CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 21 enrolled
Drug / intervention
Epidiolex Oral Liquid Product +2 moredrug
Likely dose
Epidiolex Oral Liquid Product 600 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04428203
NCT04428203Phase 1Completed
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A Phase I/Ib Study on the Safety of Epidiolex in Patients With Prostate Cancer With Rising PSA After Localized Therapy With Either Surgery or Radiation

Zin W Myint·interventional·Posted Jun 11, 2020·Updated Mar 5, 2025

In Brief

A Phase 1 clinical trial evaluating Epidiolex Oral Liquid Product for Prostate Cancer Recurrent and 2 related conditions. Completed, enrolled 21 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer Recurrent, Prostate Cancer, Prostate Adenocarcinoma
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
202120222023202420252026
First PostedJun 11, 2020
Enrollment StartAug 3, 2020
Primary CompletionAug 20, 2021
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 6.1 years ago

Interventions

Epidiolex Oral Liquid Productdrug

600 mg Oral solution

Epidiolex Oral Liquid Productdrug

800 mg oral solution

Epidiolex Oral Liquid Productdrug

800 mg oral solution