A Randomized, Placebo Controlled, Multicenter Phase 2 Study of Etodolac and Propranolol in Patients With Clinically Progressive Prostate Cancer

Vicus Therapeutics16 sites in 1 country35 target enrollmentJune 2013

ConditionsProstatic Neoplasms

InterventionsVT-122 Placebo

DrugsVT-122 Placebo

Overview

Phase: Phase 2
Intervention: VT-122
Conditions: Prostatic Neoplasms
Sponsor: Vicus Therapeutics
Enrollment: 35
Locations: 16
Primary Endpoint: Change in prostate specific antigen (PSA)
Status: Terminated
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the clinical benefit of the co-administration of propranolol and etodolac (VT-122 therapy) in patients with clinically progressive prostate cancer.

Registry

clinicaltrials.gov

Start Date

June 2013

End Date

April 2016

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Vicus Therapeutics

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Have a confirmed diagnosis of prostate cancer
•Male participants who are ≥18 years of age
•In the opinion of the investigator, the participants have a life expectancy of at least 3 months.
•Two consecutively rising PSA values or two out of three rising PSA values (2.0 ng/mL is the minimum ending value for PSA) at a minimum of 1-week intervals
•Have a Karnofsky Performance Score (KPS) equal to or greater than 70
•Have the following laboratory parameters (may be assessed locally):
•Platelet count ≥50 x 10E3/µL
•Total bilirubin ≤1.5 mg/dL
•Serum creatinine ≤1.5 x upper limit of normal (ULN) or creatinine clearance \>60 mL/min calculated using Cockcroft-Gault
•Liver enzymes \[aspartate transaminase (AST), alanine transaminase (ALT)\] ≤2 x ULN

Exclusion Criteria

•The patient has a history of another primary cancer, with the exception of:
•Curatively resected non-melanomatous skin cancer;
•Other primary solid tumor with no known active disease presents that in the opinion of the investigator that will not affect patient outcome in the setting of current prostate cancer diagnosis.
•Contraindication to propranolol, etodolac
•Patients on beta blockers
•Patients receiving chemotherapy (e.g., docetaxel, cabazitaxel, taxane, or platinum as single agents or in combination) as their cancer treatment
•History or evidence of cardiac disease: congestive heart failure; New York Heart Association class 2 or greater; active coronary artery disease; unstable angina, cardiac arrhythmias requiring anti-arrhythmic therapy, atrio-ventricular block of second or third degree, or uncontrolled hypertension, patients with recent (less than 6 months) myocardial infarction (MI) or coronary revascularization
•Hypotension at the time of screening (i.e., systolic blood pressure less than 110 mmHg. Diastolic blood pressure less than 60 mmHg)
•Resting heart rate less than 60 bpm at time of screening
•Any uncontrolled, intercurrent illness that in the opinion of the Investigator may interfere with study evaluation. Participants with uncontrolled diabetes will be excluded from the study.

Arms & Interventions

VT-122 with physician's choice therapy

Participants will receive oral doses of 66 mg propranolol and 680 mg etodolac daily. Propranolol will be administered 44 mg with breakfast and 22 mg in the mid-afternoon (3PM). Etodolac will be administered 340 mg with breakfast and 340 mg with dinner.

Intervention: VT-122

Placebo with physician's choice therapy

Participants will receive physician's choice therapy as the standard of care as well as the placebo capsules that are of the same weight as propranolol and etodolac.

Intervention: Placebo

Outcomes

Primary Outcomes

Change in prostate specific antigen (PSA)

Time Frame: baseline (Day 1 Cycle 1) to 12 weeks (Day 1, Cycle 4)

Secondary Outcomes

PSA progression(baseline to 12 weeks)
PSA doubling time (PSADT)(baseline and every month during treatment)
Change in self-reported performance (EQ-5D), pain (visual analog scale [VAS] and opiate usage)(Day 1 Cycle 1, on Day 1 of each subsequent 28-day cycle, and on end of treatment)
Time to symptom progression (TTSP)(Day 1 Cycle 1 and Day 1 of each subsequent 28-day cycle)
Change in correlative biomarkers(Day 1 Cycle 1, on Day 1 of each subsequent 28-day cycle, and on end of treatment)