drugset / Trial / NCT04428203
Epidiolex (CBD) in Patients With Biochemically Recurrent Prostate Cancer
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cannabidiol | Other / unclassified | 600 mg | Oral |
| Subject | Cannabidiol | Other / unclassified | 800 mg | Oral |