Ignite Creation Date:
2024-07-17 @ 10:55 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06480110
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2020-11-18
Brief Title:
Ebastine in Combination With Docetaxel as a Treatment for Castration-resistant Metastatic Prostate Cancer
Sponsor:
Rigshospitalet Denmark
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
Ebastine in Combination With Docetaxel as a Treatment for Castration-resistant Metastatic Prostate Cancer
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open-label phase III study evaluating the addition of ebastine to docetaxel in the treatment for metastatic castration resistant prostate cancer
Patients will be randomized in a 21 fashion to receive ebastine daily during and after treatment with a maximum of 10 courses of docetaxel
The primary endpoint is change in the profile of urinary and blood lipids to indicate absorption and possible efficacy of ebastine
Secondary endpoints include PSA response and radiologic progression free survival
Patients will be randomized in a 21 fashion to receive ebastine daily during and after treatment with a maximum of 10 courses of docetaxel
The primary endpoint is change in the profile of urinary and blood lipids to indicate absorption and possible efficacy of ebastine
Secondary endpoints include PSA response and radiologic progression free survival
Detailed Description:
The complete study protocol can be studied by contacting the authors
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None