Ignite Creation Date:
2024-05-06 @ 2:46 PM
Last Modification Date:
2024-10-26 @ 1:37 PM
Study NCT ID:
NCT04428203
Status:
COMPLETED
Last Update Posted:
2021-10-15
First Post:
2020-06-06
Brief Title:
Epidiolex CBD in Patients With Biochemically Recurrent Prostate Cancer
Sponsor:
Zin W Myint
Organization:
University of Kentucky
Study Overview
Official Title:
A Phase IIb Study on the Safety of Epidiolex in Patients With Prostate Cancer With Rising PSA After Localized Therapy With Either Surgery or Radiation
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this phase IIb 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
Detailed Description:
Cannabinoids CBD have been widely used in medicines for centuries to control pain nausea or vomiting and to stimulate appetite especially in cancer patients Both cannabinoids receptor 1CB1 and cannabinoids receptor 2 CB2 were highly expressed in cultured prostate cancer cells compared to normal prostate cell lines CBD inhibits tumor growth in xenograft model
Clinicians have been challenged to improve the treatment of biochemically recurrent BCR prostate cancer in which prostatic specific antigen PSA rises without radiological or clinical progression years after localized treatment radical prostatectomy or radiation therapy with or without hormonal treatment Approximately 50-90 of men with high-risk prostate cancer will experience a BCR Based on the abovementioned preclinical observations of CBDs effect on prostate cancer and its safety data in two non-cancer populations a phase I study of CBD in men with biochemically recurrent prostate cancer will be conducted
Clinicians have been challenged to improve the treatment of biochemically recurrent BCR prostate cancer in which prostatic specific antigen PSA rises without radiological or clinical progression years after localized treatment radical prostatectomy or radiation therapy with or without hormonal treatment Approximately 50-90 of men with high-risk prostate cancer will experience a BCR Based on the abovementioned preclinical observations of CBDs effect on prostate cancer and its safety data in two non-cancer populations a phase I study of CBD in men with biochemically recurrent prostate cancer will be conducted
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None