Ii Submission Date
- 16-07-2024
- Latest Decision Or Authorization Date
- 05-09-2024
- Processing Time Days
- 51
- Number Of Sites
- 3
- Number Of Participants
- 40
Sites
- Site Name
- Centre Hospitalier Universitaire D'Angers
- Department Name
- Blood diseases
- Principal Investigator Name
- Françoise Boyer
- Principal Investigator Email
- frboyer-perrard@chu-angers.fr
- Contact Person Name
- Françoise Boyer
- Contact Person Email
- frboyer-perrard@chu-angers.fr
- Site Name
- Institut Paoli Calmettes
- Department Name
- Hematology
- Principal Investigator Name
- Jerome Rey
- Principal Investigator Email
- reyj@ipc.unicancer.fr
- Contact Person Name
- Jerome Rey
- Contact Person Email
- reyj@ipc.unicancer.fr
- Site Name
- Hopital Saint Louis
- Department Name
- Centre d'Investigations Cliniques
- Principal Investigator Name
- Jean-Jacques Kiladjian
- Principal Investigator Email
- jean-jacques.kiladjian@aphp.fr
- Contact Person Name
- Jean-Jacques Kiladjian
- Contact Person Email
- jean-jacques.kiladjian@aphp.fr
Italy
- Earliest CTIS Part Ii Submission Date
- 16-07-2024
- Latest Decision Or Authorization Date
- 19-03-2026
- Processing Time Days
- 611
- Number Of Sites
- 5
- Number Of Participants
- 50
Sites
- Site Name
- Careggi University Hospital
- Department Name
- Departmental Hospital Section (SOD) of Hematology
- Principal Investigator Name
- Paola Guglielmelli
- Principal Investigator Email
- paola.guglielmelli@unifi.it
- Contact Person Name
- Paola Guglielmelli
- Contact Person Email
- paola.guglielmelli@unifi.it
- Site Name
- Hospital Santa Maria Della Misericordia
- Department Name
- Departmental of Hematology
- Principal Investigator Name
- Paolo Sportoletti
- Principal Investigator Email
- paolo.sportoletti@unipg.it
- Contact Person Name
- Paolo Sportoletti
- Contact Person Email
- paolo.sportoletti@unipg.it
- Site Name
- Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
- Department Name
- Departmental of Oncology and Hematology
- Principal Investigator Name
- Alessandro Rambaldi
- Principal Investigator Email
- arambaldi@asst-pg23.it
- Contact Person Name
- Alessandro Rambaldi
- Contact Person Email
- arambaldi@asst-pg23.it
- Site Name
- Azienda Ospedaliero-Universitaria San Luigi Gonzaga
- Department Name
- Dpt of Clinical and Biological Sciences
- Principal Investigator Name
- Marco De Gobbi
- Principal Investigator Email
- marco.degobbi@unito.it
- Contact Person Name
- Marco De Gobbi
- Contact Person Email
- marco.degobbi@unito.it
- Site Name
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
- Department Name
- Complex Operational Unit (UOC) Hematology - Via G. Massarenti 9 40138 Bologna Italy
- Principal Investigator Name
- Francesca Palandri
- Principal Investigator Email
- francesca.palandri@unibo.it
- Contact Person Name
- Francesca Palandri
- Contact Person Email
- francesca.palandri@unibo.it
Sponsor
Primary sponsor
- Full Name
- Incyte Corp.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- INCB000928
- Modality
- Small molecule
- Investigational Product Name
- Ruxolitinib
- Modality
- Small molecule
- Combination Treatment
- Yes
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