Clinical trial • Phase III • Oncology
Enzalutamide for Prostate cancer | Hot flush
Phase III trial of Enzalutamide for Prostate cancer | Hot flush. 56 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Prostate cancer | Hot flush
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 24-11-2025
- First CTIS Authorization Date
- 03-04-2026
Trial design
Phase III trial across 3 sites in Bulgaria.
- Target Sample Size
- 56
Recruitment
- Planned Sample Size
- 56
- Recruitment Window Months
- 8
Geography
- Total Number Of Sites
- 3
- Total Number Of Participants
- 56
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 24-03-2026
- Latest Decision Or Authorization Date
- 03-04-2026
- Processing Time Days
- 10
- Number Of Sites
- 3
- Number Of Participants
- 56
Sites
- Site Name
- Complex Oncology Center Burgas EOOD
- Department Name
- First Department of Medical Oncology
- Principal Investigator Name
- Ivan Kazmukov
- Principal Investigator Email
- ikazmukov@gmail.com
- Contact Person Name
- Ivan Kazmukov
- Contact Person Email
- ikazmukov@gmail.com
- Site Name
- Medical Center Comac Medical Ltd.
- Principal Investigator Name
- Dobrin Svinarov
- Principal Investigator Email
- dobrin.svinarov@comac-medical.com
- Contact Person Name
- Dobrin Svinarov
- Contact Person Email
- dobrin.svinarov@comac-medical.com
- Site Name
- Medical Center Comac Medical Ltd.
- Principal Investigator Name
- Dobrin Svinarov
- Principal Investigator Email
- dobrin.svinarov@comac-medical.com
- Contact Person Name
- Dobrin Svinarov
- Contact Person Email
- dobrin.svinarov@comac-medical.com
Sponsor
Primary sponsor
- Full Name
- Astellas Pharma Global Development Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- Enzalutamide
- Active Substance
- Enzalutamide
- Modality
- Small molecule
- Investigational Product Name
- Apalutamide
- Active Substance
- Apalutamide
- Modality
- Small molecule
- Investigational Product Name
- Bicalutamide
- Active Substance
- Bicalutamide
- Modality
- Small molecule
- Investigational Product Name
- Fezolinetant
- Active Substance
- Fezolinetant
- Modality
- Small molecule
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