Clinical trial • Phase I • Oncology
Temozolomide for Glioblastoma
Phase I trial of Temozolomide for Glioblastoma. open-label, none/not specified-controlled, adaptive. 27 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Glioblastoma
- Trial Stage
- Phase I
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 09-08-2024
- First CTIS Authorization Date
- 11-09-2024
Trial design
open-label, none/not specified-controlled, adaptive Phase I trial across 4 sites in Germany, Netherlands.
- Open Label
- Yes
- Comparator
- None/Not specified
- Adaptive
- Yes
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 27
Recruitment
- Planned Sample Size
- 27
- Recruitment Window Months
- 16
Geography
- Total Number Of Sites
- 4
- Total Number Of Participants
- 27
Germany
- Earliest CTIS Part Ii Submission Date
- 15-08-2024
- Latest Decision Or Authorization Date
- 11-09-2024
- Processing Time Days
- 27
- Number Of Sites
- 3
- Number Of Participants
- 21
Sites
- Site Name
- Universitaetsklinikum Aachen AöR
- Department Name
- Clinic for Neurosurgery
- Principal Investigator Name
- Daniel Delev
- Principal Investigator Email
- ddelev@ukaachen.de
- Contact Person Name
- Daniel Delev
- Contact Person Email
- ddelev@ukaachen.de
- Site Name
- University Hospital Cologne AöR
- Department Name
- Center for Neurosurgery
- Principal Investigator Name
- Roland Goldbrunner LKP
- Principal Investigator Email
- roland.goldbrunner@uk-koeln.de
- Contact Person Name
- Roland Goldbrunner LKP
- Contact Person Email
- roland.goldbrunner@uk-koeln.de
- Site Name
- University Medical Center Hamburg-Eppendorf
- Department Name
- Neurosurgery
- Principal Investigator Name
- Malte Mohme
- Principal Investigator Email
- M.Mohme@uke.de
- Contact Person Name
- Malte Mohme
- Contact Person Email
- M.Mohme@uke.de
Netherlands
- Earliest CTIS Part Ii Submission Date
- 15-08-2024
- Latest Decision Or Authorization Date
- 11-09-2024
- Processing Time Days
- 27
- Number Of Sites
- 1
- Number Of Participants
- 6
Sites
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Department of Neurosurgery
- Principal Investigator Name
- Dr. C.M.F. Dirven
- Principal Investigator Email
- c.dirven@erasmusmc.nl
- Contact Person Name
- Dr. C.M.F. Dirven
- Contact Person Email
- c.dirven@erasmusmc.nl
Sponsor
Primary sponsor
- Full Name
- Double Bond Pharmaceutical AB
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Sweden
Investigational products
- Investigational Product Name
- SI-053 (temozolomide-based)
- Active Substance
- Temozolomide
- Modality
- Small molecule
- Routes Of Administration
- Intracranial
- Route
- Intracranial
- Combination Treatment
- Yes
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