Efficacy and Safety Study of Etodolac and Propranolol in Patients With Clinically Progressive Prostate Cancer

NCT01857817 | Terminated Phase 2

• 1 other identifier: VT1-SYS-601
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 16

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.

Conditions

Prostatic Neoplasms

Outcome Measures

Primary Outcomes (1)

• Change in prostate specific antigen (PSA)

  baseline (Day 1 Cycle 1) to 12 weeks (Day 1, Cycle 4)

Secondary Outcomes (5)

• 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

Study Arms (2)

VT-122 with physician's choice therapy

EXPERIMENTAL

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.

Drug: VT-122

Placebo with physician's choice therapy

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

VT-122 DRUG

The following will be used in the study for VT-122: propranolol 22 mg immediate-release capsules and etodolac 340 mg capsules.

Also known as: propranolol, etodolac

VT-122 with physician's choice therapy

Placebo DRUG

The placebo capsules will be prepared to match the active drug.

Placebo with physician's choice therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Able to provide written informed consent prior to any study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time, for any reason without prejudice

You may not qualify if:

• 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.
• On chronotropic drugs (acetylcholine, digoxin, diltiazem, verapamil, atropine, dopamine, dobutamine, epinephrine, isoproterenol)
• Active clinically serious infections \[\> Grade 2 National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0\]
• Substance abuse, medical, psychological or social conditions that may, in the opinion of the investigator, interfere with the patient's participation in the study or evaluation of the study results
• Known or suspected allergy to the investigational agents or any agent given in association with this trial (hypersensitivity reaction, hives, rash, difficulty breathing swelling of your face, lips, tongue, or throat)
• Any condition that is unstable or which in the opinion of the Investigator could jeopardize the safety of the patient and his/her compliance in the study

Sponsors & Collaborators

• Vicus Therapeutics: lead

Study Sites (16)

Highlands Oncology Group

Fayetteville, Arkansas, 72703, United States

Location

Redwood Regional Medical Group

Santa Rosa, California, 95403, United States

Location

Advanced Urology

Parker, Colorado, 80134, United States

Location

Manatee Medical Research Institute, LLC

Bradenton, Florida, 34205, United States

Location

Baptist Cancer Institute

Jacksonville, Florida, 32207, United States

Location

Midwestern Regional Medical Center

Zion, Illinois, 60099, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Detroit Clinical Research Center, PC

Lansing, Michigan, 48912, United States

Location

Adult & Pediatric Urology

Sartell, Minnesota, 56377, United States

Location

AccuMed Research Associates

Garden City, New York, 11530, United States

Location

Premier Medical Group of the Hudson Valley PC

Poughkeepsie, New York, 12601, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Hendrick Cancer Center

Abilene, Texas, 79601, United States

Location

Oncology Consultants, P.A.

Houston, Texas, 77030, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

Medical Oncology Associates, PS

Spokane, Washington, 99208, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Propranolol; Etodolac

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Indoleacetic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2013
• First Posted: May 20, 2013
• Study Start: June 1, 2013
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: April 26, 2018

Record last verified: 2018-04

Locations

US (16)