Epidiolex (CBD) in Patients With Biochemically Recurrent Prostate Cancer (NCT04428203) | Clinical Trial Compass
CompletedPhase 1
Epidiolex (CBD) in Patients With Biochemically Recurrent Prostate Cancer
United States21 participantsStarted 2020-08-03
Plain-language 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.
Who can participate
Age range18 Years
SexMALE
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Inclusion Criteria:
* Completion of localized therapy (prostatectomy or radiotherapy) for prostate adenocarcinoma (either histologically or cytologically confirmed)
* Biochemical (PSA) recurrence, defined as: \* PSA of \>= 0.2 ng/ml that has increased above nadir following radical prostatectomy OR \* PSA increase of 2.0 ng/ml above post-therapy nadir after radiotherapy NOTE: PSA measured at two consecutive time points (separated by 4 or more weeks) is required in order to demonstrate the requisite increase in PSA
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
* Absolute neutrophil count \>= 1,500/microliters (at baseline \[pre-study\])
* Platelets \>= 80,000/microliters (at baseline \[pre-study\])
* Total bilirubin =\< institutional upper limit of normal (at baseline \[pre-study\])
* Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase/alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase) =\< institutional upper limit of normal (at baseline \[pre-study\])
* Glomerular filtration rate (GFR) \>= 30 mL/min/1.73 m\^2 using the Cockcroft-Gault formula (at baseline \[pre-study\])
* Patients with a prior or concurrent malignancy (non-prostate) whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen as determined by the treating physician are eligible
* Given that worsening of an underlying state of mental depression or suicidal ideation…
What they're measuring
1
Number of Participants With Dose-limiting Toxicities (Treatment-related Adverse Events) as Assessed by the CTCAE v5.0