drugset / Trial / NCT04428203

Epidiolex (CBD) in Patients With Biochemically Recurrent Prostate Cancer

NCT04428203

Phase 1 Completed 21 enrolled Zin W Myint
Non-randomizedSequentialOpen-labelTreatment

Summary

The purpose of this phase I/Ib study is to determine the safety profile of Epidiolex (CBD oil) in biochemically recurrent prostate cancer patients. The study consists of a dose escalation part and dose expansion part. The dose expansion part of the study will use the maximum tolerated dose (MTD) determined in the dose escalation part to assess the activity, safety and tolerability of the investigational product in patients with biochemically recurrent prostate cancer after localized therapy with either surgery or radiation.

Timeline

Start
2020-08-03
Primary completion
2021-08-20
Completion
2021-08-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Cannabidiol Other / unclassified 600 mg Oral
Subject Cannabidiol Other / unclassified 800 mg Oral