drugset / Trial / NCT06480110

Ebastine in Combination With Docetaxel as a Treatment for Castration-resistant Metastatic Prostate Cancer

NCT06480110

Phase 1/2 Recruiting 30 enrolled Rigshospitalet, Denmark Danish Cancer Society · collab
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2024-06-20
Primary completion
2026-12-01
Completion
2027-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Ebastine Small molecule
Background Docetaxel Small molecule