The purpose of this study is to test the effectiveness (how well the drug works), safety, and tolerability of the investigational drug combination of ARRx (also known as AZD5312) plus enzalutamide in patients with metastatic castration resistant prostate cancer.
This is a single dose-finding one-arm phase Ib/II trial to determine the maximum tolerated dose (MTD) from among three dose levels of ARRx in combination with a fixed dose of enzalutamide and to obtain a preliminary estimate of efficacy at this MTD, as measured by PSA response rate. Success for the trial is defined as finding a dose level that is likely to be both tolerable and effective. The study was originally registered as a phase 1/ phase 2 study; however, the study was cancelled by the sponsor before opening the phase 2 portion. Outcome measures were updated to include those relevant to the Phase 1 portion as the study was terminated before enrolling into phase 2
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Given intravenously (IV)
Given by mouth (PO)
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Number of Subjects With Dose-limiting Toxicity (DLT) During the First Cycle of ARRx (in Combination With Enzalutamide)
DLTs will be counted based on the number of subjects with DLT at a given dose level. No single subject can trigger more than one DLT event. DLT is defined as any Grade 3 or higher toxicity as defined by CTCAE v5.0. Toxicity that is clearly and directly related to the primary disease or to another etiology is excluded from this definition.
Time frame: Up to day 21 of treatment
Best PSA Response
Number of subjects with at least 50% decline in PSA from Baseline
Time frame: 3.5 years
Percentage of Patients With a Reduction in PSA of at Least 30% From Baseline
Using PCWG3 criteria. Number of patient with a reduction in PSA of at least 30% from baseline
Time frame: 3.5 years
Overall Survival at One Year
One year KM estimate. Patients alive or lost to follow-up at the time of analysis will be censored at their last date of follow-up.
Time frame: 1 year
Intrapatient Dose Delays
Number of participants that experienced dose delays while on study treatment
Time frame: 3.5 years
Intrapatient Dose Reductions
Number of participants that experienced dose reductions while on study treatment
Time frame: 3.5 years
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