Trials / Recruiting
RecruitingNCT06480110
Ebastine in Combination With Docetaxel as a Treatment for Castration-resistant Metastatic Prostate Cancer
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Rigshospitalet, Denmark · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is an open-label phase I/II study evaluating the addition of ebastine to docetaxel in the treatment for metastatic castration resistant prostate cancer. Patients will be randomized in a 2:1 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Docetaxel + Ebastine | Ebastine is administered once daily. |
| DRUG | Docetaxel | docetaxel every three weeks |
Timeline
- Start date
- 2024-06-20
- Primary completion
- 2026-12-01
- Completion
- 2027-12-01
- First posted
- 2024-06-28
- Last updated
- 2025-04-13
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT06480110. Inclusion in this directory is not an endorsement.