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Epidiolex (CBD) in Patients With Biochemically Recurrent Prostate Cancer

NCT04428203 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2025-03-05

Study results available
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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.

Conditions

Interventions

DRUG

Epidiolex Oral Liquid Product

600 mg Oral solution

DRUG

Epidiolex Oral Liquid Product

800 mg oral solution

DRUG

Epidiolex Oral Liquid Product

800 mg oral solution

Sponsors & Collaborators

  • Zin W Myint

    lead OTHER

Principal Investigators

  • Zin W. Myint, MD · University of Kentucky

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-03
Primary Completion
2021-08-20
Completion
2021-08-20
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04428203 on ClinicalTrials.gov